| CTRI Number |
CTRI/2020/08/027263 [Registered on: 20/08/2020] Trial Registered Prospectively |
| Last Modified On: |
11/08/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effects of postural maneuvering and baseline ventilator pressure at end of expiration on lung collapse during Laparoscopic Cholecystectomy Surgery |
|
Scientific Title of Study
|
Effects of Postural Recruitment Maneuver and Positive End-Expiratory Pressure on Lung Atelectasis during Laparoscopic Cholecystectomy Surgery: A prospective, randomized study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gaurav Jain |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Anaesthesiology AIIMS Rishikesh Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8808631209 |
| Fax |
|
| Email |
icubhu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurav Jain |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Anaesthesiology AIIMS Rishikesh Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8808631209 |
| Fax |
|
| Email |
icubhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gaurav Jain |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Anaesthesiology AIIMS Rishikesh Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8808631209 |
| Fax |
|
| Email |
icubhu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, AIIMS Rishikesh |
|
|
Primary Sponsor
|
| Name |
AIIMS Rishikesh |
| Address |
AIIMS Rishikesh Virbhadra road Rishikesh Uttarakhand |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gaurav Jain |
OT complex |
Department of Anaesthesiology, Level 6, AIIMS Rishikesh
Dehradun
UTTARANCHAL |
8808631209
icubhu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical Committee, AIIMS, Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
After assessing baseline outcome parameters, postural recruitment maneuver will be performed. The patients will be maintained in supine position for 90 seconds and then turned first to left lateral decubitus position and then to right lateral decubitus position, each for 90 seconds at constant ventilation and positive end expiratory pressure of 10 cm H2O, respectively (time for shifting to particular position: 30 seconds). Thereafter, reverted to supine position. |
| Comparator Agent |
Group B |
After assessing baseline outcome parameters, patients will be maintained in supine position for same duration and ventilatory settings as intervention group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists class I and II, posted for elective laparoscopic cholecystectomy surgery |
|
| ExclusionCriteria |
| Details |
Obesity (Body Mass Index >40 kg/square metre)
History of cardiovascular or respiratory disease
Previous chest surgery
Pregnancy
Patients with contraindication to PEEP initiation such as raised intracranial pressure and hypotension |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Lung atelectasis assessed by ultrasound |
Baseline (5 minutes after general anaesthesia induction), 5 minutes before creating pneumoperitoneum, and just before terminating pneumoperitoneum |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Arterial blood gas parameters including PaO2, PaCO2, pH, HCO3- |
Baseline (5 minutes after general anaesthesia induction), 5minutes before creating pneumoperitoneum, and just before terminating pneumoperitoneum |
| Ventilatory parameters including Ppeak, Pmean, Pplat and tidal volume |
Baseline (5 minutes after general anaesthesia induction), 5 minutes before creating pneumoperitoneum, and just before terminating pneumoperitoneum |
| Duration of surgery |
Intraoperative period |
| Intraoperative complications |
Intraoperative period |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
General anaesthesia leads to lung atelectasis, even in healthy parenchyma. This pathophysiologic alteration is a result of decrease in functional residual capacity and respiratory compliance, due to compression of lung parenchyma by abdominal viscera, especially in dependent areas of lung. The creation of pneumoperitoneum during laparoscopic surgery further augments these changes, leading to increased risk of hypoxemia and pulmonary complications during perioperative period. Mechanical ventilation by-itself is insufficient to offset these compressive effects due to low transpulmonary pressure, especially in gravity-dependent zones of lung. Different approaches have been tried to minimize these changes, including head-up position, application of intraoperative positive end expiratory pressure (PEEP), or recruitment maneuver (RM) etc. The RM has been found to most effective in reverting atelectasis, among all strategies. However, potential hemodynamic complications of high transthoracic pressures by RM require close haemodynamic monitoring of such patients, especially in laparoscopic surgery exposing the patient to detrimental effects of capnoperitoneum. Postural recruitment maneuver (PRM) have been suggested as an effective and efficient low risk alternative to RM in a recent brief communication. Changing the body position while applying PEEP of 10 cmH2O for just 3 min, prevented atelectasis in mechanically ventilated children under general anaesthesia. Our aim is to assess the effects of postural recruitment maneuver and positive end-expiratory pressure on lung atelectasis during laparoscopic cholecystectomy surgery.
|