PSG Versus Oxim-capnography to Setup Home NIV

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02444806
• Other study ID #: 14/LO/2088
• Status: Completed
• Phase: Phase 2
• First received: May 12, 2015
• Last updated: July 11, 2016
• Start date: January 2015
• Est. completion date: March 2016

Study information

• Verified date: July 2016
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• OSA

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	University Hospital, Rouen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PaCO2 (Arterial blood gas analysis)	Arterial blood gas analysis	3 months	Yes
Secondary	Health related quality of life (CAT, SRI)	CAT, SRI	3 months	No
Secondary	Spirometry (FEV1, FVC)	FEV1, FVC	3 months	No
Secondary	Subjective sleep comfort (VAS)	VAS	3 months	No
Secondary	Objective sleep comfort (Actigraphy)	Actigraphy	3 months	No
Secondary	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	No
Secondary	NIV compliance (machine recorded)	NIV machine recorded compliance	3 months	No