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Physiological Response to Heliox21 and Air O2

NCT01498432 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2011-12-23

No results posted yet for this study

Summary

This is a non-commercial study to explore the use of Heliox21 in a new patient cohort. The fundamental aim is to assess the therapeutic benefits of Heliox21 and practicalities of gas delivery in patients who require non-invasive ventilatory support following extubation on the Intensive Care Unit. Thus, the investigators aim to extend our knowledge of the potential role for Heliox21 in the post-extubation environment of the Intensive Care Unit. The purpose of this study is to answer a specific, clinically relevant question. That is whether Heliox21 helps to reduce the effort of breathing in the period following withdrawal of mechanically assisted ventilation in patients on the intensive care unit.

Conditions

  • Respiratory Insufficiency

Interventions

DRUG

Heliox21

For Heliox21 the percentage of O2 will match the percentage of O2 prior to extubation, and Helium will make up the remainder (e.g. Helium 65% + O2 35%), and the O2 concentration will be titrated as their clinical condition indicates (as O2 increases Helium will decrease and vice versa).

DRUG

Air O2

For Air-O2 the percentage of O2 delivered will match the patient's percentage of O2 prior to extubation, and will be titrated as their clinical condition indicates.

Sponsors & Collaborators

  • University College, London

    lead OTHER

Principal Investigators

  • Chris Hargreaves · Whittington Hospital NHS Trust

  • Daniel S Martin · University College, London

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-01-31
Completion
2013-04-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01498432 on ClinicalTrials.gov