Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05696860
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-01-25
First Post:
2022-12-26
Brief Title:
Microstream Capnography in Endobronchial Ultrasonography Applications Under Sedation
Sponsor:
Uludag University
Organization:
Uludag University
Study Overview
Official Title:
The Effect of Microstream Capnography on Patient Safety in Endobronchial Ultrasonography Applications Under Sedation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-01
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:
Purpose Researchers wanted to investigate the effect of capnography monitoring in addition to routine monitoring on the development of desaturation and other vital parameters in endobronchial ultrasonography EBUS cases
Method 100 patients who underwent EBUS under sedation will be included in this prospective and randomized controlled study The cases will be divided into two groups of 50 people each In the first group standard monitoring will be performed and in the second group in addition to standard monitoring capnography monitoring will be used Heart rate blood pressure peripheral oxygen saturation SpO2 values in both groups end-tidal carbon dioxide EtCO2 respiratory rate and integrated pulmonary index IPI values in the second group will be recorded in all cases Disturbances in vital parameters and airway interventions which were common in both groups will ve compared The frequency of problems detected by capnography monitoring in the second group will be examined
Method 100 patients who underwent EBUS under sedation will be included in this prospective and randomized controlled study The cases will be divided into two groups of 50 people each In the first group standard monitoring will be performed and in the second group in addition to standard monitoring capnography monitoring will be used Heart rate blood pressure peripheral oxygen saturation SpO2 values in both groups end-tidal carbon dioxide EtCO2 respiratory rate and integrated pulmonary index IPI values in the second group will be recorded in all cases Disturbances in vital parameters and airway interventions which were common in both groups will ve compared The frequency of problems detected by capnography monitoring in the second group will be examined
Detailed Description:
Endobronchial ultrasonography EBUS is an examination method that has been increasingly used in diagnosing and staging lung cancer mediastinal lymphadenopathy and masses in recent years This procedure is performed under anesthesia General anesthesia or sedation is generally preferred as an anesthesia option Desaturation may frequently develop during this procedure Follow-up with standard perioperative monitoring methods heart rate - HR respiratory rate - SS peripheral oxygen saturation - SpO2 is not a proper approach to detecting respiratory depression before desaturation develops
Capnography is a monitoring method that detects respiratory depression before desaturation develops by making instant end-tidal carbon dioxide EtCO2 measurements It has been stated that it significantly reduces the risk of desaturation in many surgical and interventional procedures performed under sedation and general anesthesia In addition respiratory disorders such as bronchospasm apnea or hypopnea can be detected by capnography However there is no information about capnographys effect on desaturation development or its contribution to standard monitoring in EBUS cases
The purpose of this study was to investigate the effects of capnography monitoring in addition to routine monitoring on the development of desaturation and other vital parameters in EBUS cases under moderate sedation according to the Ramsay Sedation Scale RSS The primary aim was to compare the groups in terms of the development of desaturation and the secondary aim was in terms of duration of hypoxemia development of severe hypoxemia lowest SpO2 value development of hypotension and bradycardia
150 patients who will undergo elective EBUS procedure have scores between 1-3 according to the American Society of Anesthesiologists ASA classification are pregnant or not suspected of pregnancy approve the informed consent form and are not allergic to the sedation agents to be used will be included in the study Patients with an ASA score of 4 and above pregnant or suspected pregnancy patients with difficult airway features and emergency cases will be excluded from the study
The cases will be divided into two groups of 75 people using the closed envelope method There will be cases in which capnography monitorization was performed in group 1 experimental group and cases in which capnography monitoring was not performed in group 2 control group In all cases age gender weight height ASA class doses of applied anesthesia drugs and smoking history will be recorded After obtaining informed consent in all cases Standard monitoring and BIS monitoring will be performed before sedation including HR SS SpO2 BP and 3-lead electrocardiographic analysis In addition to standard monitoring in patients in Group 1 ETCO2 integrated pulmonary index IPI will be measured non-invasively prior to sedation through a nasal cannula FilterLine connected to the capnography device Capnostream 20p Sedation and analgesia will be performed in accordance with the routine sedation-analgesia protocol used by our department in EBUS cases There will be no changes to the routine protocol In accordance with this protocol after the patient is taken to the operating room 5 ml of 2 lidocaine will be applied with a reservoir mask for topical anesthesia As a sedative agent 1-2 mg of midazolam will be administered intravenously A nasopharyngeal airway will be placed and 5 ltmin oxygen will be given to all patients throughout the operation In induction remifentanil will be administered at a level of 004 µgkgmin and Propofol at a level of 05-1 mgkghour The target sedation level will be determined as 60-80 BIS score and will be level 3 moderate sedation sleepy but responsive to verbal stimuli according to the Ramsey Sedation Scale All parameters measured before sedation in both groups It will be recorded at 3 minutes 6 minutes 9 minutes after sedation and at 3-minute intervals until the end of the operation
During the operation in the cases in Group 1 apnea the ETCO2 waveform is not seen for 10 seconds hypopnea at least 50 decrease in the peak ETCO2 level in 2 consecutive waveforms compared to the initial value and the peak ETCO2 level in the second wave is lower than the first and the number of bronchospasm The number of episodes of cough tachycardia bradycardia hypoxemia SpO290 in both groups duration of anesthesia duration of the procedure time between insertion and removal of the bronchoscope and recovery time spontaneous opening of the eyes of the patients with the removal of the bronchoscope performing the finger-nose test and the time elapsed between the time he was able to tell his birth dates will be recorded If bronchospasm upper airway obstruction apnea bradypnea develop during the procedure jaw-thrust maneuvers head-tilt maneuvers verbal and tactile warnings will be recorded
After the operation the cases will be taken to the recovery unit From the moment of entry in the recovery unit BP EtCO2 SpO2 and IPI values will be recorded every 5 minutes until the exit time In accordance with the routine sobering protocol Patients with a Modified Aldrete Score of 9 or higher will be sent to the clinic
The frequency and interrelationship of the parameters evaluated in both groups will be examined Between the group that underwent capnography and the group that did not It will be investigated whether there is a significant difference in terms of apnea desaturation episodes and interventions
Capnography is a monitoring method that detects respiratory depression before desaturation develops by making instant end-tidal carbon dioxide EtCO2 measurements It has been stated that it significantly reduces the risk of desaturation in many surgical and interventional procedures performed under sedation and general anesthesia In addition respiratory disorders such as bronchospasm apnea or hypopnea can be detected by capnography However there is no information about capnographys effect on desaturation development or its contribution to standard monitoring in EBUS cases
The purpose of this study was to investigate the effects of capnography monitoring in addition to routine monitoring on the development of desaturation and other vital parameters in EBUS cases under moderate sedation according to the Ramsay Sedation Scale RSS The primary aim was to compare the groups in terms of the development of desaturation and the secondary aim was in terms of duration of hypoxemia development of severe hypoxemia lowest SpO2 value development of hypotension and bradycardia
150 patients who will undergo elective EBUS procedure have scores between 1-3 according to the American Society of Anesthesiologists ASA classification are pregnant or not suspected of pregnancy approve the informed consent form and are not allergic to the sedation agents to be used will be included in the study Patients with an ASA score of 4 and above pregnant or suspected pregnancy patients with difficult airway features and emergency cases will be excluded from the study
The cases will be divided into two groups of 75 people using the closed envelope method There will be cases in which capnography monitorization was performed in group 1 experimental group and cases in which capnography monitoring was not performed in group 2 control group In all cases age gender weight height ASA class doses of applied anesthesia drugs and smoking history will be recorded After obtaining informed consent in all cases Standard monitoring and BIS monitoring will be performed before sedation including HR SS SpO2 BP and 3-lead electrocardiographic analysis In addition to standard monitoring in patients in Group 1 ETCO2 integrated pulmonary index IPI will be measured non-invasively prior to sedation through a nasal cannula FilterLine connected to the capnography device Capnostream 20p Sedation and analgesia will be performed in accordance with the routine sedation-analgesia protocol used by our department in EBUS cases There will be no changes to the routine protocol In accordance with this protocol after the patient is taken to the operating room 5 ml of 2 lidocaine will be applied with a reservoir mask for topical anesthesia As a sedative agent 1-2 mg of midazolam will be administered intravenously A nasopharyngeal airway will be placed and 5 ltmin oxygen will be given to all patients throughout the operation In induction remifentanil will be administered at a level of 004 µgkgmin and Propofol at a level of 05-1 mgkghour The target sedation level will be determined as 60-80 BIS score and will be level 3 moderate sedation sleepy but responsive to verbal stimuli according to the Ramsey Sedation Scale All parameters measured before sedation in both groups It will be recorded at 3 minutes 6 minutes 9 minutes after sedation and at 3-minute intervals until the end of the operation
During the operation in the cases in Group 1 apnea the ETCO2 waveform is not seen for 10 seconds hypopnea at least 50 decrease in the peak ETCO2 level in 2 consecutive waveforms compared to the initial value and the peak ETCO2 level in the second wave is lower than the first and the number of bronchospasm The number of episodes of cough tachycardia bradycardia hypoxemia SpO290 in both groups duration of anesthesia duration of the procedure time between insertion and removal of the bronchoscope and recovery time spontaneous opening of the eyes of the patients with the removal of the bronchoscope performing the finger-nose test and the time elapsed between the time he was able to tell his birth dates will be recorded If bronchospasm upper airway obstruction apnea bradypnea develop during the procedure jaw-thrust maneuvers head-tilt maneuvers verbal and tactile warnings will be recorded
After the operation the cases will be taken to the recovery unit From the moment of entry in the recovery unit BP EtCO2 SpO2 and IPI values will be recorded every 5 minutes until the exit time In accordance with the routine sobering protocol Patients with a Modified Aldrete Score of 9 or higher will be sent to the clinic
The frequency and interrelationship of the parameters evaluated in both groups will be examined Between the group that underwent capnography and the group that did not It will be investigated whether there is a significant difference in terms of apnea desaturation episodes and interventions
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