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
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