| CTRI Number |
CTRI/2023/05/052491 [Registered on: 11/05/2023] Trial Registered Prospectively |
| Last Modified On: |
10/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
PROVIDING OXYGEN BY NASAL PRONGS AT FLOW MORE THAN 2 LITRES PER MINUTE VERSUS PROVIDING OXYGEN WITH NASAL PRONGS USING CPAP DEVICE IN CHILDREN WITH DIFFICULTY IN BREATHING. |
|
Scientific Title of Study
|
TO COMPARE OUTCOMES OF HUMIDIFIED HIGH FLOW NASAL CANNULA VERSUS NASAL CONTINOUS POSITIVE AIRWAY PRESSURE IN CHILDREN WITH RESPIRATORY DISTRESS:A RANDOMISED CONTROLLED TRIAL. |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Motukuri Sesha Sarat Chandra |
| Designation |
Junior Resident |
| Affiliation |
MGM Medical College |
| Address |
Room no-360, Third floor, Department of Pediatrics,
N6 CIDCO, MGM Medical College.
Room no-360, Third floor, Department of Pediatrics,
N6 CIDCO, MGM Medical College.
Aurangabad
MAHARASHTRA
531002
India |
| Phone |
8096692642 |
| Fax |
|
| Email |
sc73010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjali Vasant Kale |
| Designation |
Professor |
| Affiliation |
MGM Medical College, Aurangabad |
| Address |
Room no-360, Third floor, Department of Pediatrics, MGM Medical College, N6 CIDCO, Aurangabad,
N6 CIDCO, MGM Medical College, Aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9325212376 |
| Fax |
|
| Email |
drkaleav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Motukuri Sesha Sarat Chandra |
| Designation |
Junior Resident |
| Affiliation |
MGM Medical College, Aurangabad |
| Address |
Room no-360, Department of Pediatrics, N6 Cidco, MGM Medical College, Aurangabad
Room no-360, Department of Pediatrics, N6 Cidco, MGM Medical College, Aurangabad
Aurangabad
MAHARASHTRA
531002
India |
| Phone |
8096692642 |
| Fax |
|
| Email |
sc73010@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM medical college ,Aurangabad |
|
|
Primary Sponsor
|
| Name |
Motukuri Sesha Sarat Chandra |
| Address |
Room no- 360, Third floor, Department of Pediatrics, N6, CIDCO, MGM Medical College Aurangabad.
|
| Type of Sponsor |
Other [Principal Investigator (self ) ] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Motukuri Sesha Sarat Chandra |
MGM Medical College |
room no-360, department of pediatrics, first floor, MGM Hospital, N-6 CIDCO, Aurangabad
Aurangabad
MAHARASHTRA |
8096692642
sc73010@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGMECRHS |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Continuous Positive Airway Pressure (CPAP). |
Fischer and Paykel Bubble CPAP Pressuried oxygen from central source will be delivered through a flow meter to the patient by a nasal prongs. The amount of CPAP to be delivered will be determined by adjusting the height of water column: 1cm equal to 1cm water pressure. With oxygen flow at 5 liters per minute to achieve saturation of more than 92 percent
frequency and duration of device will depend on the patient status that is breathlessness and will be removed if breathlessness decreases
|
| Intervention |
High Flow Nasal Cannula (HFNC) |
Eligible Patients Randomized to receive Intervention will be provided high flow oxygen Using MR850 Fischer and Paykel Health Care System. FIo2 from 0.21 to 1 will be adjusted to achieve at least 95 percent of oxygen saturation. flow rate will be started at 6 liters per minute and increased un till continuous airflow is heard at basal lungs bilaterally.
frequency and duration of device will depend on the patient status that is breathlessness and will be removed if breathlessness decreases
|
|
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Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
All children from 1 month to 18 years having Respiratory distress |
|
| ExclusionCriteria |
| Details |
Intubation on admission
Children with congenital heart diseases
Children with neurological diseases
Covid positive patients
Children with chest wall deformity
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
Success & failure rate of the intervention done. Success is defined as patient not requiring invasive ventilation after the intervention. Failure is defined as patient requiring invasive ventilation.
|
Assessed from time of admission till 72 hours of intervention |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Document complications like abdominal distension, feeding intolerance, nasal mucosal injury, prolonged ICU stay and discharge on oxygen supplementation |
After starting intervention till discharge or death |
|
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Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
15/05/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Yes |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
To compare out comes of humidified high flow nasal cannula versus continuous positive airway pressure in children of respiratory distress presenting to tertiary care hospital Aurangabad.Primary objective: To compare success rate/failure rate between HFNC & CPAP treatment group. (success is defined if patient is started on non-invasive ventilation and does not require invasive ventilation throughout the course, Failure is defined as if patient requiring invasive ventilation after non-invasive ventilation) Secondary objective: To study complications like abdominal distension, issue of feeding intolerance, nasal mucosal injury, discharge on oxygen supplementation & prolonged ICU stay.
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