| CTRI Number |
CTRI/2023/11/059792 [Registered on: 14/11/2023] Trial Registered Prospectively |
| Last Modified On: |
08/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
To assess which mask is comfortable for the patient |
|
Scientific Title of Study
|
Comparative analysis of comfort of Non-invasive ventilation (NIV) with conventional oronasal mask and bridge free oronasal mask A Randomised controlled trial |
| 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 MANOJ KAMAL |
| Designation |
PROFESSOR |
| Affiliation |
All India Institute of Medical Sciences Jodhpur |
| Address |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR Cardiothoracic and Vascular Surgery OT Sixth floor D & T Block,, 3rd floor aicu jodhpur RAJASTHAN 342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9414084584 |
| Fax |
|
| Email |
geethamanoj007@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MANOJ KAMAL |
| Designation |
PROFESSOR |
| Affiliation |
All India Institute of Medical Sciences Jodhpur |
| Address |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR Cardiothoracic and Vascular Surgery OT Sixth floor D & T Block,, 3rd floor aicu jodhpur RAJASTHAN 342005
RAJASTHAN
342005
India |
| Phone |
9414084584 |
| Fax |
|
| Email |
geethamanoj007@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR GURAVANA BHAVANI PRASAD |
| Designation |
Junior Resident |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR |
| Address |
AICU ,department of Anaesthesiology and Critical Care 3rd Floor D&T Block ,AIIMS Jodhpur RAJASTHAN 342005
Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8919345852 |
| Fax |
|
| Email |
bhavaniprasad878@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical sciences |
| Address |
All India Institute of Medical Sciences
basni industrial area phase 2
jodhpur - 342005 |
| 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 Manoj Kamal |
All India institute of Medical Sciences , Jodhpur |
601 Cardiothoracic and Vascular surgery OT, 6th floor D&T Block AIIMS Jodhpur Rajasthan
Jodhpur
RAJASTHAN
Jodhpur
RAJASTHAN |
9414084584
geetamanoj007@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee , AIIMS , Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J962||Acute and chronic respiratory failure, (2) ICD-10 Condition: J810||Acute pulmonary edema, (3) ICD-10 Condition: J958||Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIV WITH BRIDGE FREE ORONASAL MASK |
This is a cross-over study so patients will be assessed regarding comfort using a questionnaire after using the bridge-free oronasal mask for 2 hours and a conventional oronasal mask for the next 2 hours. In the AB sequence, 2 hours NIV trial with bridge free oronasal mask, followed by 2 hour NIV trial with a conventional oronasal mask, while in the BA sequence, 2 hour NIV trial with a conventional oronasal mask, followed by NIV with bridge free oronasal mask |
| Comparator Agent |
NIV WITH CONVENTIONAL ORONASAL MASK |
This is a cross-over study so patients will be assessed regarding comfort using a questionnaire after using the bridge-free oronasal mask for 2 hours and a conventional oronasal mask for the next 2 hours. In the AB sequence, 2 hours NIV trial with bridge free oronasal mask, followed by 2 hour NIV trial with a conventional oronasal mask, while in the BA sequence, 2 hour NIV trial with a conventional oronasal mask, followed by NIV with bridge free oronasal mask |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
All patients of either sexes, aged >18 years whether medical or post-surgical who will be fulfilling the criteria of NIV support which include
1. Acute respiratory failure type2
2. Pulmonary edema
3. Weaning in high-risk surgeries
4. Weaning after using mechanical ventilator >7 days
5. Weaning after continuous sedation >72 hrs
6. APACHE II >17.5 |
|
| ExclusionCriteria |
| Details |
Patients who refused to give consent , hemodynamically unstable, morbidly obese, depressed consciousness, and have improper NIV mask fitting will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine Comfort of patient assessed by using LIKERTS scale |
To determine Comfort of patient assessed by using LIKERTS scale after 4 hours i.e after using both masks for 2 hours each |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1, Assessing Blood gas Parameters like PH, PCO2. PO2, HCO3, Na/K
2, Assesing Physiological parameters Like respiratory rate, Blood pressure, SPO2, Pulse rate
3, Assesing Ventilator parameters like leakage, fio2
4, Complications of NIV mask like facial skin erythema, nasal congestion, nasal or oral dryness, nose/sinus/ear pain, airways dryness
|
The hemodynamic parameters such as RR, HR, NIBP/ABP, and SpO2 will be recorded every 30 minutes.
Ventilatory parameters like fio2 and leakage hrly The ABG sample will be taken at baseline and every 2 hours during the intervention. Complications of NIV mask-like facial skin erythema, nasal congestion, nasal or oral dryness, nose/sinus/ear pain, and airway dryness will be assessed after the intervention.
|
|
|
Target Sample Size
|
Total Sample Size="83"
Sample Size from India="83"
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 4 |
|
Date of First Enrollment (India)
|
25/11/2023 |
| 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 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
|
| The enrolled patients will be randomized in AB or BA sequence. In the AB sequence, 2 hours NIV trial with Bridge free oronasal mask, followed by 2 hour NIV trial with a conventional oronasal mask, while in the BA sequence, 2 hour NIV trial with a conventional oronasal mask, followed by NIV with Bridge free oronasal mask. The sequence allocated will be concealed in sealed opaque envelopes. The NIV will be applied with an appropriate size conventional or bridge-free oronasal mask. The comfort of the NIV mask will be assessed by LIKERTS SCALE using S3NIV [11] standardized questionnaire and each question has a score of a minimum of 0 to a maximum of 4 And questionnaire includes 5 questions 1. My mask is comfortable 2. I don’t have any difficulty speaking 3. My mask is lightweight 4. I am not having claustrophobia 5. I am not suffering from nasal or oral dryness And scoring will be assessed for each question based on the response of the patient as follow 0- Completely untrue 1- Mostly untrue 2- Sometimes true 3- Mostly true 4- Always true With 0 as minimum satisfaction and 4 as maximum satisfaction And for total maximum allowable score is 20 and the minimum is 0. The questionnaire will be asked at the end after the trial with both the brige free and conventional niv mask. The hemodynamic parameters such as RR, HR, NIBP/ABP, and SpO2 will be recorded every 30 minutes. Ventilatory parameters like fio2 and leakage The ABG sample will be taken at baseline and every 2 hours during the intervention. Complications of NIV mask-like facial skin erythema, nasal congestion, nasal or oral dryness, nose/sinus/ear pain, and airway dryness will be assessed after the intervention. NIV failure: If patients will not improve with the first treatment of both arms (RR >35 bpm or spo2 <92% or increased work of breathing) then patients will not be exposed to the second treatment and labeled as NIV failure. These patients will be not included in the analysis. Device or mask failure: If patients respond to the first treatment but do not respond to the second treatment then further treatment will be based on the decision of the treating consultant, whether go for the first treatment or take the decision of invasive ventilation. | |