PSG Versus Oxim-capnography to Setup Home NIV

The Clinical Effectiveness of PSG Versus Limited Respiratory Polygraphy During NIV Set up in COPD-OSA Overlap Syndrome: A Randomised Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: OSA; COPD
• Intervention / Treatment: Other: Full polysomnography; Other: Oximetry-capnography

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PaCO2 (Arterial blood gas analysis)	Arterial blood gas analysis	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health related quality of life (CAT, SRI)	CAT, SRI	3 months
Spirometry (FEV1, FVC)	FEV1, FVC	3 months
Subjective sleep comfort (VAS)	VAS	3 months
Objective sleep comfort (Actigraphy)	Actigraphy	3 months
Respiratory mechanics (to include, work of breathing, PEEPdyn, Cdyn, EMGdi, EMGpara)	Invasive respiratory mechanics performed on discharge NIV settings to include, work of breathing, PEEPdyn, Cdyn, EMGdi, EMGpara	Day 1
NIV compliance (machine recorded)	NIV machine recorded compliance	3 months

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Patout M, Arbane G, Cuvelier A, Muir JF, Hart N, Murphy PB. Polysomnography versus limited respiratory monitoring and nurse-led titration to optimise non-invasive ventilation set-up: a pilot randomised clinical trial. Thorax. 2019 Jan;74(1):83-86. doi: 10.1136/thoraxjnl-2017-211067. Epub 2018 Mar 30.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: May 12, 2015
• First Submitted That Met QC Criteria: May 14, 2015
• First Posted (Estimate): May 15, 2015

Study Record Updates

• Last Update Posted (Estimate): July 12, 2016
• Last Update Submitted That Met QC Criteria: July 11, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Sleep disordered breathing; Domiciliary NIV
• Other Study ID Numbers: 14/LO/2088

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided