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A randomised controlled trial evaluating the effectiveness of heliox in post-extubation stridor

A randomised controlled trial evaluating the effectiveness of heliox in post-extubation stridor

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN70123622
Enrollment
10
Registered
2003-09-12
Start date
2003-03-27
Completion date
Unknown
Last updated
2016-10-17

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

Conditions

Intubation Surgery

Interventions

Patients will be extubated initially into 30% FiO2, and their SpO2 recorded when stable for scoring purposes. Higher or lower FiO2 can then be given if needed. Patients will be entered into the study
2. At the moment that stridor is first recognised
3. One minute after randomisation
4. Every thirty minutes after randomisation, until the trial ends
and 5. At the end of any dose of nebulised adrenaline Any patient with a modified Syracuse score of 3 or more at points 3, 4 or 5 will receive nebulised adrenaline 1:1000 0.5ml/kg (maximum single d
if not, no further dose will be given until the next score (30 minutes after the last, pre-nebuliser score). A modified Syracuse score of 3 or more persisting after three continuous adrenaline nebulis

Sponsors

Department of Health (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All children intubated are eligible for the trial. Parents will be approached and consented at the appropriate time (prior to planned extubation).

Exclusion criteria

Exclusion criteria: Patients with undrained pneumothoraces or intracranial air will be excluded.

Design outcomes

Primary

MeasureTime frame
1. Stridor scores analysed by Student's t-test 2. Adrenaline use (directly linked to stridor scores) analysed by Student's t-test 3. Re-intubation rates analysed by Chi-squared test

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

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