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NCT01845233 Clinical Trial

Monitoring of Non-invasive Ventilation

Hypoventilation Clinical Trial

Official title:
Monitoring of Non-invasive Ventilation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01845233
Other study ID # 2012/1142(REK)
Secondary ID
Status Completed
Phase N/A
First received March 11, 2013
Last updated August 22, 2014
Start date May 2013
Est. completion date June 2014

Study information
Verified date August 2014
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Medicines AgencyNorway: Norwegian Social Science Data ServicesNorway: Directorate of Health
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 67
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility - 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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (4)
Lead Sponsor Collaborator
Oslo University Hospital Haukeland University Hospital, Trondheim University Hospital, University Hospital, Geneva

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Other Technical drift of Transcutaneous Co2 measurement during 8 hours monitoring One night study No
Other Interscorer variability when scoring polygraphy during Non invasive ventilation one night study No
Other Comparing rate of event data from ventilator software with manually scored polygraphy during non invasive ventilation Single night study No
Other Accuracy of Transcutaneous monitoring of Co2 compared to arterial carbon dioxide partial pressure single night study No
Other Frequency of sleep related breathing events during non invasive ventilation single night study No
Primary Frequency of transcutaneous co2 revealing sleep hypoventilation, when nocturnal pulseoximeter is normal single night study No
Secondary Frequency of patient-ventilator asynchrony during non invasive ventilation ? Single night study No
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