Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Patient -Ventilator Interaction in Chronic Respiratory Failure

This study has been completed.
Sponsor:
Collaborator:
Royal Brompton & Harefield NHS Foundation Trust
Information provided by (Responsible Party):
Michelle Ramsay, Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01371149
First received: June 9, 2011
Last updated: April 2, 2014
Last verified: April 2014

June 9, 2011
April 2, 2014
January 2011
January 2014   (final data collection date for primary outcome measure)
Adherence with ventilation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Data on patient reported compliance and ventilator recorded compliance will be collected.
Compliance with ventilation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Data on patient reported compliance and ventilator recorded complicance will be collected.
Complete list of historical versions of study NCT01371149 on ClinicalTrials.gov Archive Site
  • health related quality of life [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    SRI, RAND-36, visual analogue scores, St. George's respiratory questionnaire
  • length of hospital stay for initiation of home mechanical ventilation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • gas exchange [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    overnight oximetry, overnight capnography,arterial oxygenation, arterial carbon dioxide
Not Provided
Not Provided
Not Provided
 
Patient -Ventilator Interaction in Chronic Respiratory Failure
A Clinical Trial to Optimise Patient-ventilator Interaction in Patients With Chronic Respiratory Failure

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Hypercapnic Respiratory Failure
  • Obesity Hypoventilation Syndrome
  • Neuromuscular Disease
  • Chronic Obstructive Pulmonary Disease
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.
  • No Intervention: Physician led ventilator set up
    Patients will be set up on non-invasive ventilation as per the current gold standard physician led approach
  • Experimental: 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.
    Intervention: Other: Surface parasternal electromyography (EMG) set up
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
April 2014
January 2014   (final data collection date for primary outcome measure)

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.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01371149
10/H0716/67
No
Michelle Ramsay, Guy's and St Thomas' NHS Foundation Trust
Michelle Ramsay
Royal Brompton & Harefield NHS Foundation Trust
Not Provided
Guy's and St Thomas' NHS Foundation Trust
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP