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Completed

NCT Number: NCT01845233

Monitoring of Non-invasive Ventilation

The purpose of this study is to determine whether clinical examination, report from ventilator software, nocturnal Sp02 and daytime arterial blood gas are sufficient as screening tools to reveal clinical relevant problems with patients receiving long term treatment with non invasive ventilation.

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Key information

Conditions

Hypoventilation Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital

Oslo, 0471, Norway

About this study

Patient with chronic hypoventilation with stable on long term treatment (LTMV) with non-invasive ventilation for at least 3 month taking part of our LTMV program will be included.

In addition to clinical examination,report from ventilator software, nocturnal Sp02 and daytime arterial blood gas all patients will be investigated with sleep polygraphy and transcutaneous Co2.

Who can participate

Healthy volunteers accepted: No

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

  • Admitted to our unit for optimal treatment of long term non invasive ventilation
  • Readmitted for control after 6-8 weeks
  • Then treated for at least 3 month with long term non invasive ventilation outside of hospital.
  • Informed written consent

Exclusion criteria

  • Under 18 years old
  • Lack of cooperation
  • Pregnant
  • Acute exacerbation last 3 month leading to hospital admission.
  • Change of treatment last 3 month

Treatment and study plan

Primary outcomes

  1. Frequency of transcutaneous co2 revealing sleep hypoventilation, when nocturnal pulseoximeter is normal

    Time frame: single night study

Secondary outcomes

  1. Frequency of patient-ventilator asynchrony during non invasive ventilation ?

    Time frame: Single night study

Other outcomes

  1. Technical drift of Transcutaneous Co2 measurement during 8 hours monitoring

    Time frame: One night study

  2. Interscorer variability when scoring polygraphy during Non invasive ventilation

    Time frame: one night study

  3. Comparing rate of event data from ventilator software with manually scored polygraphy during non invasive ventilation

    Time frame: Single night study

  4. Accuracy of Transcutaneous monitoring of Co2 compared to arterial carbon dioxide partial pressure

    Time frame: single night study

  5. Frequency of sleep related breathing events during non invasive ventilation

    Time frame: single night study

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Haukeland University Hospital
  • Trondheim University Hospital
  • University Hospital, Geneva

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 3, 2013
Registry last updated
Aug 25, 2014

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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