| CTRI Number |
CTRI/2021/09/036686 [Registered on: 21/09/2021] Trial Registered Prospectively |
| Last Modified On: |
20/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of regular recruitment on atelectasis in prone position during General Anaesthesia |
|
Scientific Title of Study
|
The effect of regular alveolar recruitment on intraoperative atelectasis in patients ventilated in the prone position: A Randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shanti Kumari |
| Designation |
Senior Resident |
| Affiliation |
Indira Gandhi Institute Of Medical Sciences, Sheikhpura, Patna |
| Address |
Department of Anaesthesia
Indira Gandhi Institute Of Medical Sciences, Sheikhpura, Patna
Patna
BIHAR
800014
India |
| Phone |
8581869609 |
| Fax |
|
| Email |
kavitashanti2010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shanti Kumari |
| Designation |
Senior Resident |
| Affiliation |
Indira Gandhi Institute Of Medical Sciences, Sheikhpura, Patna |
| Address |
Department of Anaesthesia
Indira Gandhi Institute Of Medical Sciences, Sheikhpura, Patna
Patna
BIHAR
800014
India |
| Phone |
8581869609 |
| Fax |
|
| Email |
kavitashanti2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shanti Kumari |
| Designation |
Senior Resident |
| Affiliation |
Indira Gandhi Institute Of Medical Sciences, Sheikhpura, Patna |
| Address |
Department of Anaesthesia
Indira Gandhi Institute Of Medical Sciences, Sheikhpura, Patna
Patna
BIHAR
800014
India |
| Phone |
8581869609 |
| Fax |
|
| Email |
kavitashanti2010@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Institute of Medical Sciences |
| Address |
Sheikhpur, Patna, Bihar,India
Pin: 800014 |
| 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 Shanti Kumari |
OT Complex, 1st Floor,Department of Anaesthesia |
Indira Gandhi Institute Of Medical Sciences, Sheikhpura, Patna
Patna
BIHAR |
8581869609
kavitashanti2010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, IGIMS, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
No Alveolar Recruitment In Control Group |
Control Group will not receive regular recruitment i.e. every hourly intraopratively. Lung scan will be done to evaluate to assess the degree of atelectasis at three occasions (Baseline supine, Baseline Prone, Preextubation) |
| Comparator Agent |
Regular alveolar recruitment |
Regular alveolar recruitment will be done every hourly and lung scan will be done to evaluate its impact on atelectasis. Lung scan will be done at three occasions (Baseline supine, Baseline Prone, Preextubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The study will be carried out on consenting ASA physical status I & II patients of either sex scheduled to undergo elective noncardiac surgery in the prone position under general anaesthesia (>2 h) requiring tracheal intubation and mechanical ventilation. |
|
| ExclusionCriteria |
| Details |
After routine preoperative evaluation and investigation, the following patients will be excluded from the study; Patients with previous thoracic surgery, pulmonary disease, airway anomaly, airway infection, and abnormal preoperative chest X-ray findings, such as atelectasis, pneumothorax, pleural effusion, or pneumonia. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
the effect of regular recruitment vs single alveolar recruitment, in preventing atelectasis in adult patients after general anaesthesia in the prone position using lung ultrasound.
|
the effect of regular recruitment vs single alveolar recruitment, in preventing atelectasis in adult patients after general anaesthesia in the prone position using lung ultrasound. Lung ultrasonography will be done just after making prone and at the end of surgery
|
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
25/09/2021 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We propose to evaluate and compare the effect of regular recruitment vs single alveolar recruitment, in preventing atelectasis in adult patients after general anaesthesia in prone position using lung ultrasound |