Contact information
Type
Scientific
Primary contact
Dr James Austin
ORCID ID
Contact details
PICU
St Mary's Hospital
Praed Street
London
W2 1NY
United Kingdom
+44 (0)20 7886 6666
drjamesaustin@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0241121241
Study information
Scientific title
A randomised controlled trial evaluating the effectiveness of heliox in post-extubation stridor
Acronym
Study hypothesis
Does heliox have a role to play in the immediate management of post-extubation stridor, in reducing adrenaline requirement and need for re-intubation?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Intubation
Intervention
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 if they have any stridor at all (ie modified Syracuse score 1 or more) between 5 min and 24 h post extubation. This will be assessed by a doctor who is prepared to immediately randomise, and to start heliox if indicated. If stridor develops earlier than 5 min it should be observed if still present at 5 min then proceed with randomisation. As soon as a patient becomes eligible, he/she will be randomised by coin toss: HEads for HEliox , tails to simply continue on required FiO2. Patients randomised to heliox will commence this immediately.
The modified Syracuse score (DEVELOPED FOR THIS STUDY BUT BASED ON A VALIDATED SCORE - see below for details) will be scored:
1. At 5 minutes post-extubation;
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 dose 5ml). If the score remains 3 or more at the completion of a nebuliser, the dose will be immediately repeated; 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 nebulisers will be an indication for re-intubation.
Once started, heliox may be stopped if the modified Syracuse score is 0 on three successive occasions (i.e. for one hour). A further two scores should be obtained thereafter: if stridor returns within one hour off heliox, it may be recommenced.
A patient's involvement in the trial will be ended on any of the following:
1. the parent demands withdrawal from the study
2. the clinician feels that the study is compromising patient care
3. the patient is re-intubated
4. the patient is free of stridor for one hour, not being on heliox.
If a patient exits the trial and subsequently develops stridor again (within 24 hours of extubation), he/she may be re-entered and re-randomised. Thus one patient may enter the trial more than once, potentially in different treatment arms, if he/she has more than one episode of stridor separated by at least one hour.
Pre-extubation dexamethasone is neither encouraged nor discouraged by this trial, but should be recorded in either event. The avoidance of steroids would probably increase the numbers of patients eligible for the study; however, it would not be ethical to deny the patient this treatment if the clinician felt it was clinically indicated.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measure
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 outcome measures
Not provided at time of registration
Overall trial start date
27/03/2003
Overall trial end date
31/08/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All children intubated are eligible for the trial. Parents will be approached and consented at the appropriate time (prior to planned extubation).
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
10 (minimum)
Participant exclusion criteria
Patients with undrained pneumothoraces or intracranial air will be excluded.
Recruitment start date
27/03/2003
Recruitment end date
31/08/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
PICU
London
W2 1NY
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
St Mary's NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list