FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/05/067020 [Registered on: 08/05/2024] Trial Registered Prospectively
Last Modified On: 10/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To study the effect of Leg compression by air filled device on post anaesthesia decrease in blood pressure in head injury patients undergoing surgery on head to remove bone and decrease pressure by the injured brain 
Scientific Title of Study   Effect of Pneumatic leg Compression on Post Induction hypotension in Adult Patients undergoing decompressive craniotomy surgeries in isolated Traumatic Brain Injury patients: A Randomised 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  VIDUSHI AHLAWAT 
Designation  Junior Resident 
Affiliation  POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH 
Address  Room No. 1, 4th Floor, Department of Anesthesia and intensive Care, Nehru Hospital, PGIMER, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  919538041202  
Fax    
Email  vidushiahlawat02@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  ANKUR LUTHRA 
Designation  Associate Professor 
Affiliation  PGIMER, Chandigarh 
Address  Room No. 1, 4th floor, A-BLOCK, Division of Neuroanaesthesia, Department of Anesthesia and Intensive Care, PGIMER, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  919868057732  
Fax    
Email  zazzydude979@gmail.com  
 
Details of Contact Person
Public Query  
Name  ANKUR LUTHRA 
Designation  Associate Professor 
Affiliation  PGIMER, Chandigarh 
Address  Room No. 1, 4th Floor, A-Block, Division of Neuroanaesthesia, Department of Anesthesia and Intensive Care, Nehru Hospital, PGIMER, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  919868057732  
Fax    
Email  zazzydude979@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia and Intensive Care, PGIMER, Chandigarh, India, 160012 
 
Primary Sponsor  
Name  Ankur Luthra 
Address  Room No. 1, 4th Floor, A-Block, Division of Neuroanaesthesia, Department of Anaesthesia and Intensive Care, PGIMER, Chandigarh, India, 160012 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Ankur Luthra  Room No. 1, 4th Floor, A-Block, Division of Neuroanaesthesia, Department of Anesthesia and Intensive Care, PGIMER, Chandigarh, India - 160012 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR ANKUR LUTHRA  Postgraduate Institute of Medical Education and Research, Chandigarh  Advanced Trauma Centre, 2nd Floor, Department of Anaesthesia and Intensive Care, PGIMER, Chandigarh, India - 160012
Chandigarh
CHANDIGARH 		 9868057732

zazzydude979@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Intramural), Postgraduate Institute of Medical Education and Research, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S062||Diffuse traumatic brain injury,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  No pneumatic compression on the leg  In the control group, the pneumatic compression device will be attached but not switched on.  
Intervention  Pneumatic compression of Leg (calf muscles)  The pneumatic compression device will be attached prior to anaesthesia induction. In all patients of PC Group, the pneumatic compression device will be installed and activated before induction of anesthesia. With a continuous mode timer and a set pressure of 50 mmHg, pneumatic leg compression with progressive sequential compression will be performed, providing 36 seconds of inflation and 24 seconds of deflation throughout the surgery. Incidence of hypotension (Systolic blood pressure 90 mm Hg) will be noted during first 20 minutes after anesthesia induction. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  90 ASA I, II and III patients aged between 18-65 years having isolated severe traumatic brain injury i.e midline shift of ≥5mm and effacement of cisterns in CT scan, scheduled for decompressive craniotomy will be enrolled in this study. 
 
ExclusionCriteria 
Details  Uncontrolled hypertension and coronary artery disease, history of DVT, patient refusal, poor ejection fraction 
 
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 
To compare the incidence of ‘post induction hypotension’ after induction in the patients undergoing “decompressive craniotomy surgery” between the pneumatic and control groups  20 minutes after induction of Anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
• Number of hypotensive episodes in first 20 mins after induction and post decompression craniotomy till end of surgery.  First 20 min after anaesthesia induction and decompressive craniotomy procedure 
Use of vasopressors and, intravenous fluids etc. in first 20 minute and thereafter during surgery.  First 20 minutes after anaesthesia induction and then throughout the duration of surgery 
Arterial blood gas changes between the baseline, 20 minutes post induction and at the end of the surgery in terms of base deficit, lactate and p/f ratio.  Baseline before anaesthesia induction, 20 minutes post induction of anaesthesia and at the end of surgery.  
Observe the incidence of complications/side effects of the use of pneumatic compression device  Every 8 hours till 72 hours post surgery 
 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   20/05/2024 
Date of Study Completion (India) 01/06/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 01/06/2025 
Estimated Duration of Trial   Years="1"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [zazzydude979@gmail.com].

  6. For how long will this data be available start date provided 01-12-2025 and end date provided 01-12-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Pneumatic leg compression which is a simple, non-invasive technique has been shown to reduce the incidence of post-induction hypotension in surgeries like caesarean section (post-spinal anaesthesia) and robot-assisted laparoscopic prostatectomy. Although there is theoretical justification and some initial data in favour of the advantages of pneumatic leg compression, there is still a lack of thorough assessment via randomised controlled trials in the context of decompressive craniotomy surgeries. The purpose of this research is to evaluate the safety and effectiveness of pneumatic leg compression as a strategy to lower Post Induction Hypotension (PIH) and enhance patient outcomes in adult patients having isolated traumatic brain injury undergoing decompressive craniotomy surgery. We hypothesize that using pneumatic leg compression in isolated traumatic brain injury patients undergoing decompressive craniotomy surgeries both prior to and during the induction of general anaesthesia would decrease the incidence of post-induction hypotension, which is defined as systolic arterial pressure (SBP) of less than 90 mmHg at any time point in the first 20 minutes after induction.

 
Close