Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
16/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

16/03/2016: No publications found, verifying study status with principal investigator.