Physiological Response to Heliox21 and Air O2

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by University College, London.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT01498432
First received: December 20, 2011
Last updated: December 22, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Respiratory Insufficiency
Drug: Heliox21
Drug: Air O2
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Phase 4, Single Centre, Single Blinded,Prospective Randomised Cross Over Comparison on the Physiological Response of Post Extubation Intensive Care Patients to Non-invasive Ventilation Using Either Air O2 or Heliox21

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • The difference between the f/VT ratio* [ Time Frame: After four hours of Heliox21 and after four hours of Air O2. ] [ Designated as safety issue: No ]
    *f/VT is the measurement of breathing rate to tidal volume (f/VT) ratio


Estimated Enrollment: 38
Study Start Date: January 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Heliox21 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).
Active Comparator: Air O2 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.

Detailed Description:

Failure to wean from mechanical ventilatory support occurs when the magnitude of respiratory system loading exceeds its capacity to respond. Extubation success depends on the condition being resolved or improved. Gas exchange capacity, respiratory muscle strength, laryngeal function and cough strength, nutritional status and psychological state can all lead to extubation failure. However, efforts to reduce the work of breathing might offer an alternative strategy.

Studies recently carried out in both paediatric and adult populations disclose the serious consequences of failed extubation, namely prolonged intensive care and hospital stays, greater mortality rates and increased care costs.

Gas flow in an airway can be either laminar or turbulent. There needs to be a greater pressure differential to drive a turbulent flow than a laminar one. Helium is an inert gas with no systemic biological effects (at standard temperature and pressure).

The low density and viscosity of Helium means that its substitution for nitrogen in air allows laminar flow to be maintained at much higher flow rates, and flow rates to be maintained at much lower working pressures (5). As a result, the use of helium-oxygen mixtures (Heliox21) has potential to reduce work of breathing, and also to limit dynamic gas trapping through increased cavity emptying, and altered lung mechanics/ forced expiratory pressures. As a result, Heliox21 has been used as a respiratory therapeutic bridge for over 30 years, with demonstrable advantage in the management of conditions including tracheal obstruction and chronic obstructive pulmonary disease (COPD).

In theory, the use of Heliox21 should reduce work of breathing by improving the balance between work demand and capacity during the process of weaning patients from mechanical ventilation. In general studies of the use of Heliox21 after extubation have been limited. Thus, we aim to extend our knowledge of the potential role for Heliox21 in the post-extubation environment of the Intensive Care Unit. Whilst Heliox21 has generally been administered through a simple face-mask (+/- rebreathing bag), the development of the HAMILTON G5 AVEA ventilator now allows the accurate administration of Heliox21 (21% helium/79% oxygen) with defined inspired fractional oxygen concentrations. This advent offers the means to safely administer helium as an adjunct to non-invasive ventilatory support.

Main inclusion criteria:

All patients with a predicted requirement for post extubation non-invasive ventilatory support continuous positive airway pressure/bilevel positive airway pressure/noninvasive ventilation(CPAP/BiPAP/NIV) will be eligible.

The primary outcome measure:

The difference between the frequency to tidal volume (f/VT) ratio* after four hours of Heliox21 and the f/VT ratio after four hours of Air O2.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adults aged ≥ 18 years
  2. Males
  3. Females
  4. Any patient requiring mechanical ventilation for 5 days or more and/or has a tracheostomy to assist weaning from mechanical ventilation who has one or more of following risk factors suggesting that they are at risk of needing post extubation continuous positive airway pressure (CPAP), BiLevel positive airway pressure (BiPAP) or non-invasive ventilation (NIV):

    • BMI of 28 or more
    • Underlying respiratory disease (including asthma, COPD and bronchiectasis) as documented in medical notes for this current hospital admission.
    • SpO2 < 95% on 35% FiO2 or more
    • Smoker
    • Ex-smoker less than 12 months
    • Ex-smoker 10 pack year* or more history * Pack year = (Number of cigarettes per day X Number of years) ÷ 20

Exclusion Criteria:

  1. Age < 18 years
  2. Patient/legal representative refusal or inability to consent
  3. Adults with learning disabilities/ dementia
  4. Any contraindication to non-invasive ventilation:

    Inability to use mask (trauma/surgery) Excessive secretions Haemodynamic instability/life threatening arrhythmia

  5. High risk of aspiration:

    • Impaired mental status (Detained under the Mental Health Act)
    • Un-co-operative/agitated patient
    • Life threatening refractory hypoxemia
    • Undrained pneumothorax
    • Bullae on X-Ray
    • Recent upper GI anastamosis
  6. Patients already enrolled in an interventional
  7. Females known to be pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01498432

Contacts
Contact: Daniel S Martin 02077940500 ext 35047 rmhadam@ucl.ac.uk
Contact: Paula M Meale 02077940500 ext 35047 rmhapmm@ucl.ac.uk

Locations
United Kingdom
Whittington Hospital NHS Trust
London, United Kingdom, N19 5NF
Sponsors and Collaborators
University College, London
Investigators
Study Director: Chris Hargreaves Whittington Hospital NHS Trust
Principal Investigator: Daniel S Martin University College, London
  More Information

No publications provided

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01498432     History of Changes
Other Study ID Numbers: 08/0339, 2009-009599-11
Study First Received: December 20, 2011
Last Updated: December 22, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 01, 2014