| CTRI Number |
CTRI/2024/02/062564 [Registered on: 13/02/2024] Trial Registered Prospectively |
| Last Modified On: |
10/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Comparison between different modalities of oxygen support after extubation in critically ill patients who are at high risk of extubation failure |
|
Scientific Title of Study
|
Comparison of effects of post extubation non invasive ventilation with passive humidification and high flow nasal canula in patients with high risk 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 |
Nimisha patil |
| Designation |
Junior resident in Anaesthesia department |
| Affiliation |
Era lucknow medical college and hospital |
| Address |
Department of Anaesthesiology Era medical college and hospital sarfarazganj lucknow
Era lucknow medical college and hospital sarfarazganj lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8595293873 |
| Fax |
|
| Email |
nimi2311patil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishna Pratap Mall |
| Designation |
Professor Department of Anaesthesiology |
| Affiliation |
Era Lucknow Medical college and hospital |
| Address |
Department Of Aneasthesiology 2nd floor Era lucknow medical college and hospital sarfarazganj lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9140283488 |
| Fax |
|
| Email |
Dr_mall_79@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nimisha Sudhir Patil |
| Designation |
Junior Resident Department of Anaesthesia |
| Affiliation |
Era Lucknow medical college and hospital |
| Address |
Era lucknow medical college and hospital sarfarazganj lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8860574386 |
| Fax |
|
| Email |
nimi2311patil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesiology ERA LUCKNOW MEDICAL COLLEGE AND HOSPITAL SARFARJGANJ, LUCKNOW 226003 |
|
|
Primary Sponsor
|
| Name |
Era lucknow medical college and hospital |
| Address |
Era lucknow medical college and hospital Srfarazganj lucknow UP 226003 |
| Type of Sponsor |
Private 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 Krishna Pratap Mall |
Era lucknow medical college and hospital |
Department of anesthesiology Era lucknow medical college and hospital sarfarazganj
Lucknow
UTTAR PRADESH |
9140283488
Dr_mall_79@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Reg No ECR/717/Inst/UP/2015/RR-21 ELMCH and 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
|
| Type |
Name |
Details |
| Intervention |
High flow nasal canula |
High flow nasal cannula will be applied for 48hrs in patients who are at high risk of extubation failure
Fraction of inspired oxygen shall
be adjusted to maintain spo2 more than92%
Vital signs and arterial blood gas analysis will be measured at 1hr 24 hr and 48hr |
| Comparator Agent |
Non invasive ventilation with passive humidification |
Non-invasive ventilation (NIV) will be applied in patients who are at high risk of extubation failure
Fraction of inspired oxygen shall be adjusted to maintain spo2 more than 92% Vital signs and arterial gas analysis will be measured at 1hr 24hr and 48hr |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
critically ill patients who are at high risk of extubation failure |
|
| ExclusionCriteria |
| Details |
Patient who dont give consent for part of study ,
Do not resuscitate orders,
Tracheostomised patients,
Age less than 18years,
Accidental or self extubation ,
Do not reintubate orders
Contraindication for NIV therapy |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reintubation within 48 hours of extubation |
48hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Postextubation respiratory failure within 7 days of extubation
Respiratory infection(ventilator associated pneumonia )
Sepsis or multiple organ failure,
ICU length of stay
Hospital length of stay
ICU mortality and
Hospital mortality |
7days |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2024 |
| 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="0"
Months="0"
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 - NO
|
|
Brief Summary
|
Post-extubation failure is defined as the need for reintubation within 48hrs of planned extubation.
Post extubation respiratory failure occurs in 10% to 20% of patients with planned extubation and results in reintubation
Re-intubation due to post-extubation failure is associated with poor outcomes which includes, An increased incidence of ventilator-associated pneumonia Increased mortality rates longer intensive care unit (ICU) and hospital stays. NIV is recommended in patients whom clinicians would normally consider NIV is beneficial (i.e. hypercapnic and obese patients)
A high flow nasal canula (HFNC), a relatively recent oxygenation device, offers sufficient warm humidity in addition to a high flow of oxygenation and PEEP.
Due to the high gas flow rate, HFNC can create a persistently positive airway pressure effect in the airway, which may have a beneficial physiologic effect. It is not clear which subgroups of patients could benefit with HFNC or NIV
A recent study shows NIV with active humidification was superior to HFNC for preventing re-intubation in patients with high-risk of extubation failure.
No study has been made to see the effects of post extubation NIV with passive humidification in comparison with HFNC in patients with post extubation failure.
Hence this study has been designed to compare NIV with passive humidification to HFNC in patients with postextubation failure.
|