| CTRI Number |
CTRI/2021/07/034902 [Registered on: 15/07/2021] Trial Registered Prospectively |
| Last Modified On: |
04/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Effect of positive pressure ventilation at end of expiration on non invasive technique of intracranial pressure monitoring in patients undergoing spine surgery under general anaesthesia |
|
Scientific Title of Study
|
A study to evaluate the effect of positive end-expiratory pressure on optic nerve sheath diameter in spine surgeries done in prone position |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dimpy Saikia |
| Designation |
Junior Resident |
| Affiliation |
Department of Anaesthesiology and Critical Care,Jawaharlal Nehru Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh
Medical road, Aligarh, Uttar Pradesh - 202002
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7002033540 |
| Fax |
|
| Email |
mandrrakes@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shahla Haleem |
| Designation |
Professor |
| Affiliation |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital, Aligarh
Medical Road, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9997448172 |
| Fax |
|
| Email |
shahlahaleem@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Shahla Haleem |
| Designation |
Professor |
| Affiliation |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital, Aligarh
Medical Road, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9997448172 |
| Fax |
|
| Email |
shahlahaleem@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology and Critical Care,JNMCH, Aligarh |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology and Critical Care JNMCH AMU Aligarh |
| Address |
Department of Anaesthesiology and Critical Care,Jawaharlal Nehru Medical College and Hospital |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Abu Nadeem |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital |
| Raman Mohan Sharma |
Department of Neurosurgery, Jawaharlal Nehru Medical College and Hospital |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dimpy Saikia |
Department of Anaesthesiology and Critical Care, JNMCH |
Department of Anesthesiology and Critical Care,Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University
Aligarh
UTTAR PRADESH |
7002033540
mandrrakes@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M480||Spinal stenosis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Written and informed consent
Patients scheduled for elective spine surgery in prone position requiring tracheal intubation
Patients with ASA grade 1 and 2 |
|
| ExclusionCriteria |
| Details |
Patient refusal
Optic nerve diseases
Orbital inury, mass or previous ocular surgery
History of intracranial hypertension
History of respiratory dysfunction
History of thyroid disorder, hypotension,neuropsychiatric disorder
Pregnancy/lactation |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of positive end-expiratory pressure on optic nerve sheath diameter in patients undergoing spine surgeries in prone position |
After 10 minutes of endotracheal intubation in supine position without positive end-expiratory pressure
After 10 minutes of prone position without positive end-expiratory pressure
After 10 minutes of prone position with 3 cm water of positive end-expiratory pressure
After 10 minutes of prone position with 5 cm water of positive end-expiratory pressure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the effect of positive end-expiratory pressure on mean arterial pressure |
After 10 minutes of endotracheal intubation in supine position without positive end-expiratory pressure
After 10 minutes of prone position without positive end-expiratory pressure
After 10 minutes of ventilation with 3 cm water of positive end-expiratory pressure
After 10 minutes of ventilation with 5 cm water of positive end-expiratory pressure |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
21/07/2021 |
| 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="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
TITLE - A prospective observational study to evaluate the effect of positive end-expiratory pressure on optic nerve sheath diameter in spine surgeries done in prone position INTRODUCTION - Mechanical ventilation in prone position and positive end-expiratory pressure are techniques used to improve oxygenation in patients with respiratory failure. However, both prone positioning and positive end-expiratory pressure can have undesirable effects on cerebral physiology and increase the intracranial pressure. In this study, we use optic nerve sheath diameter as a technique to monitor the intracranial pressure. Thus, this study will evaluate the effect of various levels of positive end-expiratory pressure on optic nerve sheath diameter in patients undergoing spine surgeries in prone position |