Condition category
Respiratory
Date applied
27/07/2006
Date assigned
22/09/2006
Last edited
24/05/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Vilas Navapurkar

ORCID ID

Contact details

John Farman Intensive Care Unit
Box 17
Addenbrookes Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 217433
vilas@vilas.orangehome.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 3.0 23/07/08; 05/Q0108/337

Study information

Scientific title

Acronym

HOPE-DTSM

Study hypothesis

Do helium-oxygen gas mixtures reduce re-ventilation rate in adult Intensive Treatment Unit (ITU) patients at risk of extubation failure?

As of 24/03/2009 this record has been updated; all changes can be found in the relevant fields under the above update date. Please also note that the anticipated start and end date have also been updated; the initial information at the time of registration were:
Initial anticipated start date: 24/07/2006
Initial anticipated end date: 28/07/2008

Ethics approval

Reviewed by Cambridge Research Ethics Committee and given favourable opinion on January 18th 2006 (reference number: 05/Q0108/337)

Study design

Prospective, single centre, randomised controlled phase IV study employing a sequential statistical method.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Post extubation respiratory failure or distress

Intervention

24/05/2013: Please note that this trial was stopped on 01/08/2009

Subjects are randomised to either helium-oxygen or air-oxygen.

Intervention type

Drug

Phase

Phase IV

Drug names

Helium-oxygen gas mixture

Primary outcome measures

Re-ventilation rate at 24 hours.

Secondary outcome measures

Partial pressure of oxygen in arterial blood (PaO2)/fraction of inspired oxygen (FiO2) ratios and partial pressure of carbon dioxide in arterial blood (PaCO2) at four hourly intervals post-extubation.

Overall trial start date

23/03/2009

Overall trial end date

23/03/2011

Reason abandoned

Lack of staff/facilities/resources

Eligibility

Participant inclusion criteria

Amended as of 24/03/2009:
1. Cuff leak less than 140 ml after 48 hours mechanical ventilation
2. Suction more often than 2-hourly in the 4 - 6 hours prior to extubation
3. Failure of earlier spontaneous breathing trial
4. Intubated for airway obstruction
5. Hypercapnia greater than 6 kPa (45 mmHg) on last gas prior to extubation
6. Glasgow Coma Score less than 8 (Verbal Score is 1)
7. Cough peak flow less than 70 l/min
8. Mechanical ventilation greater than 48 hours and Rapid Shallow Breathing Index greater than 57 and a positive fluid balance over the previous 24 hours
9. Mechanical ventilation greater than 48 hours and a positive fluid balance of greater than 1 litre over previous 24 hours

Initial information at time of registration:
1. Intubated for airway obstruction
2. Glasgow Coma Score of less than eight at extubation
3. Failing a rapid wean protocol
4. Significant bronchorrhoea
5. Cuff Leak of less than 140 ml
6. Cough peak flow less than 60 ml/min

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Over 100

Participant exclusion criteria

Amended as of 24/03/2009:
1. Recent or current diagnosis of pneumothorax, surgical emphysema, or fractured ribs
2. Patients in whom there is no intention to re-ventilate upon tracheal extubation i.e. terminal extubation
3. Patients who are extubated accidentally
4. Patients with a tracheostomy
5. Patients who have been admitted to intensive care electively following surgery
6. Patients who use non-invasive ventilation (NIV) at home
7. Patients in whom there is clinical doubt from the research team concerning the clinical decision to extubate the patient, where recourse to the critical care consultant on duty is not available
8. Next of kin refuse assent
9. Informed consent is refused by the patient or their legally appointed representative at any stage during or after data collection

Initial information at time of registration:
1. Recent or current diagnosis of pneumothorax, surgical emphysema, or fractured ribs
2. Patients in whom there is no intention to re-ventilate upon tracheal extubation i.e. terminal extubation
3. Patients who are extubated accidentally
4. Patients with a tracheostomy
5. Patients who have been admitted to Intensive Care following elective surgery
6. Next of kin refuse assent
7. Informed consent is refused by the patient or their legally appointed representative
at any stage during or after data collection

Recruitment start date

23/03/2009

Recruitment end date

23/03/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

John Farman Intensive Care Unit
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

Box 277
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.cuh.org.uk/addenbrookes/addenbrookes_index.html

Funders

Funder type

Industry

Funder name

BOC Medical (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Cambridge University Hospitals NHS Foundation Trust (UK) - Division of Anaesthesia, Addenbrookes Hospital

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