Cardiac and Respiratory Function With Non-invasive Ventilation

NCT02699112 | Completed

• 1 other identifier: 179324
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

To assess patients with hypercapnic respiratory failure using echocardiography,cardiac output measurements and markers of neural respiratory drive (EMGpara) prior to, during and after non-invasive ventilation (NIV) initiation, and to follow the patients for 3 months. The investigators hypothesize that the improvement in cardiac function and/or respiratory mechanics over time are associated with ongoing improvements in oxygenation, quality of life and exercise capacity.

Conditions

OHS; Hypercapnic Respiratory Failure

Outcome Measures

Primary Outcomes (2)

• Patients commencing on Non Invasive Ventilation (NIV); change in Cardiac Function from baseline and at 3 months

  Patients with hypercapnic respiratory failure caused by obesity hypoventilation syndrome commencing on NIV; change in cardiac function using echocardiography at baseline and 3 months. Measurements taken prior to NIV initiation, and follow up at 3 months.

  3 months

• Patients commencing on Non Invasive Ventilation (NIV); change on Nueral Respiratory Drive (NRD) from baseline and at 3 months

  Patients with hypercapnic respiratory failure caused by obesity hypoventilation syndrome commencing on NIV; change in markers of nerual respiratory drive/EMG para. Measurements taken prior to, and after NIV initiation, and follow up at 3 months.

  3 months

Secondary Outcomes (7)

• Patients commencing on Non Invasive Ventilation (NIV); change in Oxygenation from baseline, 6 weeks post initiation and at 3 months

  3 months

• Patients commencing on Non Invasive Ventilation (NIV); change in Quality of Life from baseline, 6 weeks post initiation and at 3 months

  3 months

• Patients commencing on Non Invasive Ventilation (NIV); change in Quality of Life from baseline, 6 weeks post initiation and at 3 months

  3 months

• Patients commencing on Non Invasive Ventilation (NIV); change in Quality of Life from baseline, 6 weeks post initiation and at 3 months

  3 months

• Patients commencing on Non Invasive Ventilation (NIV); change in Quality of Life from baseline, 6 weeks post initiation and at 3 months

  3 months

Interventions

Parasternal EMG (EMGpara) and Transthoracic Echocardiography OTHER

OHS patients recruited will have EMGpara and Transthoracic Echocardiography at admission and when established on NIV at 3 months.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting with a confirmed diagnosis of OHS and Overlap Syndrome and hypercapnic respiratory failure with the clinical intervention to commence on NIV will be invited to participate in the trial.

You may qualify if:

• Confirmed diagnosis of OHS and Overlap Syndrome
• Hypercapnic respiratory failure with the need to commence NIV
• Expected to remain an inpatient for ≥ 24 hours
• Age ≥ 18 and \<80 years
• BMI \>30 kg/m2
• Confirmed sleep-disordered breathing
• Able to give informed consent to participation in the evaluation study
• Clinically stable without exacerbations for ≥ 6 weeks

You may not qualify if:

• Patients established on NIV
• Inability to tolerate NIV (\< 4 hours usage at during hospital titration)
• Contraindication to NIV
• Requirement for immediate invasive mechanical ventilation at admission or any other acute critical illness
• Acute infective exacerbation
• Presence of other acute pathology or critical illness (such as pulmonary embolism)
• Presence of acute or chronic Left ventricular Cardiac Failure
• Significant Kidney or Liver disease
• Significant Anaemia
• History of Pulmonary Embolism in the previous 2 years
• Presence of cardiac congenital disease
• Presence of Primary Pulmonary Hypertension
• Presence of other severe medical problem, e.g. cancer and systemic connective tissue disease and vasculitides
• Pregnancy
• Psychological and social factors that would impair compliance with the evaluation

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• University of Padova: collaborator
• King's College London: collaborator
• Lane Fox Respiratory: collaborator

Study Sites (1)

Guys and St Thomas NHS Foundation

London, SE1 7EH, United Kingdom

Location

Related Links

• JTD publication

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Joerg Dr Steier

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Marino Dr Phil

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: March 4, 2016
• Study Start: November 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: April 11, 2018

Record last verified: 2018-04

Locations

GB (1)