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Completed

NCT Number: NCT00905476

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

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.

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Key information

Conditions

Chronic Respiratory Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NHO Minami-Kyoto Hospital, Jōyō, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Uncontrolled severe comorbidities
  • Patients with tracheotomy.

Treatment and study plan

Primary outcomes

  1. Prognosis/Mortality

    Time frame: 3 years

Secondary outcomes

  1. Health status

    Time frame: At entry and every year for 3 years

  2. Dyspnea

    Time frame: At entry and every year for 3 years

  3. Psychological status

    Time frame: At entry and every year for 3 years

  4. Sleep quality

    Time frame: At entry and every year for 3 years

  5. Pulmonary function

    Time frame: At entry and every year for 3 years

  6. Arterial blood gas

    Time frame: At entry and every year for 3 years

  7. 6 minute walking tests

    Time frame: At entry and every year for 3 years

Sponsors and collaborators

Lead sponsor

Kyoto University, Graduate School of Medicine

Other

Collaborators

  • Ministry of Health, Labour and Welfare, Japan

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
May 20, 2009
Registry last updated
Apr 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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