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A comparison of Helium-oxygen mixture (Heliox) with an oxygen-air mixture in reducing the work of breathing during weaning from mechanical ventilation. - Heliox and weaning

Phase 1
Conditions
Patients admitted to the intensive care unit who are in the recovery phase of their illness and are weaning from mechanical ventilation.
Registration Number
EUCTR2005-003612-30-GB
Lead Sponsor
Barts and the London NHS Trust
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
0
Inclusion Criteria

Patient will be defined as ready for weaning with CPAP
ifFailed a spontaneous breathing trial
Pressure support ventilation < 10cmH2O
Underlying respiratory failure improving
No upper airway obstruction or bronchospasm
Not receiving continuous IV sedation
Not receiving vasoactive agents
FiO2 < 0.4 and
PEEP< 10 cm H2O and
Fully conscious

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Inadequate analgesia
Pregnancy
Participation in other intervention trials in the past 30 days
Refusal of consent from the patient or assent from the next of kin

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: This is a study to look at whether breathing Helium (which being much lighter than air is easier to breathe) and oxygen<br>makes breathing easier for patients, and therefore enables them to be helped off the support provided by breathing<br>machines (ventilator) in their recovery phase in the intensive care unit.;Secondary Objective: To measure a number of physical signs in the patient such as heart rate, rate of breathing and to see if breathing the<br>Helium-oxygen mixture makes breathing more easy.;Primary end point(s): The primary endpoint will be CO2 production, a recognised measure of work of breathing during weaning. <br><br>
Secondary Outcome Measures
NameTimeMethod
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