| CTRI Number |
CTRI/2022/04/042248 [Registered on: 28/04/2022] Trial Registered Prospectively |
| Last Modified On: |
01/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare physiological changes induced by two methods of prone positioning for lumar spine surgery - Wilsons frame and horizontal bolsters |
|
Scientific Title of Study
|
A comparison of physiological changes by prone position over Wilson’s frame and Horizontal Bolsters in Lumbar spine surgery – A randomized prospective 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 Shubham Khandelwal |
| Designation |
Assistant Professor |
| Affiliation |
Mahatma Gandhi Medical College and hospital |
| Address |
Department of Neuro-Anaesthesiology, Fourth floor, Sri Ram Cancer Centre, Mahatma Gandhi Medical College and Hospital, Sitapura, Jaipur
Jaipur
RAJASTHAN
302021
India |
| Phone |
9799052551 |
| Fax |
|
| Email |
shubham.kh29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shubham Khandelwal |
| Designation |
Assistant Professor |
| Affiliation |
Mahatma Gandhi Medical College and hospital |
| Address |
Department of Neuro-Anaesthesiology, Fourth floor, Sri Ram Cancer Centre, Mahatma Gandhi Medical College and Hospital, Sitapura, Jaipur
Jaipur
RAJASTHAN
302021
India |
| Phone |
9799052551 |
| Fax |
|
| Email |
shubham.kh29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubhina Gupta |
| Designation |
Junior Resident |
| Affiliation |
Mahatma Gandhi Medical College and hospital |
| Address |
Department of Anesthesiology, Second floor, Mahatma Gandhi Medical College and Hospital, Sitapura, Jaipur
Jaipur
RAJASTHAN
302021
India |
| Phone |
8308587092 |
| Fax |
|
| Email |
shubhina1492@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical College and Hospital, Sitapura, Jaipur |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College and Hospital |
| Address |
RIICO industrial area, Sitapura, Jaipur |
| Type of Sponsor |
Private 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 Shubham Khandelwal |
Mahatma Gandhi Medical College and Hospital |
Neurosurical operation theatres, Department of Neuro-Anesthesiology, Fourth floor, Sri Ram Cancer Centre, Mahatma Gandhi Medical College and Hospital,RIICO indistrial area Sitapura, Jaipur
Jaipur
RAJASTHAN |
9799052551
shubham.kh29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Etthics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Horizontal bolsters |
A pressure monitoring apparatus is connected on the indwelling foleys catheter when intra-abdominal pressure has to be measured at three different time frames after patient is positioned prone on horizontal bolsters.
Respiratory airway pressures readings are noted from the ventilator.
Blood loss during surgery in quantified through suction apparatus and blood soaked pads. |
| Intervention |
To measure intra-abdominal pressure, respiratory airway pressures and blood loss in prone posiiton |
To measure intra-abdominal pressure, respiratory airway pressures and blood loss in prone position on two most commonly used techniques- Horizontal bolsters and Wilsons frame
Frequency of measurement of parameters-
Time 1) In supine position
Time 2) 10 minutes after turning patient prone
Time 3) Just before turning patient supine from prone
|
| Comparator Agent |
Wilsons frame |
A pressure monitoring apparatus is connected on the indwelling foleys catheter when intra-abdominal pressure has to be measured at three different time frames after patient is positioned prone on Wilsons frame.
Respiratory airway pressures readings are noted from the ventilator.
Blood loss during surgery in quantified through suction apparatus and blood soaked pads. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists Category I and II |
|
| ExclusionCriteria |
| Details |
Patients having-
1)Hypertension
2)Diabetes
3)Renal derangement
4)Hepatic Derangement |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure intra-abdominal pressure at three time points |
1) In supine position
2) 10 minutes after turning the patient prone
3) Just before turning the patient supine from prone |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To measure Peak pressure , Pleateau pressure and intraoperative blood loss in both supine and prone position |
1)Supine position
2)10 minutes after turning the patient prone
3) Before turning supine again |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/05/2022 |
| Date of Study Completion (India) |
01/10/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Prone positioning involves balancing surgical comfort, against the risks related to the patient position. There is a paucity of information on effect of prone position on intra-abdominal pressure, blood loss and how these changes correlate with respiratory airway pressures. This study is conducted to compare two most common methods of prone positioning i.e horizontal bolsters and wilson’s frame to find a better technique for intra-operative optimization of patient. |