Prognosis in Patients With Chronic Respiratory Failure Receiving Domiciliary Noninvasive Positive Pressure Ventilation (NPPV)

Analysis of the Prognosis and Clinical Course in Patients With Chronic Respiratory Failure Receiving Domiciliary NPPV

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00905476

Enrollment

Registered

2009-05-20

Start date

2009-04-30

Completion date

2014-11-30

Last updated

2015-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Respiratory Failure

Keywords

NPPV, Prognosis, Health-related quality of life, Patient reported outcomes

Brief summary

The purposes of the present study are (1) to analyze baseline patient characteristics cross-sectionally, (2) to analyze the prognosis and its predictive factors, and (3) to examine longitudinal clinical course in patients with chronic respiratory failure receiving domiciliary NPPV.

Detailed description

Limited data are available about the prognosis and its predictive factors in patients with chronic respiratory failure receiving domiciliary NPPV. In addition, their health status, psychological status and sleep quality seem to be highly disturbed due to severe respiratory insufficiency. Therefore, in the present study, we aim to examine (1) contributive factors to health status based on baseline data, (2) whether patient reported measurements such as health status, dyspnea and psychological status would predict patient's future outcomes, and (3) how they would change for 3 years as compared to physiological measurements.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with chronic respiratory failure receiving domiciliary NPPV for more than 3 months

Exclusion criteria

* Uncontrolled severe comorbidities * Patients with tracheotomy.

Design outcomes

Primary

Measure	Time frame
Prognosis/Mortality	3 years

Secondary

Measure	Time frame
6 minute walking tests	At entry and every year for 3 years
Pulmonary function	At entry and every year for 3 years
Health status	At entry and every year for 3 years
Arterial blood gas	At entry and every year for 3 years
Psychological status	At entry and every year for 3 years
Sleep quality	At entry and every year for 3 years
Dyspnea	At entry and every year for 3 years

Countries

Japan

Outcome results