Monitoring of Non-invasive Ventilation

August 22, 2014 updated by: Oslo University Hospital
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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

67

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0471
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic hypoventilation treated with long term mechanical ventilation

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Non invasive ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of transcutaneous co2 revealing sleep hypoventilation, when nocturnal pulseoximeter is normal
Time Frame: single night study
single night study

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency of patient-ventilator asynchrony during non invasive ventilation ?
Time Frame: Single night study
Single night study

Other Outcome Measures

Outcome Measure
Time Frame
Technical drift of Transcutaneous Co2 measurement during 8 hours monitoring
Time Frame: One night study
One night study
Interscorer variability when scoring polygraphy during Non invasive ventilation
Time Frame: one night study
one night study
Comparing rate of event data from ventilator software with manually scored polygraphy during non invasive ventilation
Time Frame: Single night study
Single night study
Accuracy of Transcutaneous monitoring of Co2 compared to arterial carbon dioxide partial pressure
Time Frame: single night study
single night study
Frequency of sleep related breathing events during non invasive ventilation
Time Frame: single night study
single night study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

University Hospital, Geneva
Haukeland University Hospital
Trondheim University Hospital

Investigators

  • Principal Investigator: Sigurd aarrestad, MD, Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

March 11, 2013

First Submitted That Met QC Criteria

May 1, 2013

First Posted (Estimate)

May 3, 2013

Study Record Updates

Last Update Posted (Estimate)

August 25, 2014

Last Update Submitted That Met QC Criteria

August 22, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/1142(REK)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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