| CTRI Number |
CTRI/2024/05/067659 [Registered on: 20/05/2024] Trial Registered Prospectively |
| Last Modified On: |
12/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Mode of oxygenation] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of High flow nasal cannula and Non invasive ventilation in type 1 respiratory failure |
|
Scientific Title of Study
|
Highflow nasal cannula versus noninvasive ventilation in the prevention of escalation to invasive mechanical ventilation in patients with acute hypoxemic respiratory failure. A Randomised Comparative Interventional Study at SMS Medical College |
| 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 Nihar Sharma |
| Designation |
Associate Professor |
| Affiliation |
Sms medical college |
| Address |
Department of Anaesthesiology, S.M.S Medical College,Jaipur,
Rajasthan
Jaipur
RAJASTHAN
302016
India
Jaipur
RAJASTHAN
302001
India |
| Phone |
9314044376 |
| Fax |
|
| Email |
drniharsharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nihar Sharma |
| Designation |
Associate Professor |
| Affiliation |
Sms medical college |
| Address |
Department of Anaesthesiology, S.M.S Medical College,Jaipur,
Rajasthan
Jaipur
RAJASTHAN
302016
India
Jaipur
RAJASTHAN
302001
India |
| Phone |
9314044376 |
| Fax |
|
| Email |
drniharsharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavita M |
| Designation |
Resident Doctor |
| Affiliation |
Sms medical college |
| Address |
Department of Anaesthesiology, S.M.S Medical College, Jaipur,
Rajasthan
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN
302001
India |
| Phone |
8147475844 |
| Fax |
|
| Email |
kavitam1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, S.M.S Medical College |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology SMS Medical College |
| Address |
Department of Anaesthesiology, S.M.S Medical College,Jaipur |
| 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 Kavita M |
sms medical college |
1st floor medical icu dhanwantri
Jaipur
RAJASTHAN |
8147475844
kavitam1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the ethics comittee sms medical college and attatched hospitals jaipur |
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 |
| Comparator Agent |
HFNC |
Using High-flow nasal cannula in the prevention of escalation to invasive mechanical ventilation in patients with acute hypoxemic respiratory failure.
|
| Comparator Agent |
Noninvasive ventilation |
Using noninvasive ventilation in the prevention of escalation to invasive mechanical ventilation in patients with acute hypoxemic respiratory failure |
| Intervention |
prevention of escalation to invasive mechanical ventilation in patients with acute hypoxemic respiratory failure |
prevention of escalation to invasive mechanical ventilation in patients with acute hypoxemic respiratory failure using High-flow nasal cannula or noninvasive ventilation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing to give consent
Patients having AHRF defined by PaO2/FiO2 less than or equal to 300mmhg
Patient not responding to conventional oxygen therapy
Patient requiring ventilator support due to increased respiratory rate |
|
| ExclusionCriteria |
| Details |
Absolute indication for intubation
Contraindication to NIV
PaCO2 more than 45mmhg
Chronic respiratory failure
|
|
|
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 |
| To Assess Need for Invasive Mechanical Ventilation In Patients of Acute Hypoxemic Respiratory Failure. |
until Invasive Mechanical Ventilation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To measure vital parameters (SBP, DBP, MAP, HR, RR, SPO2)
2.To assess respiratory acidosis by recording ABG.
3.To assess duration of lCU stay.
4.To measure hospital mortality.
|
1.At admission, 12hours, 24hours,36hours, 72hours
2.AT 1hour ,6hours ,24hours ,48hours.
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
23/06/2024 |
| 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="3"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - data will be stored with principal and controller
- For how long will this data be available start date provided 20-01-2024 and end date provided 02-01-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Patients with AHRF will be admitted to ICU.
Sample of patients satisfying the inclusion criteria will be selected for study and patients will be randomized into two groups by computer random number table method.
Patients will be assigned to NIV or HFNC.
Patient assigned NIV will be connected to ventilator for conventional NIV with full mask with following ventilator settings with PEEP 2 to 10 cm of water initially later PEEP or FiO2 or both will be set to keep SaO2≥92%. Ps level will be set to achieve expiratory tidal volume of 7 to 10 ml/kg.
Patient of other group will be connected to HFNC and heated humidified oxygen 31-37 C will be continuously supplied through binasal large bore prongs. Initial setting of oxygen flow rate will be 50L/min and FiO21.0, later setting of Fio2will be adjusted to attain SaO2≥92%
Following parameter will be recorded in both groups
1. Total number of patients in percentage will be required need of intubation due to following reasons pH < 7.20
paO2 <45mmHg
paCO2 >60mmHg
Cardiopulmonary arrest
2. To Measure Vital parameters (SBP, DBP, MAP, HR, RR, SPO2) at inclusion and at 12, 24, 36, 48, 60, 72 hours. 3. To Assess Respiratory Acidosis by recording ABG at 1, 6, 24, 48 hours of study treatment. 4. To Assess no. of days on HFNC/NIV before escalation to intubation. 5. To Assess no. of duration of ICU stay. 6. To Measure Hospital Mortality. |