Monitoring of Non-invasive Ventilation

NCT01845233 | Completed

• 1 other identifier: 2012/1142(REK)
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoventilation

Outcome Measures

Primary Outcomes (1)

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

  single night study

Secondary Outcomes (1)

• Frequency of patient-ventilator asynchrony during non invasive ventilation ?

  Single night study

Other Outcomes (5)

• Technical drift of Transcutaneous Co2 measurement during 8 hours monitoring

  One night study

• Interscorer variability when scoring polygraphy during Non invasive ventilation

  one night study

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

  Single night study

Study Arms (1)

Non invasive ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic hypoventilation treated with long term mechanical ventilation

You may not qualify if:

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

Sponsors & Collaborators

• Oslo University Hospital: lead
• Haukeland University Hospital: collaborator
• Trondheim University Hospital: collaborator
• University Hospital, Geneva: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Oslo County, 0471, Norway

Location

Related Publications (3)

• 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.

  PMID: 30366581 DERIVED

• 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.

  PMID: 29229100 DERIVED

• 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.

  PMID: 26874895 DERIVED

MeSH Terms

Conditions

Hypoventilation

Condition Hierarchy (Ancestors)

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

Study Officials

• Sigurd aarrestad, MD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2013
• First Posted: May 3, 2013
• Study Start: May 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 25, 2014

Record last verified: 2014-08

Locations

NO (1)