Ignite Creation Date:
2024-05-06 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03687424
Status:
UNKNOWN
Last Update Posted:
2018-09-27
First Post:
2018-09-22
Brief Title:
Can High-flow Nasal Oxygenation Improve Oxygen Saturation During Analgo-sedation in Obese Adults
Sponsor:
University of Split School of Medicine
Organization:
University of Split School of Medicine
Study Overview
Official Title:
The Effect of High-flow Nasal Oxygenation vs Low-flow Nasal Oxygenation on Oxygen Saturation During Analgo-sedation in Obese Adult Patients Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2018-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Obesity is omnipresent problem in everyday anesthesiology practice associated with low level of blood oxygen hypoxemia during analgo-sedation Overweight outpatients are often scheduled for colonoscopy usually undergo analgo-sedation In obese patients intravenous analgo-sedation often diminish respiratory drive causing hypoxemia To avoid hypoxemia low-flow nasal oxygenation LFNO of 2-6 Lmin is applied via standard nasal catheter to provide maximum 40 of inspired fraction of oxygen FiO2 LFNO comprises applying cold and dry oxygen which causes discomfort to nasal mucosa of patient LFNO is often insufficient to provide satisfying oxygenation Insufficient oxygenation adds to circulatory instability - heart rate HR and blood pressure BP disorder
On the other side high-flow nasal oxygenation HFNO brings 20 to 70 Lmin of heated and humidified of O2air mixture up to 100 FiO2 via specially designed nasal cannula Heated and humidified O2air mixture is much more agreeable to patient HFNO brings noninvasive support to patients spontaneous breathing by producing continuous positive pressure of 3-7 cmH2O in upper airways consequently enhancing oxygenation
Investigators intend to analyze effect of HFNO vs LFNO on oxygen saturation during procedural analgo-sedation for colonoscopy in obese adult patients
Investigators expect that obese patients with preserved spontaneous breathing oxygenized by HFNO vs LFNO will be less prone to hypoxemia thus more respiratory and circulatory stable during procedural analgo-sedation for colonoscopy
Obese patients with applied HFNO should longer preserve normal oxygen saturation normal level of CO2 and O2 reflecting better respiratory stability Investigators expect obese participnts to have more stable HR and BP reflecting improved circulatory stability There will be less interruption of breathing pattern of obese patients and less necessity for attending anesthesiologist to intervene
On the other side high-flow nasal oxygenation HFNO brings 20 to 70 Lmin of heated and humidified of O2air mixture up to 100 FiO2 via specially designed nasal cannula Heated and humidified O2air mixture is much more agreeable to patient HFNO brings noninvasive support to patients spontaneous breathing by producing continuous positive pressure of 3-7 cmH2O in upper airways consequently enhancing oxygenation
Investigators intend to analyze effect of HFNO vs LFNO on oxygen saturation during procedural analgo-sedation for colonoscopy in obese adult patients
Investigators expect that obese patients with preserved spontaneous breathing oxygenized by HFNO vs LFNO will be less prone to hypoxemia thus more respiratory and circulatory stable during procedural analgo-sedation for colonoscopy
Obese patients with applied HFNO should longer preserve normal oxygen saturation normal level of CO2 and O2 reflecting better respiratory stability Investigators expect obese participnts to have more stable HR and BP reflecting improved circulatory stability There will be less interruption of breathing pattern of obese patients and less necessity for attending anesthesiologist to intervene
Detailed Description:
Obese patients are often scheduled for colonoscopy under analgo-sedation Analgo-sedation is characterized by deep conscious sedation and preserved spontaneous breathing Continuous intravenous application of sedatives favors patients circulatory stability and application of oxygenation contributes to maintaining adequate patients oxygenation Typically low-flow nasal oxygenation LFNO of 2-6 Lmin is applied via standard nasal catheter to provide maximum 40 of inspired fraction of oxygen FiO2 before preoxygenation during procedural oxygenation and after postprocedural oxygenation until patient regains consciousness
During analgo-sedation obese patients are prone to intervals of bradypnea and hypoventilation Transitory apnea in obese patients could lead to hypoxemia hypoxia hypercapnia and hemodynamic insufficiency despite LFNO application Fatal outcome may occur especially at higher risk overweight patients ASA III class Respiratory and hemodynamic stability of morbidly obese outpatients during analgo-sedation for endoscopic procedures represent challenge to anesthesiologists There is no generally accepted protocol of preoxygenation and intraoperative ventilatory management for obese patients Obese 30BMI40 kgm2 BMI body mass index and morbidly obese patients BMI 40 kgm2 are classified to higher anesthesia risk groups even if obese patients may not have other comorbidities 30BMI40 kgm2 ASA II BMI 40 kgm2 ASA III
Partial relaxation of pharyngeal muscles characteristic for analgo-sedation in overweight patients causes prolapse of fatty tissue that partially obstructs pharynx and can cause obstructive sleep apnoea OSA Although OSA is not related to obesity OSA can accompany obesity Besides perioperatively hypoxia and bradypnoea episodes occur postoperatively in obese patients which makes additional observation of obese patients necessary More frequent hypoxia and bradypnoea during awakening require additional respiratory effort Ventilation strategies in obese patients are necessary to optimize gas exchange and pulmonary mechanics in order to reduce pulmonary complications
High-flow nasal oxygenation HFNO brings 20 to 70 Lmin heated and humidified O2air mixture up to 100 FiO2 via specially designed soft nasal cannula HFNO brings non-invasive support to patients inspiratory effort by developing 3-7 cmH2O of continuous pressure in upper airway decreasing its resistance and dead space Also heated and humidified oxygenair mixture with possibility to bring higher FiO2 adds to better patients oxygenation preservation and improved patients comfort during procedure
AIM of this study is to compare effect of HFNO vs LFNO during standardized procedure of intravenous analgo-sedation on periprocedural oxygenation maintenance in patients of different weight groups 18BMI30 kgm2 30BMI40 kgm2 and BMI 40 kgm2
Investigators hypothesized that application of HFNO compared to LFNO in obese patients with preserved spontaneous breathing during procedural analgo-sedation contributes to maintaining adequate oxygenation consequently adding to greater peri-procedural circulatory and respiratory stability of obese patients Investigators expect that HFNO will ensure reduced bradypnoea intervals frequency of breathing FoB 1min longer maintenance of adequate oxygenation shorter intervals of desaturation SpO2 92 reducing hypercapnia PaCO2 6 kPa and less airway - opening maneuvers performed by attending anesthesiologist Aom These will prevent partial respiratory insufficiency detected by low SpO2 or low PaO2 11 kPa accompanied by normal or low PaCO2 6 kPa and global respiratory insufficiency detected by decreased SpO2 92 and PaO2 11 kPa with increased PaCO2 6 kPa
Investigators plan to conduct prospective parallel group randomized controlled clinical trial Trial will be managed according to principles of Declaration of Helsinki for scientific clinical research and will be planned and guided according to CONSORT guidelines Consolidated Standards of Reporting Trials The trial has been approved by hospitals Ethic Committee
The source of information are going to be 126 adult patients scheduled for colonoscopy under analgo-sedation in the setting of daily outpatient gastroenterology ambulance Eligible participants will be interviewed and examined ambulatory by anesthesiologist together with evaluation of ASA status difficulty of airway management and BMI After initial examination inclusive and exclusive criteria will be distinguished Eligible participants who give written consent of participation will be included in this trial After that participants will be assigned to equal normal weight 18BMI30 kgm2 obese 30BMI40 kgm2 or morbidly obese BMI 40 kgm2 group Each group will be randomized to intervention HFNO and control LFNO subgroup by random numbers generator Randomization will be used until adequate number of participants in every group is reached
Interventions intervention subgroups participants will be oxygenated via nasal cannula using high flow 40 Lmin of humidified and heated oxygen in air mixture FiO2 40 HFNO will be applied by oxygenator AirVO2 Fisher and Paykell New Zealand Technomedika Croatia doo during procedural analgo-sedation for colonoscopy with maintained spontaneous breathing In control subgroups oxygenation will be applied via nasal catheter Bauerfeind doo Zagreb Croatia using standard low flow oxygen 5 Lmin FiO2 40 LFNO In both groups concentration of oxygen delivered depends on oxygen flow which is regulated by standard flow-regulator flowmeter Oxygen is delivered through pipelines from central hospital gas supply or from portable cylinder gas supply
Anesthesia procedure will be uniformed for all participants Integrated noninvasive monitoring of vital functions will be set EKG - heart ratemin SpO2 blood pressure mmHg indirect respiration number of breathsmin Compact 7 Medical Econet GmbH Germany
Every participant will have established intravenous infusion of 250 ml NaCl 09 through intravenous cannula regulated by continuous flow Extension setCONTROL-A-FLO Regulator 19 Male Luer Lock Adapter BaxterAgmar doo United States of AmericaCroatia
Arterial cannula REF30401 20 G - 110 mm x 45 mm 49 ml atraumatic needle tip Medbar LTD Izmir Turkey will be placed in radial artery in a previously anesthetized area with local anesthetic EMLA
Oxygenation HFNO or LFNO will be administrated in continuity until patients awakening Oxygenation will be started 3 minutes before starting analgo-sedation preoxygenation continued during analgo-sedation and procedure of colonoscopy perioperative oxygenation and up to five minutes after colonoscopy and until patient is awaken postprocedural oxygenation
Intravenous analgo-sedation will be started through continuous infusions of propofol and fentanyl Induction of sedation will be guided by TCI Target control Infusion B Braun Melsungen Germany with initial target propofol concentration of 6 microgramsminute Expected time of induction with this concentration is 60-120 seconds This target concentration allows hemodynamic and respiratory stability Required analgesia will be simultaneously applied through slow continuous infusion in dose of 005 mcgkgmin in order to preserve spontaneous breathing Slow infusion will be applied through perfusor BBraun Melsungen Germany Analgo-sedation will be discontinued immediately after end of the procedure
Control of nasopharyngeal airway passage during procedure is achieved by using oropharyngeal airway if necessary Oropharyngeal airway Airway Vigon-Medicpro doo will be inserted after achieving moderate sedation and only if base of tongue is closing airway by dropping on posterior pharyngeal wall Every manipulation of patients airway by anesthesiologist will be documented insertion of airway jaw thrust maneuver
Sampling one milliliter of arterial blood will be collected as three consecutive samples from arterial cannula before during and after analgo-sedation Sample of arterial blood will be drawn from left radial or cubital artery
Measurements measurement of oxygenation will be done using two methods indirect noninvasive method using pulse oxymeter Compact 7 Medical ECONET GmbH Germany and direct invasive method from obtained arterial blood sample Measurement of SpO2 and drawing arterial blood sample will be done simultaneously Direct measurements of SpO2 and PaO2 will be taken in intervals of time SpO2 will be measured on the left-hand index finger Data will be uniformly collected through indirect - noninvasive SpO2 heart rate blood pressure respiratory rate and direct - invasive arterial blood gas analysis - pH PaO2 PaCO2 SaO2 measurements
Possible biases and confounding variables could be caused by hypothermia of participant by sphygmomanometer cuff pressure on the same arm where blood samples are drawn and by prolonged time of arterial blood analysis These difficulties can be bypassed by adjustment of room temperature where analgo-sedation is performed blood pressure measuring on opposite arm from where samples of blood are taken and by arterial blood gas analysis without delay
Basic data analyses will be performed by statistician Sample size is determined by statistic computing web program httpwwwstatubccarollinstatsssize used statistic test Inference for Proportions Comparing Two Independent Samples Assessment of sample size is computed for two independent samples with assumption of clinically significant difference in patients oxygenation 11 and 144 kPa with delta 44 Statistical significance of difference will be inferred with 5 α-error 50 β-error and study power 080 Calculated size of sample is 21 participant pro subgroup total of 126 participants
Investigators expect no changes to methods after trial commencement All potential unwanted events which may happen during analgo-sedation and colonoscopy that could cause deviation from this trials protocol will be reason for exclusion of participant from this trial If circumstances change anesthesiologist responsible for application of anesthesia will carry out procedure in way which is in patients best interest
During analgo-sedation obese patients are prone to intervals of bradypnea and hypoventilation Transitory apnea in obese patients could lead to hypoxemia hypoxia hypercapnia and hemodynamic insufficiency despite LFNO application Fatal outcome may occur especially at higher risk overweight patients ASA III class Respiratory and hemodynamic stability of morbidly obese outpatients during analgo-sedation for endoscopic procedures represent challenge to anesthesiologists There is no generally accepted protocol of preoxygenation and intraoperative ventilatory management for obese patients Obese 30BMI40 kgm2 BMI body mass index and morbidly obese patients BMI 40 kgm2 are classified to higher anesthesia risk groups even if obese patients may not have other comorbidities 30BMI40 kgm2 ASA II BMI 40 kgm2 ASA III
Partial relaxation of pharyngeal muscles characteristic for analgo-sedation in overweight patients causes prolapse of fatty tissue that partially obstructs pharynx and can cause obstructive sleep apnoea OSA Although OSA is not related to obesity OSA can accompany obesity Besides perioperatively hypoxia and bradypnoea episodes occur postoperatively in obese patients which makes additional observation of obese patients necessary More frequent hypoxia and bradypnoea during awakening require additional respiratory effort Ventilation strategies in obese patients are necessary to optimize gas exchange and pulmonary mechanics in order to reduce pulmonary complications
High-flow nasal oxygenation HFNO brings 20 to 70 Lmin heated and humidified O2air mixture up to 100 FiO2 via specially designed soft nasal cannula HFNO brings non-invasive support to patients inspiratory effort by developing 3-7 cmH2O of continuous pressure in upper airway decreasing its resistance and dead space Also heated and humidified oxygenair mixture with possibility to bring higher FiO2 adds to better patients oxygenation preservation and improved patients comfort during procedure
AIM of this study is to compare effect of HFNO vs LFNO during standardized procedure of intravenous analgo-sedation on periprocedural oxygenation maintenance in patients of different weight groups 18BMI30 kgm2 30BMI40 kgm2 and BMI 40 kgm2
Investigators hypothesized that application of HFNO compared to LFNO in obese patients with preserved spontaneous breathing during procedural analgo-sedation contributes to maintaining adequate oxygenation consequently adding to greater peri-procedural circulatory and respiratory stability of obese patients Investigators expect that HFNO will ensure reduced bradypnoea intervals frequency of breathing FoB 1min longer maintenance of adequate oxygenation shorter intervals of desaturation SpO2 92 reducing hypercapnia PaCO2 6 kPa and less airway - opening maneuvers performed by attending anesthesiologist Aom These will prevent partial respiratory insufficiency detected by low SpO2 or low PaO2 11 kPa accompanied by normal or low PaCO2 6 kPa and global respiratory insufficiency detected by decreased SpO2 92 and PaO2 11 kPa with increased PaCO2 6 kPa
Investigators plan to conduct prospective parallel group randomized controlled clinical trial Trial will be managed according to principles of Declaration of Helsinki for scientific clinical research and will be planned and guided according to CONSORT guidelines Consolidated Standards of Reporting Trials The trial has been approved by hospitals Ethic Committee
The source of information are going to be 126 adult patients scheduled for colonoscopy under analgo-sedation in the setting of daily outpatient gastroenterology ambulance Eligible participants will be interviewed and examined ambulatory by anesthesiologist together with evaluation of ASA status difficulty of airway management and BMI After initial examination inclusive and exclusive criteria will be distinguished Eligible participants who give written consent of participation will be included in this trial After that participants will be assigned to equal normal weight 18BMI30 kgm2 obese 30BMI40 kgm2 or morbidly obese BMI 40 kgm2 group Each group will be randomized to intervention HFNO and control LFNO subgroup by random numbers generator Randomization will be used until adequate number of participants in every group is reached
Interventions intervention subgroups participants will be oxygenated via nasal cannula using high flow 40 Lmin of humidified and heated oxygen in air mixture FiO2 40 HFNO will be applied by oxygenator AirVO2 Fisher and Paykell New Zealand Technomedika Croatia doo during procedural analgo-sedation for colonoscopy with maintained spontaneous breathing In control subgroups oxygenation will be applied via nasal catheter Bauerfeind doo Zagreb Croatia using standard low flow oxygen 5 Lmin FiO2 40 LFNO In both groups concentration of oxygen delivered depends on oxygen flow which is regulated by standard flow-regulator flowmeter Oxygen is delivered through pipelines from central hospital gas supply or from portable cylinder gas supply
Anesthesia procedure will be uniformed for all participants Integrated noninvasive monitoring of vital functions will be set EKG - heart ratemin SpO2 blood pressure mmHg indirect respiration number of breathsmin Compact 7 Medical Econet GmbH Germany
Every participant will have established intravenous infusion of 250 ml NaCl 09 through intravenous cannula regulated by continuous flow Extension setCONTROL-A-FLO Regulator 19 Male Luer Lock Adapter BaxterAgmar doo United States of AmericaCroatia
Arterial cannula REF30401 20 G - 110 mm x 45 mm 49 ml atraumatic needle tip Medbar LTD Izmir Turkey will be placed in radial artery in a previously anesthetized area with local anesthetic EMLA
Oxygenation HFNO or LFNO will be administrated in continuity until patients awakening Oxygenation will be started 3 minutes before starting analgo-sedation preoxygenation continued during analgo-sedation and procedure of colonoscopy perioperative oxygenation and up to five minutes after colonoscopy and until patient is awaken postprocedural oxygenation
Intravenous analgo-sedation will be started through continuous infusions of propofol and fentanyl Induction of sedation will be guided by TCI Target control Infusion B Braun Melsungen Germany with initial target propofol concentration of 6 microgramsminute Expected time of induction with this concentration is 60-120 seconds This target concentration allows hemodynamic and respiratory stability Required analgesia will be simultaneously applied through slow continuous infusion in dose of 005 mcgkgmin in order to preserve spontaneous breathing Slow infusion will be applied through perfusor BBraun Melsungen Germany Analgo-sedation will be discontinued immediately after end of the procedure
Control of nasopharyngeal airway passage during procedure is achieved by using oropharyngeal airway if necessary Oropharyngeal airway Airway Vigon-Medicpro doo will be inserted after achieving moderate sedation and only if base of tongue is closing airway by dropping on posterior pharyngeal wall Every manipulation of patients airway by anesthesiologist will be documented insertion of airway jaw thrust maneuver
Sampling one milliliter of arterial blood will be collected as three consecutive samples from arterial cannula before during and after analgo-sedation Sample of arterial blood will be drawn from left radial or cubital artery
Measurements measurement of oxygenation will be done using two methods indirect noninvasive method using pulse oxymeter Compact 7 Medical ECONET GmbH Germany and direct invasive method from obtained arterial blood sample Measurement of SpO2 and drawing arterial blood sample will be done simultaneously Direct measurements of SpO2 and PaO2 will be taken in intervals of time SpO2 will be measured on the left-hand index finger Data will be uniformly collected through indirect - noninvasive SpO2 heart rate blood pressure respiratory rate and direct - invasive arterial blood gas analysis - pH PaO2 PaCO2 SaO2 measurements
Possible biases and confounding variables could be caused by hypothermia of participant by sphygmomanometer cuff pressure on the same arm where blood samples are drawn and by prolonged time of arterial blood analysis These difficulties can be bypassed by adjustment of room temperature where analgo-sedation is performed blood pressure measuring on opposite arm from where samples of blood are taken and by arterial blood gas analysis without delay
Basic data analyses will be performed by statistician Sample size is determined by statistic computing web program httpwwwstatubccarollinstatsssize used statistic test Inference for Proportions Comparing Two Independent Samples Assessment of sample size is computed for two independent samples with assumption of clinically significant difference in patients oxygenation 11 and 144 kPa with delta 44 Statistical significance of difference will be inferred with 5 α-error 50 β-error and study power 080 Calculated size of sample is 21 participant pro subgroup total of 126 participants
Investigators expect no changes to methods after trial commencement All potential unwanted events which may happen during analgo-sedation and colonoscopy that could cause deviation from this trials protocol will be reason for exclusion of participant from this trial If circumstances change anesthesiologist responsible for application of anesthesia will carry out procedure in way which is in patients best interest
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None