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Patient -Ventilator Interaction in Chronic Respiratory Failure

Primary Purpose

Chronic Hypercapnic Respiratory Failure, Obesity Hypoventilation Syndrome, Neuromuscular Disease

Status

Completed

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

Surface parasternal electromyography (EMG) set up

About this trial

This is an interventional treatment trial for Chronic Hypercapnic Respiratory Failure

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients over the age of 16 years.
Patients with confirmed diagnosis of Duchenne Muscular dystrophy or Chronic Obstructive Pulmonary Disease or Obesity Hypoventilation Syndrome.
Patients with evidence of nocturnal hypoventilation with an arterial carbon dioxide partial pressure of >6.0 kPa in the morning.
Patients with evidence of hypercapnic respiratory failure with an arterial carbon dioxide partial pressure of >6.0 kPa during the day.
No prior domiciliary ventilation.

Exclusion Criteria:

Patients with other co-morbidities e.g. cancer or cardiac failure.
Patients with muscular weakness but an unconfirmed diagnosis of Duchenne Muscular Dystrophy, Obesity Hypoventilation Syndrome or Chronic Obstructive Pulmonary Disease.
Patients who have had an acute illness within the last 4 weeks prior to starting assessment for ventilation.
Patients who have an abnormal bleeding tendency (INR or APTTr >1.4 or platelets <100).
Patients with a psychological, social or geographical situation that would impair compliance with the project.

Sites / Locations

Guy's and St. Thomas' NHS Trust
Royal Brompton Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Physician led ventilator set up

parasternal electromyography (EMG) set up

Arm Description

Patients will be set up on non-invasive ventilation as per the current gold standard physician led approach

Ventilation parameters will be manipulated and titrated according to physiological measurements including signal from parasternal EMG and patient- ventilator asynchrony.

Outcomes

Primary Outcome Measures

Adherence with ventilation

Data on patient reported compliance and ventilator recorded compliance will be collected.

Secondary Outcome Measures

health related quality of life

SRI, RAND-36, visual analogue scores, St. George's respiratory questionnaire

length of hospital stay for initiation of home mechanical ventilation

gas exchange

overnight oximetry, overnight capnography,arterial oxygenation, arterial carbon dioxide

Full Information

NCT ID

NCT01371149

First Posted

June 9, 2011

Last Updated

April 2, 2014

Sponsor

Michelle Ramsay

Collaborators

Royal Brompton & Harefield NHS Foundation Trust

1. Study Identification

Unique Protocol Identification Number

NCT01371149

Brief Title

Patient -Ventilator Interaction in Chronic Respiratory Failure

Official Title

A Clinical Trial to Optimise Patient-ventilator Interaction in Patients With Chronic Respiratory Failure

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Michelle Ramsay

Collaborators

Royal Brompton & Harefield NHS Foundation Trust

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hypercapnic Respiratory Failure, Obesity Hypoventilation Syndrome, Neuromuscular Disease, Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Physician led ventilator set up

Arm Type

No Intervention

Arm Description

Patients will be set up on non-invasive ventilation as per the current gold standard physician led approach

Arm Title

parasternal electromyography (EMG) set up

Arm Type

Experimental

Arm Description

Ventilation parameters will be manipulated and titrated according to physiological measurements including signal from parasternal EMG and patient- ventilator asynchrony.

Intervention Type

Other

Intervention Name(s)

Surface parasternal electromyography (EMG) set up

Intervention Description

Ventilation parameters will be manipulated and titrated according to physiological measurements including signal from parasternal EMG and patient- ventilator asynchrony.

Primary Outcome Measure Information:

Title

Adherence with ventilation

Description

Data on patient reported compliance and ventilator recorded compliance will be collected.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

health related quality of life

Description

SRI, RAND-36, visual analogue scores, St. George's respiratory questionnaire

Time Frame

3 month

Title

length of hospital stay for initiation of home mechanical ventilation

Time Frame

3 months

Title

gas exchange

Description

overnight oximetry, overnight capnography,arterial oxygenation, arterial carbon dioxide

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients over the age of 16 years. Patients with confirmed diagnosis of Duchenne Muscular dystrophy or Chronic Obstructive Pulmonary Disease or Obesity Hypoventilation Syndrome. Patients with evidence of nocturnal hypoventilation with an arterial carbon dioxide partial pressure of >6.0 kPa in the morning. Patients with evidence of hypercapnic respiratory failure with an arterial carbon dioxide partial pressure of >6.0 kPa during the day. No prior domiciliary ventilation. Exclusion Criteria: Patients with other co-morbidities e.g. cancer or cardiac failure. Patients with muscular weakness but an unconfirmed diagnosis of Duchenne Muscular Dystrophy, Obesity Hypoventilation Syndrome or Chronic Obstructive Pulmonary Disease. Patients who have had an acute illness within the last 4 weeks prior to starting assessment for ventilation. Patients who have an abnormal bleeding tendency (INR or APTTr >1.4 or platelets <100). Patients with a psychological, social or geographical situation that would impair compliance with the project.

Facility Information:

Facility Name

Guy's and St. Thomas' NHS Trust

City

London

ZIP/Postal Code

SE1 7EH

Country

United Kingdom

Facility Name

Royal Brompton Hospital

City

London

ZIP/Postal Code

SW3 6NP

Country

United Kingdom

12. IPD Sharing Statement

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Patient -Ventilator Interaction in Chronic Respiratory Failure

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