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Sleep Ventilation for Patients With Advanced Hypercapnic COPD

NCT04210050 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-01-04

No results posted yet for this study

Summary

Despite growing evidence showing benefit (in both clinical and cost standpoints), only a small percentage of COPD patients with chronic hypercapnic respiratory failure are managed with nocturnal ventilatory support. There is uncertainty of the value of aggressive nocturnal ventilation, especially polysomnographic estimation of therapy and home transcutaneous CO2 tracking.

The driving goal behind this project is to develop and implement a streamlined and comprehensive program for nocturnal ventilator management of patients with advanced, hypercapnic COPD.

Conditions

Interventions

DEVICE

Home noninvasive nocturnal ventilation with Breas VIVO 50 home ventilator or newer model as available, Breas Medical.

In the usual care plus NIPPV group, those able to undergo attended PSG will be titrated with volume targeted pressure support mode, aiming to lower the baseline TcCO2 by 10 mmHg. In some cases, the CO2 cannot be lowered by that amount on a single titration, but rather will decrease over time. For those unable to undergo lab titration (too frail, no transportation, decline/refuse), NIPPV will be initiated with empiric settings based on nighttime home CO2 tracking and daytime ABG monitoring.

DIAGNOSTIC_TEST

Arterial blood gas (ABG) and serum bicarbonate level

Will be obtained at baseline (before randomization), then at 3, 6 and 12 months into the study

DIAGNOSTIC_TEST

Overnight home oximetry and transcutaneous CO2 monitoring

will be conducted at 1 and 6 months into the study (for subjects in the NIPPV plus usual care group, testing will be done while using the ventilator.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-30
Primary Completion
2025-01-31
Completion
2026-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04210050 on ClinicalTrials.gov