| CTRI Number |
CTRI/2021/03/032024 [Registered on: 16/03/2021] Trial Registered Prospectively |
| Last Modified On: |
27/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between two oxygenation devices that is Venturi Mask and High Flow Nasal Cannula in patients after they are weaned off from Mechanical Ventilator |
|
Scientific Title of Study
|
Effect of High flow nasal cannula versus conventional Venturi mask oxygenation after planned extubation in intensive care unit patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohan Raj P |
| Designation |
Post graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of anaesthesia , Maulana Azad medical college ,Bahadur Shah ,Zafar marg , New Delhi
Central
DELHI
110002
India |
| Phone |
9943333636 |
| Fax |
|
| Email |
mohanpmailbox@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Poonam Bhadoria |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad medical college |
| Address |
BL Taneja block , Department of Anaesthesia , Maulana Azad medical college , Bahadur shah , Zafar marg , New Delhi
Central
DELHI
110002
India |
| Phone |
9968604213 |
| Fax |
|
| Email |
bhadoriap@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Mohan Raj P |
| Designation |
Post graduate Resident |
| Affiliation |
Maulana Azad medical college |
| Address |
Department of Anaesthesia , Maulana Azad medical college , Bahadur shah , Zafar marg , New Delhi
Central
DELHI
110002
India |
| Phone |
9943333636 |
| Fax |
|
| Email |
mohanpmailbox@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad medical college , Bahadur Shah , Zafar marg , New Delhi - 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad medical college |
| Address |
Bahadur Shah , Zafar marg , New Delhi |
| Type of Sponsor |
Government 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 |
| Mohan Raj P |
Lok Nayak hospital- Maulana Azad Medical College |
Department of anaesthesia, third floor BL Taneja. Block,Maulana Azad medical college , Bahadur Shah, Zafar Marg, New Delhi
Central
DELHI |
9943333636
mohanpmailbox@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Application of oxygenation device to the patient |
After the patient gets extubated , Either Venturi mask or High Flow Nasal Cannula will be used for oxygenation of the patient |
| Comparator Agent |
Venturi mask and High Flow Nasal cannula |
Venturi mask is an oxygenation device which can deliver oxygen at maximum of 15 L/min and 60%FiO2.
High Flow Nasal cannula (HFNC) is an oxygenation device which can deliver oxygen at maximum 70-80L/min and 100%. FiO2 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.BMI < 30
2.≤1 co morbidities
3.Minimum 12 hours and maximum of 7 days of intubaton period |
|
| ExclusionCriteria |
| Details |
1.Patients with congestive heart disease
2.Patients with moderate to severe COPD
3.Pregnant Patients
4.Patients who are planned for non invasive ventilation after intubation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The number of patients requiring non invasive ventilation or reintubation after planned extubation |
From the time of extubation till 24 hours after extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Time to non invasive ventilation/reintubation
2.Pao2/FiO2 ratio and PaCO2
3.Respiratory parameters-Respiratory rate and SpO2
4-Hemodynamic parameters- Heart rate and mean arterial pressure
5.Duration of Intensive Care Unit stay
6.Patient discomfort score |
PaO2/FiO2 ratio , PaCO2 , Respiratory rate , SpO2, Heart rate , Mean arterial pressure are recorded at 1,3,6,9,12,18,24 hours post extubation. |
|
|
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)
|
25/03/2021 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Majority of ICU patients often require endotracheal intubation and mechanical ventilation .As a standard protocol, intubated ICU patients after the resolution of underlying disease are gradually weaned from mechanical ventilation and there after extubated. Oxygenation and ventilation impairment may be seen in some patients after extubation. Post extubation respiratory management by supplemental oxygen therapy aims at decreasing early post extubation respiratory failure. Several devices are available for delivering oxygen to the ICU patients, which can be either a high flow system or low flow system . Venturi mask being routinely used since years for oxygen supplementation after extubation. It is a high flow oxygen delivery device which has the advantage of delivering precise Fio2 upto a maximum of 0.60.Inspite of being a high flow device it has disadvantage of air entrainement when the respiratory demand of patient increases leading to dilution of oxygen and also delivers non humidified oxygen which leads to airway mucosa dryness. Recently a new high flow device (AIRVO2) is being increasingly used. In this high flow device patients inhale a higher percentage of oxygen which saturates the nasopharynx with oxygen and increases the oxygen reserve in lungs. It can deliver oxygen upto 70L/min and FiO2 reaching upto 0.99-1.00.Gaseous exchange is facilitated by flow dependant dead space flushing . We hypothesize that High Flow Nasal Cannula (AIRVO2) may provide better oxygenation and comfort to the patient with better recruitement of alveoli after planned extubation than conventional oxygen therapy. |