CTRI Number |
CTRI/2018/07/014954 [Registered on: 18/07/2018] Trial Registered Prospectively |
Last Modified On: |
09/08/2020 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
To find out effect of lung exansion method on lung collapse (A common problem i all the patient who undergo gall bladder sugery through laparoscopy) with the help of ultrasound in the patient who are undergoing gall bladder surgery through laparoscopic method. |
Scientific Title of Study
|
Point of care ultrasonography to evaluate the effect of pre-extubation lung recruitment maneuver on perioperative atelectasis in patients undergoing laparoscopic cholecystectomy |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DEVENDRA GUPTA |
Designation |
Professor |
Affiliation |
SGPGIMS, LUCKNOW (INDIA0 |
Address |
Department of Anaesthesiology, Lucknow. Department of Anaesthesiology, Lucknow. Lucknow UTTAR PRADESH 226014 India |
Phone |
8004904596 |
Fax |
05222668017 |
Email |
drdevendragpt@yahoo.com |
|
Details of Contact Person Scientific Query
|
Name |
DEVENDRA GUPTA |
Designation |
Professor |
Affiliation |
SGPGIMS, LUCKNOW (INDIA0 |
Address |
Department of Anaesthesiology, Lucknow. Department of Anaesthesiology, Lucknow. Lucknow UTTAR PRADESH 226014 India |
Phone |
8004904596 |
Fax |
05222668017 |
Email |
drdevendragpt@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr Nitin Gupta |
Designation |
MD student |
Affiliation |
SGPGIMS, LUCKNOW (INDIA0 |
Address |
Department of Anaesthesiology, Lucknow. Department of Anaesthesiology, Lucknow. Lucknow UTTAR PRADESH 226014 India |
Phone |
8004904609 |
Fax |
05222668017 |
Email |
drnitin1983@gmail.com |
|
Source of Monetary or Material Support
|
Department of Anaesthesiology, SGPGIMS, Lucknow |
|
Primary Sponsor
|
Name |
SANJAY GANDHI POSTGRADUATE INSTITUTE OF MEDICAL SCIENCES LUCKNOW |
Address |
Department of Anaesthesiology, SGPGIMS, Lucknow |
Type of Sponsor |
Research institution |
|
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 Devendra Gupta |
Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow |
Department of Anaesthesiology (BLOCK A)
SGPGIMS Lucknow UTTAR PRADESH |
8004904596 05222668017 drdevendragpt@yahoo.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, Patient undergoing laparoscopic cholecystectomy, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Alveolar recruitment group 10 (group III): |
PEEP of 10 cm of H2O will be applied 10 min before extuation and will be maintained till extubation. |
Intervention |
Alveolar recruitment group 5 (group II): |
PEEP of 5 cm of H2O will be applied 10 min before extuation and will be maintained till extubation |
Comparator Agent |
Control |
No application of PEEP or alveolar recruitment before extubation. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Patients of age of 18 to 60 years , of either sex, belonging to ASA physical status of I and II undergoing laparoscopic cholecystectomy surgery under General anesthesia. |
|
ExclusionCriteria |
Details |
Patient with morbid obesity, history of smoking or chronic respiratory disease, bronchial asthma, cardiac, pulmonary, renal or neuromuscular disorders, contraindication of laparoscopic surgery and patient with history of previous abdominal surgery will be excluded from this study |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
the effect of different lung recruitment maneuvers on modified lung ultrasound score. |
Images will be obtained at 5 predefined time points: before GA induction (time point A), 5 minutes after GA induction (time point B), after pneumoperitoneum and before recruitment maneuver (time point C), 10 minutes after the arrival of patients in the recovery room (time point D), and 60 minutes after the arrival of patients in the recovery room or immediately before the discharge from the recovery room (time point E). |
|
Secondary Outcome
|
Outcome |
TimePoints |
Postoperative complications and pain score |
Immediate postoperative period and at the time of discharge from postoperative ward |
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
|
18/07/2018 |
Date of Study Completion (India) |
30/10/2017 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
No publication of such study nor registered so far any clinical trial registry |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Objective: Pneumoperitoneum resulted into alteration in gas exchange is due to intraoperative atelectasis resulting in collapse of alveoli and increase in resistance of airways which leads to intrapulmonary shunting, ventilation perfusion mismatch and ultimately arterial hypoxemia. In a recent pilot study on the model of laparoscopic surgery-induced atelectasis demonstrated the feasibility of lung ultrasonography during the perioperative period. Lung ultrasonography also allowed the tracking of perioperative atelectasis and facilitates the diagnosis of respiratory complications. Studies demonstrated that in patients undergoing laparoscopic cholecystectomy, the open lung approach was suitable for bedside PEEP setting, improved lung mechanics and gas exchange without significant adverse hemodynamic effects. We therefore planned a study to evaluate effect of different lung maneuver on modified lung ultrasound score with the use of point of care lung ultrasound during laparoscopic cholecystectomy. Methods This prospective randomized double blind controlled study will be conducted in patients of age of 18 to 60 years , of either sex , belonging to ASA physical status of I and II undergoing laparoscopic cholecystectomy surgery under GA. Patient with morbid obesity, history of smoking or chronic respiratory disease, bronchial asthma, cardiac, pulmonary, renal or neuromuscular disorders, contraindication of laparoscopic surgery and patient with history of previous abdominal surgery will be excluded from this study All patients will be given anesthesia as per departmental protocol. Tidal volume will be set at 8ml/kg of predicted body weight, FiO2 0.40, respiratory rate of 12 / minute adjusted to obtain an end tidal carbon dioxide 35+ 2, inspiratory to expiratory ratio of 1:2, and no positive end-expiratory pressure (PEEP). Pneumoperitoneum during laparoscopic cholecysytecomy will be maintained with co2 insufflated in abdomen to pressure of 15 mm of Hg. Depending upon the computer generated random number patient has been assigned the any of the three groups. In control group (group I): No application of PEEP or alveolar recruitment before extubation. In Alveolar recruitment group 5 (group II): PEEP of 5 cm of H2O will be applied 10 min before extubation and will be maintained till extubation. Alveolar recruitment group 10 (group III): PEEP of 10 cm of H2O will be applied 10 min before extubation and will be maintained till extubation. For safety reason, working pressure of ventilator will be limited to 30cm of H2O. PEEP will be increased to desired level after obtaining the information of hemodynamic state of the individual patient. Lung ultrasonography will be performed by 2 trained echographists (DG and RV respectively, with 10 years and 3 years of experience in lung ultrasonography) using a convex array 2- to 5-MHz transducer. Aeration loss will be assessed by calculating the modified LUS score in each of the 12 quadrants. Images will be obtained at 5 predefined time points: before GA induction (time point A), 5 minutes after GA induction (time point B), after pneumoperitoneum and before recruitment maneuver (time point C), 10 minutes after the arrival of patients in the recovery room (time point D), and 60 minutes after the arrival of patients in the recovery room or immediately before the discharge from the recovery room (time point E). Care will be taken to set the focal zone on the pleural line. No second harmonic imaging will be used. Thorax will be divided into 12 quadrants (Figure 1): anterior, lateral, and posterior zones (separated by the anterior and posterior axillary lines) each divided in upper and lower portions for the right and left lung. Intercostal spaces of each of these areas will be scanned and a cine-loop of the most pathologic area of each quadrant will be saved to digital format for offline analysis. Primary outcome will be the effect of different lung recruitment maneuvers on modified lung ultrasound score. Secondary outcome will be postoperative complications and pain score. To test the effect of different lung recruitment maneuvers on modified LUS, sample size will be taken 30 patients in each of the three study groups with total of 90 patients. |