Ignite Creation Date:
2024-05-06 @ 7:17 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05964309
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-27
First Post:
2023-06-11
Brief Title:
Pre-oxygenation in Sitting Position and Oxygen Reserve Index
Sponsor:
Imam Abdulrahman Bin Faisal University
Organization:
Imam Abdulrahman Bin Faisal University
Study Overview
Official Title:
Effect of Preoxygenation in Sitting Position on The Oxygen Reserve Index ORI Alarm Time as Early Predictor of Impending Hypoxemia During Prolonged Apnea
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
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:
This prospective controlled and randomized study aims at comparing the effect of position on the oxygen reserve index alarm time which is considered as predictor of hypoxemia in prolonged apnea which might be faced during general anesthesia GA in several situations such as the time from induction of anesthesia till endotracheal intubation
participants will be divided into two groups supine n38 and sitting group n38 both group will undergo elective procedures under GA and endotracheal intubation
participants will be divided into two groups supine n38 and sitting group n38 both group will undergo elective procedures under GA and endotracheal intubation
Detailed Description:
Introduction Pre oxygenation with high fraction of inspired oxygen is not only recommended before anesthesia induction and intubation but also to delay apnea induced hypoxemia in a variety of airway management and patients with limited oxygen reserve As well as to prolong the duration of apneic oxygenation in some airway interventions Several methods have been used to improve the efficiency of pre oxygenation with controversial outcome One of these methods is the performance of pre oxygenation in head up position
During anesthetic management pulse oximeter has been considered as valuable noninvasive tool for monitoring of patient oxygen saturation SpO2
However the relationship between the oxygen saturation SpO2 and the arterial partial pressure of oxygen PaO2 restricts the pulse oximeter monitoring of patient oxygenation due to the sigmoidal pattern of this relation as small changes only in SpO2 occur with increase in arterial oxygen tension above 80 mmHg Therefore when oxygen is provided SpO2 remains 100 over a wide range of PaO2 80 mmHg So It does not reflect the degree of hyperoxia during oxygen supplementation On the other hand when PaO2 is falling the SpO2 may remain 100 until the PaO2 falls below approximately 80 mm Hg Thus it does not predict the onset of hypoxia in an apneic patient
Oxygen reserve index ORI is a non-invasive real time non-unit scale between 000 and 100 which reflects the level of venous blood oxygen saturation SvO2 When the patient is breathing room air ORI is 000 With oxygen supplementation after SpO2 reaches its plateau of 100 SvO2 continues rising as PaO2 increasing and at PaO2 200mmHg usually ORI reaches a plateau Hence ORI will serve to indicate PaO2 trends rising or falling in the range of 100-200 mmHg so it will reflect the range of moderate hyperoxia PaO2 ranging from 100 to 200 mmHg during oxygen supply and on the other hand it will predict impending desaturation ahead of standard pulse oximetry during safe prolonged apnea technique in surgical patients at high risk
Our study aims at assessment of the effect of pre oxygenation in sitting position on the ORI warning time for impending de-saturation during safe prolonged apnea techniques
Methodology After approval of Institution Review Board and obtaining written informed consent from all participants this prospective randomized controlled study will be conducted at King Fahd University hospital Written informed consent will be obtained from 56 illegible participants scheduled for elective surgery with planned general anesthesia with endotracheal intubation and invasive blood pressure monitoring arterial line
According to the head position during pre-oxygenation participants will be randomly allocated via a computer-generated sequence into two groups supine group flat head position- n28 and sitting group 90 degree head up position- n28
In the operation room standard monitoring will be applied ORI sensor Masimo RD lite will be attached to the participant finger
After recording the baseline vital signs pre oxygenation in the three groups will be started by asking participants to spontaneously breath 100 oxygen via a well fitted face mask for 3 minutes with rising of end-tidal fraction of oxygen EtO2 to at least 09 andor ORI to a plateau value Rapid sequence induction and intubation using fentanyl propofol and succinylcholine will be performed with the aid of video assisted laryngoscope The appropriate position of the endotracheal tube will be confirmed with direct vision and will be disconnected from the breathing circuit to prevent oxygenation while the patient is apneic and exposed to the room air until SpO2 decreased to 94 then tube will be connected to the breathing circuit Thereafter ventilator setting and anesthetic management will be according to the decision of the anesthesiologist assigned for patient care at this operative theater ORI SpO2 and PaO2 data were measured at four specific times 1 baseline 2 at the end of pre-oxygenation 3 at ORI alarm 4 when SpO2 reached 94 The participant will be excluded from the study if he has failed pre oxygenation EtO2 09 andor ORI does not reach a plateau value after 3 min pre oxygenation
Statistical analysis If the difference between the mean ORI alarm time in the sitting group and the supine group is assumed to be 25 seconds and a pooled standard deviation of 33 seconds 28 participants in each group with a total of 56 participant would be an appropriate sample size to provide a significance of 5 and a power of 80
Data that will be normally distributed will be compared using t-test Whereas Mann-Whitney test will be used to compare data with abnormal distribution Fishers exact test or Chi square test will be used to compare categorical data or gender ratio Probability p-value less than 005 will be considered statistically significant
During anesthetic management pulse oximeter has been considered as valuable noninvasive tool for monitoring of patient oxygen saturation SpO2
However the relationship between the oxygen saturation SpO2 and the arterial partial pressure of oxygen PaO2 restricts the pulse oximeter monitoring of patient oxygenation due to the sigmoidal pattern of this relation as small changes only in SpO2 occur with increase in arterial oxygen tension above 80 mmHg Therefore when oxygen is provided SpO2 remains 100 over a wide range of PaO2 80 mmHg So It does not reflect the degree of hyperoxia during oxygen supplementation On the other hand when PaO2 is falling the SpO2 may remain 100 until the PaO2 falls below approximately 80 mm Hg Thus it does not predict the onset of hypoxia in an apneic patient
Oxygen reserve index ORI is a non-invasive real time non-unit scale between 000 and 100 which reflects the level of venous blood oxygen saturation SvO2 When the patient is breathing room air ORI is 000 With oxygen supplementation after SpO2 reaches its plateau of 100 SvO2 continues rising as PaO2 increasing and at PaO2 200mmHg usually ORI reaches a plateau Hence ORI will serve to indicate PaO2 trends rising or falling in the range of 100-200 mmHg so it will reflect the range of moderate hyperoxia PaO2 ranging from 100 to 200 mmHg during oxygen supply and on the other hand it will predict impending desaturation ahead of standard pulse oximetry during safe prolonged apnea technique in surgical patients at high risk
Our study aims at assessment of the effect of pre oxygenation in sitting position on the ORI warning time for impending de-saturation during safe prolonged apnea techniques
Methodology After approval of Institution Review Board and obtaining written informed consent from all participants this prospective randomized controlled study will be conducted at King Fahd University hospital Written informed consent will be obtained from 56 illegible participants scheduled for elective surgery with planned general anesthesia with endotracheal intubation and invasive blood pressure monitoring arterial line
According to the head position during pre-oxygenation participants will be randomly allocated via a computer-generated sequence into two groups supine group flat head position- n28 and sitting group 90 degree head up position- n28
In the operation room standard monitoring will be applied ORI sensor Masimo RD lite will be attached to the participant finger
After recording the baseline vital signs pre oxygenation in the three groups will be started by asking participants to spontaneously breath 100 oxygen via a well fitted face mask for 3 minutes with rising of end-tidal fraction of oxygen EtO2 to at least 09 andor ORI to a plateau value Rapid sequence induction and intubation using fentanyl propofol and succinylcholine will be performed with the aid of video assisted laryngoscope The appropriate position of the endotracheal tube will be confirmed with direct vision and will be disconnected from the breathing circuit to prevent oxygenation while the patient is apneic and exposed to the room air until SpO2 decreased to 94 then tube will be connected to the breathing circuit Thereafter ventilator setting and anesthetic management will be according to the decision of the anesthesiologist assigned for patient care at this operative theater ORI SpO2 and PaO2 data were measured at four specific times 1 baseline 2 at the end of pre-oxygenation 3 at ORI alarm 4 when SpO2 reached 94 The participant will be excluded from the study if he has failed pre oxygenation EtO2 09 andor ORI does not reach a plateau value after 3 min pre oxygenation
Statistical analysis If the difference between the mean ORI alarm time in the sitting group and the supine group is assumed to be 25 seconds and a pooled standard deviation of 33 seconds 28 participants in each group with a total of 56 participant would be an appropriate sample size to provide a significance of 5 and a power of 80
Data that will be normally distributed will be compared using t-test Whereas Mann-Whitney test will be used to compare data with abnormal distribution Fishers exact test or Chi square test will be used to compare categorical data or gender ratio Probability p-value less than 005 will be considered statistically significant
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