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Clinical Trials/CTRI/2024/07/069786
CTRI/2024/07/069786
Not yet recruiting
Not Applicable

Efficacy of high flow nasal cannula versus indigenous bubble continuous positive airway pressure & conventional oxygen through nasal cannula in moderate bronchiolitis A Randomized controlled trial

Pradeep Reddy V1 site in 1 country129 target enrollmentStarted: July 15, 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Pradeep Reddy V
Enrollment
129
Locations
1
Primary Endpoint
Time to wean off oxygen (hrs)

Overview

Brief Summary

This randomized controlled open lable study will be conducted in the Department of Paediatrics, Sri Manakula Vinayagar Medical College And Hospital(SMVMCH) a tertiary care hospital in Puducherry after the approval of Research Committee and Institutional Ethics Committee .Any infant  from 1month to 24 months age, who fulfill the inclusion and exclusion criteria will be included in the study after the informed and written consent is being obtained from parents.

 Sequential number, sealed opaque envelope will be opened by the post graduate , the child will be allotted to respective intervention group as per the block randomized list. Based on socio demographic details, anthropometry, heart rate, respiratory rate, SPO2, CSS score will be recorded in the proforma at 0 min,1hr,3hr,6hr,12hr,24hr,48hr,72hr and greater than 72hr.

 The participants clinical condition and intervention will be explained to the parents and mode of oxygen delivery will be assigned for (Group A - HFNC)  (Group B – Indigenous bubble CPAP) and  (Group C – Nasal prongs). They are assessed at 0 min,1hr,3hr,6hr,12hr,24hr,48hr,72hr and greater than 72hr.

Infants with HFNC group will be delivered Humidified Oxygen  using Fisher and Paykal HFNC machine. Children allotted into indigenous bubble CPAP group will be delivered oxygen  using Chest drainage bottle 500ml with Nasal prongs, Children allotted into prongs group will be delivered oxygen using appropriate size Nasal prong cannula system connected directly.

 Time for resolution of underlying condition will be sequentially monitored in HFNC, indigenous bubble CPAP and prongs group and will be entered.

 Children labeled to have treatment failure if they have :

•         Hypoxia

•         Fio2> 60%

•         Retractions persists

•         Developing shock requiring inotrope support

Cross over is possible from Group A to Group C if response is  adequate. At serial reassessment if response is not adequate in group B or C, cross over will be done to group A. In worsening of symptoms and non-responders, Escalation of treatment will be proceeded to  Invasive ventilation or mechanical ventilation.

Nasal trauma will be classified at the point of  removal .

Compliance of nasal prongs, indigenous bubble CPAP and HFNC is being measured by using number of instances readjustment needed by every 2nd hourly monitoring the position of HFNC and prongs for respective group of patients.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
1.00 Month(s) to 24.00 Month(s) (—)
Sex
All

Inclusion Criteria

  • One month to 24 month old child Moderate bronchiolitis.

Exclusion Criteria

  • Parents of children who refused to give consent.
  • Referred patients who already received HFNC outside in other hospitals and referred with complications of it.
  • Those with added cardiac illness Anatomical abnormalities of respiratory tract Moderate bronchiolitis Other respiratory illnesses like pneumonia, pleural effusion, pyothorax.

Outcomes

Primary Outcomes

Time to wean off oxygen (hrs)

Time Frame: Based on socio demographic details, anthropometry, heart rate, respiratory rate, SPO2, CSS score will be recorded in the proforma at 0 min,1hr,3hr,6hr,12hr,24hr,48hr,72hr and greater than 72hr.

Primary treatment duration (hrs)

Time Frame: Based on socio demographic details, anthropometry, heart rate, respiratory rate, SPO2, CSS score will be recorded in the proforma at 0 min,1hr,3hr,6hr,12hr,24hr,48hr,72hr and greater than 72hr.

Instances of requirement of readjustments

Time Frame: Based on socio demographic details, anthropometry, heart rate, respiratory rate, SPO2, CSS score will be recorded in the proforma at 0 min,1hr,3hr,6hr,12hr,24hr,48hr,72hr and greater than 72hr.

Grade of nasal soft tissue injury

Time Frame: Based on socio demographic details, anthropometry, heart rate, respiratory rate, SPO2, CSS score will be recorded in the proforma at 0 min,1hr,3hr,6hr,12hr,24hr,48hr,72hr and greater than 72hr.

Primary treatment failure

Time Frame: Based on socio demographic details, anthropometry, heart rate, respiratory rate, SPO2, CSS score will be recorded in the proforma at 0 min,1hr,3hr,6hr,12hr,24hr,48hr,72hr and greater than 72hr.

Secondary Outcomes

  • Picu length of stay (days)(Hospital length of stay (days))

Investigators

Sponsor
Pradeep Reddy V
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Pradeep Reddy V

sri manakula vinayagar medical collage and hospital

Study Sites (1)

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