A randomised controlled trial evaluating the effectiveness of heliox in post-extubation stridor
| ISRCTN | ISRCTN70123622 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70123622 |
| Secondary identifying numbers | N0241121241 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 16/03/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr James Austin
Scientific
Scientific
PICU
St Mary's Hospital
Praed Street
London
W2 1NY
United Kingdom
| Phone | +44 (0)20 7886 6666 |
|---|---|
| drjamesaustin@hotmail.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A randomised controlled trial evaluating the effectiveness of heliox in post-extubation stridor |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 27/03/2003 |
| Completion date | 31/08/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 10 (minimum) |
| Key inclusion criteria | All children intubated are eligible for the trial. Parents will be approached and consented at the appropriate time (prior to planned extubation). |
| Key exclusion criteria | Patients with undrained pneumothoraces or intracranial air will be excluded. |
| Date of first enrolment | 27/03/2003 |
| Date of final enrolment | 31/08/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
PICU
London
W2 1NY
United Kingdom
W2 1NY
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Hospital/treatment centre
St Mary's NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
16/03/2016: No publications found, verifying study status with principal investigator.
