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Effect of Positive End Expiratory Pressure at the Time of Induction in Morbidly Obese Patients

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03024658
Enrollment
70
Registered
2017-01-19
Start date
2015-05-31
Completion date
2016-08-31
Last updated
2017-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity

Keywords

Pulmonary artery systolic pressure, Positive end expiratory pressure, morbidly obese, laparoscopic bariatric surgery

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 \> 40kg/m2, 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 & P.G. 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 \> 40kg/m2, 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 and/or 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 i.v. Glycopyrolate (0.005-0.01 mg/kg), i.v. Fentanyl (2µg/kg) and i.v. Propofol. Once the patient became unresponsive to verbal commands, Succinylcholine was then administered in a dose of 1- 1.5 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 (n=19)

Interventions

Positive end expiratory pressure was applied using anesthesia machine at the time of induction in the patients undergoing laparoscopic bariatric surgery

Sponsors

Sri Aurobindo Institute of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Patients recruited were * Anesthesia society of Anesthesiologist (ASA) physical status l, II or III, * Aged 20-65 years * BMI \> 40kg/m2 * scheduled for elective laparoscopic bariatric surgery

Exclusion criteria

* Patients who denied consent * Did not fulfill the inclusion criteria, * patients undergoing Emergency and/or open surgery * Patients requiring more than 2 attempts for intubation

Design outcomes

Primary

MeasureTime frameDescription
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of inductionArterial oxygenation (PaO2) in mm Hg recorded preoperatively and taken as baseline valueArterial oxygenation (PaO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction of general anesthesiaArterial carbon di oxide (PaCO2) in mm Hg was recorded from ABG preoperatively and taken as baseline valueArterial carbon di oxide (PaCO2) values in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater

Secondary

MeasureTime frameDescription
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parametersABG and hemodynamic parameters were recorded preoperatively and taken as baseline valuePreoperative arterial oxygenation was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP \> 30 mm Hg receiving PEEP with those not receiving any PEEP

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026