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Monitoring of Non-invasive Ventilation

Monitoring of Non-invasive Ventilation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01845233
Enrollment
67
Registered
2013-05-03
Start date
2013-05-31
Completion date
2014-06-30
Last updated
2014-08-25

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

Conditions

Hypoventilation

Brief 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.

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.

Interventions

None listed

Sponsors

Haukeland University Hospital
CollaboratorOTHER
Trondheim University Hospital
CollaboratorOTHER
University Hospital, Geneva
CollaboratorOTHER
Oslo University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Frequency of transcutaneous co2 revealing sleep hypoventilation, when nocturnal pulseoximeter is normalsingle night study

Secondary

MeasureTime frame
Frequency of patient-ventilator asynchrony during non invasive ventilation ?Single night study

Other

MeasureTime frame
Comparing rate of event data from ventilator software with manually scored polygraphy during non invasive ventilationSingle night study
Technical drift of Transcutaneous Co2 measurement during 8 hours monitoringOne night study
Frequency of sleep related breathing events during non invasive ventilationsingle night study
Accuracy of Transcutaneous monitoring of Co2 compared to arterial carbon dioxide partial pressuresingle night study
Interscorer variability when scoring polygraphy during Non invasive ventilationone night study

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026