| CTRI Number |
CTRI/2021/04/032501 [Registered on: 01/04/2021] Trial Registered Prospectively |
| Last Modified On: |
18/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effect of High Flow Nasal Cannula with Continuous Positive Airway Pressure in reducing incidence of invasive mechanical ventilation in severe COVID 19 patients. |
|
Scientific Title of Study
|
Comparison of efficacy of HighFlow Nasal Cannula with Continuous Positive Airway Pressure in prevention of Invasive mechanical ventilation in COVID 19 patients with Acute Respiratory Distress Syndrome in Critical Care Unit- A Randomized Control Study |
| Trial Acronym |
COVID HFNC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anand K |
| Designation |
Professor |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Room No 209,Second Floor,B Block, Department Of Anaesthesiology,SRM Nagar, Potheri, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9865282288 |
| Fax |
|
| Email |
dranand@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anand K |
| Designation |
Professor |
| Affiliation |
SRM Medical College |
| Address |
Room NO 209,Second Floor,B Block, Dept Of Anaesthesiology,SRM Nagar, Potheri, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9865282288 |
| Fax |
|
| Email |
dranand@outlook.com |
|
Details of Contact Person
Public Query
|
| Name |
Gunasri K |
| Designation |
Junior Resident |
| Affiliation |
SRM Medical College |
| Address |
Room No 209,Second Floor,B Block, Department Of Anaesthesiology,SRM Nagar, Potheri, Kattankulathur.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9865282288 |
| Fax |
|
| Email |
k.gunasri@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical College and Research Centre |
|
|
Primary Sponsor
|
| Name |
SRM Medical College and Research Centre |
| Address |
SRM Nagar, Potheri, Kattankulathur |
| 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 Anand K |
SRM Medical College and Research Centre |
Room no 209, Second floor, B Block, Department of Anaesthesiology, SRM Nagar, Potheri, Kattankulathur
Kancheepuram
TAMIL NADU |
9865282288
dranand@outlook.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, SRM Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J96||Respiratory failure, not elsewhereclassified, (2) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CPAP NIV - Continuous Positive Airway Pressure Non Invasive Ventilation |
CPAP NIV is a mode of ventilation used to treat mild to moderate ARDS |
| Intervention |
High flow nasal cannula HFNC |
High Flow Nasal Cannula (HFNC) therapy is an alternative method of oxygen supplementation in critical care unit with COVID 19 patients. HFNC has been recommended in management of COVID 19 patients with mild and moderate Adult Respiratory Distress Syndrome. It administers humidified oxygen with controlled fraction of inspired oxygen (FiO2 21-100%) at a maximal flow rate of 60L/min via nasal cannula. HFNC improves oxygenation by delivering increased fraction of inspired oxygen (FiO2), washing out and reducing dead space, generating PEEP and enabling patients to lie in awake prone position |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
All COVID -19 positive patients ( by RT-PCR) with paO2/Fio2 (P/F) – 150 to 250, with good sensorium, stable hemodynamics and pH > 7.2
Absence of nasal pathology
|
|
| ExclusionCriteria |
| Details |
Hemodynamically unstable patients
Patients in shock/ severe acidosis
Epistaxis, basal skull fracture
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of High Flow Nasal Cannula and Non Invasive Ventilation -Continuous Positive Airway Pressure in reducing need for invasive mechanical ventilation in patients with ARDS in COVID-19. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient’s compliance to therapy - comfort / noise level, ability to prone |
24 hours |
| Ability to alleviate dyspnoea as assessed by modified Borg scale |
24 hours |
| Ability of ROX index to identify COVID 19 patients on HFNC requiring invasive mechanical ventilation. |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/04/2021 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
All COVID-19 positive patients with ARDS who are admitted
to critical care unit at SRM Medical College and Hospital, Kattankulathur will
be enrolled in the study. Institutional ethical committee approval and informed
written consent from patients will be obtained. Patients who meet the
inclusion criteria will be allocated into 2 groups - Group H (HFNC), Group C
(CPAP), randomised by computer generated random numbers and concealed using
sealed envelope technique.
Sample Size Calculation
Sixty COVID-19
positive patients getting admitted into critical care unit and who fullfill
inclusion criteria will be taken up for the study. PROCEDURE:
After obtaining informed consent,,patients who meet
the inclusion criteria will be randomly allocated into 2 groups - Group H (HFNC), Group C (CPAP) , generated
by computer randomization and concealed using sealed envelope technique.
In GROUP –H -Arterial blood
gas analysis will be done for all patients who desaturate in room air
(spO2<94%) and require oxygen supplementation. Patients with P/F ratio of
150-250 who satisfy inclusion criteria will be administered HFNC with initial
settings of FiO2 40% with a flow rate of
40 l/min. Patients will be continuously monitored clinically by Respiratory
rate, increased work of breathing as assessed by overactive accessory
respiratory muscles and objectively by continuous pulse oximetry, arterial
blood gas analysis every 12th hourly. In event of deterioration of
respiratory parameters, FiO2 can be increased to 100% and flow rate can be
increased to 60 l/min. The ability of HFNC to reduce respiratory distress will
be assessed by modified Borg scale. Patients will be asked to assess ease of proning,
overall comfort level and noise in both groups. ROX index will be calculated
for all patients 12th hourly and documented. If patient’s sensorium
deteriorates or develops severe acidosis (pH<7.2) or P/F<150, tracheal
intubation and invasive mechanical ventilation will be initiated.
GROUP- C :Arterial blood gas analysis of
all patients who desaturate in room air (spO2<94%) and require oxygen
supplementation will be done. Patients with P/F ratio of 150-250 who satisfy
inclusion criteria will be administered CPAP with PS -10 cm of water and oxygen
flow will be titrated according to spo2.
Parameters
compared:
1. Respiratory rate
2. Work of breathing – by use of accessory muscle
3. SpO2
4. PCO2
5. P/F ratio
6. Modified Borg scale
7. HFNC settings -
flow & fio2
8. ROX Index
MODIFIED
BORG DYSNOEA SCALE
|
0
|
Nothing at all
|
|
0.5
|
Extremely slight/just noticeable
|
|
1
|
Very slight
|
|
2
|
slight
|
|
3
|
Moderate
|
|
4
|
Some what severe
|
|
5
|
severe
|
|
6
|
severe
|
|
7
|
Very severe
|
|
8
|
Very severe
|
|
9
|
Extremely severe
|
|
10
|
Maximal
|
ROX INDEX:(spo2/fio2)
/ respiratory rate
At end of
6hours, ROX > 4.88
: Doesn’t need intubation
ROX < 3.47 : requires intubation
STATISTICAL ANALYSIS:
Unpaired ‘t’ test and chisquare will be used for performing the analysis.
|