Ignite Creation Date:
2024-05-06 @ 9:35 AM
Last Modification Date:
2024-10-26 @ 12:17 PM
Study NCT ID:
NCT03024658
Status:
COMPLETED
Last Update Posted:
2017-01-19
First Post:
2017-01-06
Brief Title:
Effect of Positive End Expiratory Pressure at the Time of Induction in Morbidly Obese Patients
Sponsor:
Sri Aurobindo Institute of Medical Sciences
Organization:
Sri Aurobindo Institute of Medical Sciences
Study Overview
Official Title:
Single Minute of Positive End Expiratory Pressure at the Time of Induction Effect on Arterial Blood Gases and Hemodynamics in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery
Status:
COMPLETED
Status Verified Date:
2017-01
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:
Background Positive end expiratory pressure PEEP at the time of induction increases oxygenation by preventing lung atelectasis However PEEP may not prove beneficial in all cases Factors affecting the action of PEEP have not been elucidated well and remain controversial Pulmonary vasculature has direct bearing on the action of PEEP as has been proven in previous studies Thus this study was planned to evaluate the action of PEEP on the basis of pulmonary artery systolic pressure PASP which is non invasive and easily measured by trans-thoracic echocardiography
Methodology This Randomized prospective study comprised of 70 morbidly obese patients ASA grade II or III aged 20-65 years with BMI 40kgm2 scheduled for elective laparoscopic bariatric surgery Ten patients had to be excluded Thus a total of 60 patients participated in the study Thirty patients received no PEEP at the time of induction while other 30 patients were given a PEEP of 10cm of H2O Serial ABG samples were taken pre operatively at the time of intubation 5 min after intubation and 10 min after intubation Patients were then divided into four groups on the basis of PASP value of 30 mm Hg with and without PEEP or 30 mm Hg
Methodology This Randomized prospective study comprised of 70 morbidly obese patients ASA grade II or III aged 20-65 years with BMI 40kgm2 scheduled for elective laparoscopic bariatric surgery Ten patients had to be excluded Thus a total of 60 patients participated in the study Thirty patients received no PEEP at the time of induction while other 30 patients were given a PEEP of 10cm of H2O Serial ABG samples were taken pre operatively at the time of intubation 5 min after intubation and 10 min after intubation Patients were then divided into four groups on the basis of PASP value of 30 mm Hg with and without PEEP or 30 mm Hg
Detailed Description:
This prospective study was conducted in the Department Of Anaesthesiology Critical Care Sri Aurobindo Institute of Medical Sciences PG Institute and Mohak Hospitals Indore over a period of one year Seventy morbidly obese patients ASA grade II or III aged 20-65 years with BMI 40kgm2 scheduled for elective laparoscopic bariatric surgery were selected and a written informed consent was obtained All the recruited patients underwent 2D-trans-thoracic echocardiography and PASP was recorded Echocardiography was performed by same cardiologist as this measurement is operator dependent Patients who denied consent those undergoing Emergency andor open surgery and those requiring more than 2 attempts for intubation were excluded
Arterial line was inserted pre operatively and ABG sample was taken and hemodynamic parameter recording done while the patient was breathing room air Both groups were pre-oxygenated for 3 minutes with 100 Oxygen Standard procedure was used for induction of anesthesia in all the patients No premedication was given All the patients were induced with iv Glycopyrolate 0005-001 mgkg iv Fentanyl 2µgkg and iv Propofol Once the patient became unresponsive to verbal commands Succinylcholine was then administered in a dose of 1- 15 mg kg Mechanical ventilation was started with 100 oxygen A PEEP of 10 cm H2O was applied using four hand technique in Study group while the control group received no PEEP After one minute endotracheal intubation was done PEEP was continued in study group after intubation
Arterial blood gas ABG analysis and hemodynamic parameters were recorded at following stages
1 Just after inflation of cuff of endotracheal tube
2 5 minutes post intubation
3 10 minutes post intubation
Patients were then again divided into four groups on the basis of PASP
Group 1 Patients with PASP 30 mmHg receiving no PEEP n 11 Group 2 PASP 30 mm Hg receiving PEEP of 10 cm H2O n 11 Group 3 PASP 30 mm Hg receiving no PEEP n 19 Group 4 PASP 30 mm Hg receiving PEEP of 10 cm H2O n19
Arterial line was inserted pre operatively and ABG sample was taken and hemodynamic parameter recording done while the patient was breathing room air Both groups were pre-oxygenated for 3 minutes with 100 Oxygen Standard procedure was used for induction of anesthesia in all the patients No premedication was given All the patients were induced with iv Glycopyrolate 0005-001 mgkg iv Fentanyl 2µgkg and iv Propofol Once the patient became unresponsive to verbal commands Succinylcholine was then administered in a dose of 1- 15 mg kg Mechanical ventilation was started with 100 oxygen A PEEP of 10 cm H2O was applied using four hand technique in Study group while the control group received no PEEP After one minute endotracheal intubation was done PEEP was continued in study group after intubation
Arterial blood gas ABG analysis and hemodynamic parameters were recorded at following stages
1 Just after inflation of cuff of endotracheal tube
2 5 minutes post intubation
3 10 minutes post intubation
Patients were then again divided into four groups on the basis of PASP
Group 1 Patients with PASP 30 mmHg receiving no PEEP n 11 Group 2 PASP 30 mm Hg receiving PEEP of 10 cm H2O n 11 Group 3 PASP 30 mm Hg receiving no PEEP n 19 Group 4 PASP 30 mm Hg receiving PEEP of 10 cm H2O n19
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None