FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/03/063974 [Registered on: 11/03/2024] Trial Registered Prospectively
Last Modified On: 07/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   prospective comparative study 
Study Design  Other 
Public Title of Study   change in endotracheal tube cuff pressure after genaral anaesthesia in supine and prone position. 
Scientific Title of Study   A Comparative study of endotracheal tube cuff pressure changes in supine vs prone position in neurosurgical patients using air and oxygen as anaesthetic gas mixture” 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shrikanta Oak 
Designation  Professor (Additional) 
Affiliation  Seth G S Medical College and KEM Hospital 
Address  Room No.139 , Department of Anaesthesia,First floor, OLD Building, KEM Hospital, Ernest Borges Marg ,Parel 12

Mumbai
MAHARASHTRA
400066
India 
Phone  9324134023  
Fax    
Email  shrikanta_oak@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shrikanta Oak 
Designation  Professor (Additional) 
Affiliation  Seth G S Medical College and KEM Hospital 
Address  Room No.139 , Department of Anaesthesia,First floor, OLD Building, KEM Hospital, Ernest Borges Marg ,Parel 12

Mumbai
MAHARASHTRA
400066
India 
Phone  9324134023  
Fax    
Email  shrikanta_oak@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr naresh kumar Kushwah 
Designation  junior Resident 2 
Affiliation  Seth G S Medical College and KEM Hospital 
Address  Room No 315, ANEX Hostel, Near Monorail Station, KEM Hospital, MUMBAI

Mumbai
MAHARASHTRA
400066
India 
Phone  9039812076  
Fax    
Email  kushwahnaresh92@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia,GSMC and KEM Hospital  
 
Primary Sponsor  
Name  Seth G S Medical college and KEM Hospital 
Address  KEM Hospital, PAREL, MUMBAI,MAHARASHTRA 400066 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr shrikanta Oak  GSMC and KEM Hospital, Mumbai, INDIA  Department of Anaesthesiology, Room No.139, Neurosurgery operation Theatre 400066, Mumbai, Maharashtra
Mumbai
MAHARASHTRA 		 9324134023

shrikanta_oak@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee(IEC)-III ,relating to biomedical and health Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: G89-G99||Other disorders of the nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  study of change of endotracheal tube cuff pressure in supine and prone position in neurosurgical patient using ET Tube cuff manometer while using oxygen and air as an anaesthetic gas mixture.  Patient is intubated with ET Tube under general anaesthesia .The ET tube cuff pressure will be checked with ET Tube cuff manometer and pressure volume loop completion also checked and reading recorded . cuff pressure adjusted with in 20 to 30 cm H2o.The cuff pressure will be checked and adjusted again after achieving the final position, At the end of procedure and Before extubation. at every time pressure volume loop completion and Time will be recorded.The volume of Air required to inflate or deflate the ET tube cuff will be recorded using 2cc syringe. This study done whole intraoperativally ,plus patient is also followed for 24 hour post operativally for sore throat. total duration of study is 15 month.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients whose age group is between 18 and 65years.
ASA grade 1 & ASA grade 2 patients.
Elective neurosurgical patients whose surgical. position is either supine or prone in genaral anaesthesia.  
 
ExclusionCriteria 
Details  pregnant pateint
emergency cases
history of urti/lrti with in last 15 days
pateint with thyroid swelling,tracheal pathologies 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the Endotracheal tube cuff pressure changes in supine and prone position in neurosurgical patients.   After intubation, After final position, At the end of procedure, Before extubation. 
 
Secondary Outcome  
Outcome  TimePoints 
1.Incidence of change in endotracheal tube cuff volume required to keep the endotracheal cuff pressure with in the allowable limit (20 to 30 cm of H2O)
2.The post operative incidence of sore throat 		 After intubation, After final position, At the end of procedure, Before extubation.

Ask for Post operative sore throat at 2hour,6hour,24hours  
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   20/03/2024 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - 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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  personal email id .. shrikanta_oak@yahoo.com

  6. For how long will this data be available start date provided 11-03-2024 and end date provided 11-04-2036?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Main function of Endotracheal tube(ET tube)cuff is maintain adequate sealing of airway to gastropharyngeal  aspiration & ensure the effective lung ventilation. Cuffed ET tube become the standard care for providing general anaesthesia because of better seal of trachea. Pressure inside the cuff should be good enough to prevent aspiration but not too high to obstruct the tracheal mucosa blood flow, it can also cause post op sore throat, hoarseness of voice and dysphagia. It is recommended that ET tube  cuff pressure should be maintained between 20 t0 30 cm of H2O. This study will compare the ET tube cuff pressure changes in supine or prone position in neurosurgical pateints while using oxygen & air as anaesthetic gas mixture. The cuff pressure will be  checked and adjusted at different interval of time  (After intubation, After final position, After procedure and Before extubation. Pressure volume loop completion  is also checked  at everytime. The volume of air required to inflate of deflate the ET tube cuff will also be recorded using 2cc syringe. post operatively patient is follow up for sore throat in 2 hours, 6 hours, 24 hours.
Primary aim of study  is to compare effect of positions(Supine and prone) on ET tube cuff pressure in neurosurgery pateints.
Secondary aim is incidence of change in ET tube  cuff volume required to keep the ET tube cuff pressure with in the allowable limit (20 to 30 cm of H2O) and to find out incidence of post operative sore Throat.

 
Close