| CTRI Number |
CTRI/2024/12/078766 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
30/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of monitoring between exhaled carbon dioxide and carbon dioxide pressure in atrerial blood after extubation to timely detect the extubation failure |
|
Scientific Title of Study
|
Comparison between mainstream end tidal carbon dioxide monitoring v/s arterial pressure of carbon dioxide monitoring post extubation in patients on non invasive ventilation on timely detection of extubation failure. |
| 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 Shirin Parveen |
| Designation |
Associate Professor |
| Affiliation |
Era’s Lucknow Medical College and Hospital |
| Address |
Department of Anaesthesiology Era’s Lucknow Medical College and Hospital Sarfarazganj, Lucknow
Era’s Lucknow Medical College and Hospital Sarfarazganj
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7388732089 |
| Fax |
|
| Email |
shirin-grmc@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhulika Dubey |
| Designation |
Assistant Professor |
| Affiliation |
Era’s Lucknow Medical College and Hospital |
| Address |
Critical Care Unit, Department of Anaesthesiology
Era’s Lucknow Medical College and Hospital, Sarfarazganj
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9899942628 |
| Fax |
|
| Email |
madhulika16sep@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hiba Khan |
| Designation |
Junior Resident |
| Affiliation |
Era’s Lucknow Medical College and Hospital |
| Address |
Department of Anaesthesiology
Era’s Lucknow Medical College and Hospital, Sarfarazganj
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8318152386 |
| Fax |
|
| Email |
khandrhiba@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
None |
| Address |
Not applicable |
| Type of Sponsor |
Other [Not applicable] |
|
|
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 Hiba Khan |
Eras Lucknow Medical College and hospital |
ICU CC, Critical Care Unit , Department of Anaesthesiology
Lucknow
UTTAR PRADESH |
8318152386
khandrhiba@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ELMC&H Era University Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex and who are 18 years of age and above.
Patients who are admitted in ICU.
Patients who are planned for Non Invasive Ventilation after extubation.
Patients who are at high risk of extubation failure. |
|
| ExclusionCriteria |
| Details |
Contraindication for Non Invasive Ventilation therapy.
Tracheostomized patients.
DNI (do not intubate) orders.
Accidental or self extubation.
Patients in whom arterial blood samples cannot be collected. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intubation within 48 hours of extubation. |
Intubation within 48 hours of extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Correlation between ETCO2 and PaCO2.
Comparison of:
-Incidence of sepsis, cardiopulmonary arrest and multiorgan dysfunction.
-Hospital length of stay
-ICU length of stay
-Hospital mortality
-ICU mortality
in between two groups. |
Correlation between ETCO2 and PaCO2.
Comparison of:
-Incidence of sepsis, cardiopulmonary arrest and multiorgan dysfunction.
-Hospital length of stay
-ICU length of stay
-Hospital mortality
-ICU mortality
in between two groups. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/01/2025 |
| 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 study is being done to timely detect extubation failure by comparing mainstream PetCO2 monitoring and standard practice during non invasive ventilation (NIV) after extubation and to correlate arterial blood gas (ABG) with ETCO2 and PaCO2 method. |