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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01371149
Other study ID # 10/H0716/67
Secondary ID
Status Completed
Phase Phase 2
First received June 9, 2011
Last updated April 2, 2014
Start date January 2011
Est. completion date April 2014

Study information

Verified date April 2014
Source Guy's and St Thomas' NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

To evaluate a novel advanced physiological monitoring system to improve nocturnal non-invasive ventilation (NIV) in Neuromuscular disease (NMD), Chest wall disease (CWD), Chronic Obstructive Pulmonary Disease (COPD) and Obesity Hypoventilation Syndrome (OHS) patients. By enhancing sleep comfort, adherence to ventilation will increase which, in turn, will improve ventilatory failure, quality of life and reduce length of admission during initiation of therapy. We aim to incorporate this technology into routine clinical practice.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date April 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility Inclusion Criteria:

1. Patients over the age of 16 years.

2. Patients with confirmed diagnosis of Duchenne Muscular dystrophy or Chronic Obstructive Pulmonary Disease or Obesity Hypoventilation Syndrome.

3. Patients with evidence of nocturnal hypoventilation with an arterial carbon dioxide partial pressure of >6.0 kPa in the morning.

4. Patients with evidence of hypercapnic respiratory failure with an arterial carbon dioxide partial pressure of >6.0 kPa during the day.

5. No prior domiciliary ventilation.

Exclusion Criteria:

1. Patients with other co-morbidities e.g. cancer or cardiac failure.

2. Patients with muscular weakness but an unconfirmed diagnosis of Duchenne Muscular Dystrophy, Obesity Hypoventilation Syndrome or Chronic Obstructive Pulmonary Disease.

3. Patients who have had an acute illness within the last 4 weeks prior to starting assessment for ventilation.

4. Patients who have an abnormal bleeding tendency (INR or APTTr >1.4 or platelets <100).

5. Patients with a psychological, social or geographical situation that would impair compliance with the project.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Surface parasternal electromyography (EMG) set up
Ventilation parameters will be manipulated and titrated according to physiological measurements including signal from parasternal EMG and patient- ventilator asynchrony.

Locations

Country Name City State
United Kingdom Guy's and St. Thomas' NHS Trust London
United Kingdom Royal Brompton Hospital London

Sponsors (2)

Lead Sponsor Collaborator
Michelle Ramsay Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adherence with ventilation Data on patient reported compliance and ventilator recorded compliance will be collected. 3 months No
Secondary health related quality of life SRI, RAND-36, visual analogue scores, St. George's respiratory questionnaire 3 month No
Secondary length of hospital stay for initiation of home mechanical ventilation 3 months No
Secondary gas exchange overnight oximetry, overnight capnography,arterial oxygenation, arterial carbon dioxide 3 months Yes
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