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PSG Versus Oxim-capnography to Setup Home NIV

Sponsor
Guy's and St Thomas' NHS Foundation Trust (Other)
Overall Status
Completed
CT.gov ID
NCT02444806
Collaborator
University Hospital, Rouen (Other)
14
Enrollment
2
Arms
14
Duration (Months)

Study Details

Study Description

Brief Summary

The study aims to compare 2 different strategies used to setup non-invasive ventilation in patients with OCPD-OSA overlap.

Condition or Disease Intervention/Treatment Phase
  • Other: Full polysomnography
  • Other: Oximetry-capnography
 Phase 2

Detailed Description

With limited comparative data to support the different strategies, there is substantial variation across Europe and the United States in the methods used by clinicians to set up home non-invasive ventilation (NIV) for patients with chronic respiratory failure as a consequence of sleep disordered breathing. Indeed with few data to support the practice, many centres employ full montage polysomnography, which is not only a significant physical burden to the patient but also a financial burden to the healthcare provider in terms of the facilities required, staff training and equipment.

The investigators propose to undertake a randomised controlled trial to compare the clinical effectiveness, in terms of the change in daytime arterial partial pressure of carbon dioxide (PaCO2) at 3 months, of limited respiratory polygraphy and full polysomnography to set up NIV in patients with COPD-OSA overlap. Secondary outcome measures at 3 months will include overnight control of gas exchange, subjective sleep quality, health related quality of life and ventilator adherence. COPD-OSA overlap are a patient group that have a rising prevalence with limited data currently available detailing NIV set up, which wholly supports the rationale of using this increasingly important group as a target population for this trial.

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Clinical Effectiveness of PSG Versus Limited Respiratory Polygraphy During NIV Set up in COPD-OSA Overlap Syndrome: A Randomised Controlled Trial
Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Nov 1, 2015
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Full Polysomnography

Patients will have NIV settings established using overnight full polysomnography.

Other: Full polysomnography
Full sleep and respiratory monitoring with EEG
Other Names:
  • Polysomnography

    		•
    Active Comparator: Oximetry-capnography

    Patients will have NIV settings established using only Oximetry-capnography and subjective sleep comfort.

    Other: Oximetry-capnography
    Limited monitoring with nurse observation and continuous oximetry-capnography overnight for NIV titration.
    Other Names:
  • Limited respiratory monitoring

    		•

    Outcome Measures

    Primary Outcome Measures

    1. PaCO2 (Arterial blood gas analysis) [3 months]

      Arterial blood gas analysis

    Secondary Outcome Measures

    1. Health related quality of life (CAT, SRI) [3 months]

      CAT, SRI

    2. Spirometry (FEV1, FVC) [3 months]

      FEV1, FVC

    3. Subjective sleep comfort (VAS) [3 months]

      VAS

    4. Objective sleep comfort (Actigraphy) [3 months]

      Actigraphy

    5. Respiratory mechanics (to include, work of breathing, PEEPdyn, Cdyn, EMGdi, EMGpara) [Day 1]

      Invasive respiratory mechanics performed on discharge NIV settings to include, work of breathing, PEEPdyn, Cdyn, EMGdi, EMGpara

    6. NIV compliance (machine recorded) [3 months]

      NIV machine recorded compliance

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • COPD (as defined by GOLD criteria[4])

    • OSA (ODI > 7.5 events/hr, AHI > 5events/hr)

    • PaCO2 > 6 kPa

    • BMI > 30 kg/m2

    Exclusion Criteria:

    • Decompensated respiratory failure (pH < 7.35)

    • Inability to tolerate NIV (< 4 hours usage at in hospital titration)

    • Contraindication to NIV

    • Pregnancy

    • Aged <18

    • Significant physical or psychiatric co-morbidity that would prevent compliance with trial protocol

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Guy's and St Thomas' NHS Foundation Trust
    • University Hospital, Rouen

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guy's and St Thomas' NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT02444806
    Other Study ID Numbers:
    • 14/LO/2088
    First Posted:
    May 15, 2015
    Last Update Posted:
    Jul 12, 2016
    Last Verified:
    Jul 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Guy's and St Thomas' NHS Foundation Trust
    Sleep disordered breathing
    Domiciliary NIV

    Study Results

    No Results Posted as of Jul 12, 2016