| CTRI Number |
CTRI/2024/11/076990 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
17/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Changes in Breathing Tube Pressure Between Lying on the Back and Lying Face Down in Patients Having Lower Spine Surgery |
|
Scientific Title of Study
|
A comparison of endotracheal tube cuff pressure changes between supine and prone position in patients undergoing lumbar spine surgery |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divyansh Choudhary |
| Designation |
Post Graduate Resident Doctor |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department Of Anaesthesia and intensive care, Main OT building, Room number 1,
Division 1, Ground floor, Vardhman Mahavir Medical College &
Safdarjung Hospital, New Delhi
South
DELHI
110029
India |
| Phone |
9868568236 |
| Fax |
|
| Email |
divyanshchoudhary8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Panwar |
| Designation |
Professor |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Faculty Room Department of anaesthesia and intensive care
Vardhman Mahavir Medical College and Safdarjung Hospital New
Delhi
South
DELHI
110029
India |
| Phone |
9013000543 |
| Fax |
|
| Email |
drmkumath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Divyansh Choudhary |
| Designation |
Post Graduate Resident Doctor |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department Of Anaesthesia and intensive care, Main OT building, Room number 1,
Division 1, Ground floor, Vardhman Mahavir Medical College &
Safdarjung Hospital, New Delhi
South
DELHI
110029
India |
| Phone |
9868568236 |
| Fax |
|
| Email |
divyanshchoudhary8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and
Safdarjung Hospital New Delhi India 110029 |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Office of the H.O.D. Department of Anaesthesiology and intensive care Vardhman Mahavir Medical College and Safdarjung hospital New Delhi India 110029 |
| 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 Divyansh Choudhary |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department Of Anaesthesia and intensive care, Main OT building, Room number 1,
Division 1, Ground floor, Vardhman Mahavir Medical College &
Safdarjung Hospital, New Delhi
South
DELHI |
9868568236
divyanshchoudhary8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Vardhman Mahavir Medical and Safdarjung Hospital New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M419||Scoliosis, unspecified, (2) ICD-10 Condition: M483||Traumatic spondylopathy, (3) ICD-10 Condition: M485||Collapsed vertebra, not elsewhereclassified, (4) ICD-10 Condition: M472||Other spondylosis with radiculopathy, (5) ICD-10 Condition: M456||Ankylosing spondylitis lumbar region, (6) ICD-10 Condition: M462||Osteomyelitis of vertebra, (7) ICD-10 Condition: M480||Spinal stenosis, (8) ICD-10 Condition: M488||Other specified spondylopathies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged between 18-65 years, ASA status of I and II and Undergoing elective lumbar spine surgery |
|
| ExclusionCriteria |
| Details |
Pregnancy, Difficult Airway, History Of Neck Surgery and Pre-existing history of hoarseness and sore throat |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of supine vs prone position on endotracheal tube cuff pressure in patients undergoing lumbar spine surgery |
After induction in supine position, 5 minutes after proning and 30 minutes thereafter till end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe incidence of post operative sore throat & cough in these patients |
One hour post operative period |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
16/12/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This is an observational study on comparing the changes in endotracheal cuff pressure between the supine and prone positions in patients undergoing lumbar spine surgery. Since positioning can affect airway management, the study investigates whether there are significant differences in cuff pressure, which may influence ventilation safety and prevent complications like airway injury or leakage during surgery. |