| CTRI Number |
CTRI/2024/03/064676 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Incremental ] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To compare the difference between fixed and increased positive end expiratory pressure on lung compliance in adults patients undergoing surgery under general anaesthesia. |
|
Scientific Title of Study
|
Effect of fixed versus incremental positive end expiratory pressure on intraoperative lung compliance in adult patients undergoing surgery under general anaesthesia : A randomized controlled trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankita Dey |
| Designation |
Post graduate resident |
| Affiliation |
AIIMS Bathinda |
| Address |
Department of Anaesthesiology and critical care,AIIMS Bathinda,Mandi Dabwali Road,Bathinda
Bathinda PUNJAB 151001 India |
| Phone |
9101797504 |
| Fax |
|
| Email |
ankitadey490@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Jyoti Sharma |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences ,Bathinda |
| Address |
Department of Anaesthesiology and Critical Care,room no.140, AIIMS Bathinda, Mandi Dabwali Road,Bathinda,Punjab
Bathinda PUNJAB 151001 India |
| Phone |
9968583915 |
| Fax |
|
| Email |
doctorjyotisharma@yahoo.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Gopal Krishan Jalwal |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences ,Bathinda |
| Address |
Department of Anaesthesiology and Critical Care,room no.143,AIIMS Bathinda,Mandi Dabwali Road,Bathinda,Punjab
Bathinda PUNJAB 151001 India |
| Phone |
7838939833 |
| Fax |
|
| Email |
gopaljalwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesiology and Critical Care,All India Institute of Medical sciences, Bathinda,Mandi Dabwali road,PIN-151001,Punjab |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical sciences, AIIMS Bathinda |
| Address |
All India Institute of Medical sciences, AIIMS Bathinda |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ankita Dey |
All India Institute of Medical sciences Bathinda |
Department of Anesthesiology and Critical Care, All India Institute of Medical sciences Bathinda,Mandi-Dabwali Road, PIN-151001,Punjab Bathinda PUNJAB |
9101797504
ankitadey490@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C179||Malignant neoplasm of small intestine, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A-Fixed PEEP |
Fixed PEEP of 5cm H2O will be kept throughout the surgery.Static lung compliance will be calculated at every 15min interval starting from induction till 45min. |
| Intervention |
Group B-Incremental PEEP |
Incremental PEEP of 5,7,9cm H2O will be applied at every 15min interval and static lung compliance will be calculated at each step. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing surgery under general anaesthesia with an anticipated surgical duration
≥120minutes.
2. Adult patients aged between 18-65years.
3. ASA physical status I to III patients.
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal of consent.
2. Patients with history of any lung pathology.
3. Patients undergoing neurosurgeries
4. Pregnant patients.
5. Patients already on mechanical ventilation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the difference between fixed and incremental PEEP on intraoperative static lung compliance in adult patients undergoing surgery under general anaesthesia |
Static lung compliance will be calculated at 3 time points at every 15minutes starting from induction. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate immediate post operative pulmonary complications assessed by ultrasonography in adult patients undergoing surgery under general anaesthesia with fixed or incremental PEEP. |
At two time points:1 hour after extubation and 24 hours after extubation. |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| Date of Study Completion (India) |
15/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/08/2025 |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
After enrollment, the patients will be shifted to operation theatre and placed in supine position. Standard ASA monitors will be attached. Baseline parameters such as heart rate(HR),systolic blood pressure(SBP), and diastolic blood pressure(DBP), mean arterial pressure (MAP),oxygen saturation (SpO2)will be noted. A wide bore intravenous (IV) cannula will be inserted. Following preoxygenation for 3minutes, induction of anaesthesia will be done with injection midazolam (0.02mg/kg), Propofol(2-2.5mg/kg) and Fentanyl(2mcg/kg). After checking the ability to ventilate, Vecuronium (0.1mg/kg) will be administered as a muscle relaxant following which patients will be manually ventilated for 3 minutes. Laryngoscopy will be performed using appropriate size laryngoscopy blade. Endotracheal intubation will be done using appropriate size tube and the airway will be secured. After intubation, general anaesthesia will be maintained with oxygen & air (50:50), isoflurane (Minimum alveolar concentration 1.0). All patients will be ventilated using a closed circuit with the ventilator setting being volumecontrolled mechanical ventilation, with 6-8ml/kg tidal volume, fraction of inspired oxygen 50%, inspiratory: expiratory ratio will be 1:2, and respiratory rate will be adjusted to maintain an end-tidal carbon dioxide of 30-35 mmHg. Normothermia will be maintained throughout the surgery. In Group A, a fixed PEEP of 5cm H2O will be delivered throughout the procedure. Static lung compliance will be calculated at three points with 15 minutes interval starting from induction. In Group B, incremental PEEP of 5,7 and 9 cm H2O will be delivered at every 15 minutes interval and static lung compliance will be measured at each step keeping Pplat<30 .(16) Static lung compliance (Cs) can be calculated as follows(15): Cs=Vt/(Pplat-PEEP) Where Vt is the Tidal volume. Pplat is the plateau pressure. Pplat is measured at the end of inspiration by holding the inspiration for few seconds. PEEP will be decreased gradually from 9 cm H2O over the next 15 minutes and a PEEP of 5 cm H2O will be maintained throughout the procedure after that. Fluids will be given as required and amount and type of fluid will be noted. Any episode of acute hypotension during the study will be treated with Inj. Mephentermine 6mg I/V. At the end of the procedure, reversal of neuromuscular blockade will be done using Inj. Neostigmine 0.03-0.07mg/kg with Inj.Glycopyrrolate 0.01mcg/kg. Extubation will be done only after full reversal of neuromuscular blockade with a TOF ratio of more than 0.9 and the patient following verbal commands and ventilating spontaneously. After extubation, the patient will be shifted to postoperative area. Any episode of desaturation (SpO2<92%) will be treated with oxygen supplementation. The patients will be observed for immediate postoperative pulmonary complications using lung ultrasound at two time points:1 hour after extubation(T1) and 24 hours after extubation(T2). Low frequency curvilinear (2-5 MHz) probe of the SonoSite Fujifilm Edge II inc.USA Ultrasound System will be used for lung ultrasound scanning. Each side of the thorax will be divided into six zones by two vertical (anterior and posterior axillary lines) and one imaginary horizontal line (passing above the nipple), so a total of 12 lung areas will be scanned. Intercostal spaces of each of these areas will be scanned, and an image of the most pathologic area of each quadrant will be saved to digital format for offline analysis and scoring. The scoring of lung ultrasound will be done according to a modified lung ultrasound scoring (mLUS) system.(9) According to the mLUS system, Score 0: A-line profile or up to two B-line separated by regular pleural lines. Score 1: if there are three or more B-lines with or without small subpleural consolidation and a regular pleural line. Score 2: if there are coalescent B-lines and or small subpleural consolidation with an irregular pleural line in between. Score 3: if extensive subpleural consolidation is more than 1x2 cm. Detailed ultrasound Based upon the mLUS scoring system, each area was scored from 0-3, so a minimum zero or maximum 36 score is possible. Lung ultrasound will be performed at two predefined time points, 1hour after extubation and 24hours after extubation of the trachea. |