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Non-invasive ventilation in childhood acute asthma

A prospective open randomized clinical trial of non-invasive ventilation versus standard therapy for children hospitalized with an acute exacerbation of asthma.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/11/010485
Enrollment
90
Registered
2017-11-14
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Acute asthma

Interventions

Intervention1: Non-invasive ventilation (CPAP): NIV (CPAP) group: CPAP device with face mask will be fitted to the childâ??s face, with settings: Starting pressure 8 cm H2O, increased to 10 cm H2O if

Sponsors

PGIMER Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children >24 months old, presenting to the Pediatric Emergency with acute asthma. Acute asthma will be diagnosed on the basis of (i) respiratory rate greater than WHOâ??s age-dependent WHO criteria; (ii) history of similar previous episodes or physician diagnosed asthma; and (iii) wheezing heard on auscultation.

Exclusion criteria

Exclusion criteria: 1. Clinical suspicion of bacterial pneumonia on the basis of: focal crackles or bronchial breathing, and/or chest x-ray findings suggesting pneumonia (consolidation, major infiltrates, pleural effusion). 2. Impending respiratory failure at presentation requiring direct PICU admission 3. Any contraindication to BiPAP use including altered mental status, recent bowel surgery, intractable vomiting, inability to protect airway 4. Current tracheostomy, home ventilation (IPPV or NIPPV) or home oxygen requirement 5. Prior receipt of oral steroid at the time of presentation 6. History of congenital heart disease or chronic respiratory disease (including bronchopulmonary dysplasia, cystic fibrosis, pulmonary hypertension) 7. Craniofacial abnormality 8. Pneumothorax.

Design outcomes

Primary

MeasureTime frame
Length of time to reach a PRAM score of less than or equal to 3Timepoint: Length of time after admission

Secondary

MeasureTime frame
1. Length of time to achieve hospital discharge criteria. 2. Length of time for omission of oxygen 3. Requirement of supplemental bronchodilator (median number of intravenous infusion hours, total salbutamol doses per patient per admission, median doses of salbutamol per day) 4. Requirement of intubation and invasive ventilation 5. Treatment-related adverse events 6. Readmission within 48 hours of discharge 7. In children who perform PFT, time to reach FEV1 80% predicted Timepoint: As defined in each item above.

Countries

India

Contacts

Public ContactJoseph L Mathew

PGIMER Chandigarh

DR.JOSEPH.L.MATHEW@GMAIL.COM911722755357

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026