WithdrawnNot Applicable

Sleep Ventilation for Patients With Advanced Hypercapnic COPD

Stopped: Trial was not initiated due to COVID19 pandemic

United States0Started 2020-09-30

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Signed informed consent prior to any study-mandated procedure.
✓. Male or female aged ≥ 18 years with advanced hypercapnic COPD
✓. FEV1 ≤ 50% predicted and
✓. Prolonged hypercapnia during the daytime, at rest, without O2 or ventilatory support, PaCO2 \> 52 mmHg on ABG (performed off of NIPPV), compensated with pH \> 7.30
✓. Willingness to use NIPPV treatment
✓. English speaking

What they're measuring

Time to readmission or death

Timeframe: within 12 months

Trial details

NCT IDNCT04210050

SponsorBeth Israel Deaconess Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01

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