A trial of Helium-Oxygen mixtures in the immediate Post Extubation period in adult intensive care, using novel Decision-Theoretic Statistical Methodology

ISRCTN ISRCTN99817649
DOI https://doi.org/10.1186/ISRCTN99817649
Secondary identifying numbers Version 3.0 23/07/08; 05/Q0108/337
Submission date
27/07/2006
Registration date
22/09/2006
Last edited
24/05/2013
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Respiratory
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 Vilas Navapurkar
Scientific

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

Study information

Study designProspective, single centre, randomised controlled phase IV study employing a sequential statistical method.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymHOPE-DTSM
Study objectivesDo 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(s)Reviewed by Cambridge Research Ethics Committee and given favourable opinion on January 18th 2006 (reference number: 05/Q0108/337)
Health condition(s) or problem(s) studiedPost extubation respiratory failure or distress
Intervention24/05/2013: Please note that this trial was stopped on 01/08/2009

Subjects are randomised to either helium-oxygen or air-oxygen.
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase IV
Drug / device / biological / vaccine name(s)Helium-oxygen gas mixture
Primary outcome measureRe-ventilation rate at 24 hours.
Secondary outcome measuresPartial 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 study start date23/03/2009
Completion date23/03/2011
Reason abandoned (if study stopped)Lack of staff/facilities/resources

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsOver 100
Key inclusion criteriaAmended 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
Key exclusion criteriaAmended 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
Date of first enrolment23/03/2009
Date of final enrolment23/03/2011

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

John Farman Intensive Care Unit
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Box 277, Hills Road
Cambridge
CB2 0QQ
England
United Kingdom

http://www.cuh.org.uk/addenbrookes/addenbrookes_index.html
ROR logo https://ror.org/04v54gj93

Funders

Funder type

Industry

BOC Medical (UK)

No information available

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
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