| CTRI Number |
CTRI/2022/04/042130 [Registered on: 25/04/2022] Trial Registered Prospectively |
| Last Modified On: |
30/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE |
| Study Design |
Other |
|
Public Title of Study
|
Study of Alteration in Cuff Pressure Position, Ventilator Mode or Time. |
|
Scientific Title of Study
|
A Prospective Observational Study of Tracheal Tube Cuff Pressure Variation with Position, Time and Mode of Ventilation in Intensive Care Unit |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajswee Rana |
| Designation |
Junior Resident, Dept of Anaesthesiology |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Room No: 016129, Dept of Anaesthesiology, All India Institute of Medical Sciences, Virbhadra road, 249203, Rishikesh, Dehradun, Uttaranchal
Room No: 016129, Dept of Anaesthesiology, All India Institute of Medical Sciences, Virbhadra road, 249203, Rishikesh, Dehradun, Uttaranchal
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8013860031 |
| Fax |
|
| Email |
rrajswee@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankit Agarwal |
| Designation |
Additional Professor, Dept. of Anaesthesiology |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
All India Institute of Medical Sciences, Virbhadra road, 249203, Rishikesh, Dehradun, Uttaranchal
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8475000280 |
| Fax |
|
| Email |
ankit.anaes@aiimsrishikesh.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajswee Rana |
| Designation |
Junior Resident, Dept of Anaesthesiology |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Room No: 016129, Dept of Anaesthesiology, All India Institute of Medical Sciences, Virbhadra road, 249203, Rishikesh, Dehradun, Uttaranchal
Room No: 016129, Dept of Anaesthesiology, All India Institute of Medical Sciences, Virbhadra road, 249203, Rishikesh, Dehradun, Uttaranchal
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8013860031 |
| Fax |
|
| Email |
rrajswee@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS RISHIKESH |
| Address |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, VIRBHADRA ROAD, 249203, RISHIKESH, DEHRADUN, UTTARANCHAL |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rajswee Rana |
All India Institute of Medical Sciences, Rishikesh |
Room No: 016129, Dept of Anaesthesiology, All India Institute of Medical Sciences, Virbhadra road, 249203, Rishikesh, Dehradun, Uttaranchal
Dehradun
UTTARANCHAL |
8013860031
rrajswee@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R092||Respiratory arrest, (2) ICD-10 Condition: R198||Other specified symptoms and signsinvolving the digestive system and abdomen, (3) ICD-10 Condition: R298||Other symptoms and signs involvingthe nervous and musculoskeletal systems, (4) ICD-10 Condition: R398||Other symptoms and signs involvingthe genitourinary system, (5) ICD-10 Condition: E078||Other specified disorders of thyroid, (6) ICD-10 Condition: E139||Other specified diabetes mellituswithout complications, (7) ICD-10 Condition: E878||Other disorders of electrolyte andfluid balance, not elsewhere classified, (8) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, (9) ICD-10 Condition: J969||Respiratory failure, unspecified, (10) ICD-10 Condition: R688||Other general symptoms and signs, |
|
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Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age>18 years and <65 years.
2. American Society of Anesthesiologists (ASA) grading I-IV.
3. Patients admitted in the Critical Care Unit of AIIMS, Rishikesh with either ETT or TT already in place or during subsequent course of stay.
|
|
| ExclusionCriteria |
| Details |
1. Pre-existing chronic cardio-respiratory disease.
2. Obesity (BMI>30 kg/m2).
3. Pregnant and breastfeeding.
4. Refusal for consent.
5. Airway anatomical malformations.
6. Limited neck movement or neck mass.
7. Raised intra-abdominal pressure.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the variation in the cuff pressure of tracheal tube in ICU patients with mode of ventilation. |
8 HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the variation in the cuff pressure of tracheal tube in ICU patients with position.
2. To evaluate the variation in the cuff pressure of tracheal tube in ICU patients with time.
3. To evaluate the change in cuff pressure amongst Endotracheal tube and Tracheostomy tube in ICU patients with respect to above parameters.
|
8 HOURS |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/05/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/05/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective observational study comapring the variation in the tracheal tube cuff pressure with the change in mode of ventilation, position and duration in ICU. Patients either on ETT/
Tracheostomised will be placed on T-piece for the first four hours and then
under PSV for the next four hours.The position of the patients on
ETT with T-piece/PSV or Tracheostomised with T-piece/PSV will be changed from
supine to non-supine or vice versa 2nd houly hourly.The cuff pressure will be
recorded with a digital cuff manometer (AG- cuffill) at the starting of one
position, at 2nd hour in the same position and immediately after the change in
position
|