| CTRI Number |
CTRI/2020/10/028551 [Registered on: 22/10/2020] Trial Registered Prospectively |
| Last Modified On: |
05/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of two different methods for providing oxygen in patients |
|
Scientific Title of Study
|
Comparitive Study of Non Invasive Ventilation Delivered by Helmet mask vs Face Mask in Post Extubated ICU Patients:A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SUBHASREE N |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Science,BHU |
| Address |
Department of Anesthesiology, Institute of Medical Sciences,BHU
UTTAR PRADESH
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9965953891 |
| Fax |
|
| Email |
arunasree3093@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr RAJESH KUMAR MEENA |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences,BHU, Varanasi |
| Address |
Department of Anesthesiology, Institute of Medical Sciences,BHU
Varanasi
UTTAR PRADESH
221005
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9643975465 |
| Fax |
|
| Email |
drrajaiims86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr RAJESH KUMAR MEENA |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences,BHU, Varanasi |
| Address |
Department of Anesthesiology, Institute of Medical Sciences,BHU
Varanasi
UTTAR PRADESH
221005
India
Sonbhadra
UTTAR PRADESH
221005
India |
| Phone |
9643975465 |
| Fax |
|
| Email |
drrajaiims86@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences,BHU,Varanasi-221005 |
|
|
Primary Sponsor
|
| Name |
Institute of Medical SciencesBHU Varanasi |
| Address |
Department of Anesthesiology, Institute of Medical Sciences,BHU,
Varanasi, |
| 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 |
| Dr SUBHASREE N |
Sir Sundarlal Hospital |
Intensive Care Unit,Intensive Care Division,Department of
Anesthesiology,
Institute of Medical
Sciences,BHU
Varanasi
UTTAR PRADESH
Varanasi
UTTAR PRADESH |
9965953891
arunasree3093@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Faculty of Medicine, Institute of Medical Sciences,BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J958||Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Face Mask |
effect of non invasive ventilation delivered by face mask in preventing reintubation in postextubated patients. It may be from 1 hour to 2 days |
| Comparator Agent |
Helmet mask |
Non invasive ventilation by helmet mask in preventing reintubation in postextubated patients. It may be from 1 hour to 2 days |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients in mechanical ventilation for 3 days |
|
| ExclusionCriteria |
| Details |
Patient refusal
Patients not in mechanical ventilation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| proportion of patients who required endotracheal reintubation |
3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 28-day invasive ventilator– free days, patient compliance, duration of ICU and hospital length of stay, and hospital and 90-day mortality. |
3,28,90 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "61"
Final Enrollment numbers achieved (India)="61" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/10/2020 |
| Date of Study Completion (India) |
06/05/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Noninvasive ventilation (NIV) as a weaning-facilitating strategy in mechanically ventilated patients predominantly in chronic obstructive pulmonary disease (COPD) patients. In this study we are going to compare the effect of non invasive ventilation delivered by face mask vs Helmet mask in preventing Reintubation , respiratory failure and patient comfort. This randomized prospective study will be carried 120 adult patients of age group of 15-70 years of either sex who is on mechanical ventilation for 5 days with 60 patients in each group who will be randomly allocated by sealed envelope method. After the approval by the Institutional Ethical Committee, written informed consent will be obtained from all the patient before being included in the study. They will be allocated to following 2 groups randomly with 60 patients in each group.
Group H- Patients will be on Helmet mask Group F- Patients will be on Face mask Vital signs and arterial blood gas parameters and patient comforthas beed noted in both groups. |