Clinical trial NCT01845233: Monitoring of Non-invasive Ventilation
Official title: Monitoring of Non-invasive Ventilation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoventilation
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
name: Trondheim University Hospital
name: University Hospital, Geneva
First posted: 2013-05-03
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic hypoventilation treated with long term mechanical ventilation

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.

Eligibility 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

Primary outcomes:
measure: Frequency of transcutaneous co2 revealing sleep hypoventilation, when nocturnal pulseoximeter is normal
timeFrame: single night study
Secondary outcomes:
measure: Frequency of patient-ventilator asynchrony during non invasive ventilation ?
timeFrame: Single night study
Other outcomes:
measure: Technical drift of Transcutaneous Co2 measurement during 8 hours monitoring
timeFrame: One night study
measure: Interscorer variability when scoring polygraphy during Non invasive ventilation
timeFrame: one night study
measure: Comparing rate of event data from ventilator software with manually scored polygraphy during non invasive ventilation
timeFrame: Single night study
measure: Accuracy of Transcutaneous monitoring of Co2 compared to arterial carbon dioxide partial pressure
timeFrame: single night study
measure: Frequency of sleep related breathing events during non invasive ventilation
timeFrame: single night study
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Sigurd aarrestad, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aarrestad S, Qvarfort M, Kleiven AL, Tollefsen E, Skjonsberg OH, Janssens JP. Diagnostic accuracy of simple tools in monitoring patients with chronic hypoventilation treated with non-invasive ventilation; a prospective cross-sectional study. Respir Med. 2018 Nov;144:30-35. doi: 10.1016/j.rmed.2018.09.015. Epub 2018 Sep 26.
citation: Aarrestad S, Qvarfort M, Kleiven AL, Tollefsen E, Skjonsberg OH, Janssens JP. Sleep related respiratory events during non-invasive ventilation of patients with chronic hypoventilation. Respir Med. 2017 Nov;132:210-216. doi: 10.1016/j.rmed.2017.10.025. Epub 2017 Nov 2.
citation: Aarrestad S, Tollefsen E, Kleiven AL, Qvarfort M, Janssens JP, Skjonsberg OH. Validity of transcutaneous PCO2 in monitoring chronic hypoventilation treated with non-invasive ventilation. Respir Med. 2016 Mar;112:112-8. doi: 10.1016/j.rmed.2016.01.017. Epub 2016 Jan 27.