Monitoring of Non-invasive Ventilation | NCT01845233

Studies
Monitoring of Non-invasive Ventilation

NCT01845233

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Aug 25, 2014Estimated

Enrollment

67Actual

Phase

Not provided

Conditions

Hypoventilation

Interventions

Not provided

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Mar 11, 2013

First Submission Date that Met QC Criteria

May 1, 2013

First Posted Date

May 3, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2014

Last Update Posted Date

Aug 25, 2014Estimated

Name	Class
Haukeland University Hospital	OTHER
Trondheim University Hospital	OTHER
University Hospital, Geneva	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

67Actual

Label	Type	Description	Intervention Names
Non invasive ventilation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Measure	Description	Time Frame
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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with chronic hypoventilation treated with long term mechanical ventilation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sigurd aarrestad, MD	Oslo University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo University Hospital		Oslo	Oslo	0471	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30366581	Derived	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.
29229100

ID	Term
D012131	Respiratory Insufficiency
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory