Transcutaneous CO2 Measurement - From Hospital to Home

November 15, 2024 updated by: Marte Skogstad Allgot, University of Oslo
Long-term non-invasive ventilation (LT-NIV) is the main treatment modality for chronic hypercapnic respiratory failure.To assess the adequacy of alveolar ventilation during sleep and potential sleep hypoventilation, nocturnal transcutaneous CO2 (PtcCO2) monitoring is necessary. There is an increased tendency to monitor patients at home, but there is a lack of robust data comparing the technical success rates between the home and inpatient setting of PtcCO2 monitoring. The primary aim of the current study was to evaluate the rate of successful nocturnal PtcCO2 monitoring in a home setting in a population of patients with chronic hypercapnic respiratory failure receiving LT-NIV. The secondary aim was to compare these data with PtcCO2 registrations performed during regular follow up of a similar population of patients in a hospital setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients scheduled for LT-NIV follow-up at Oslo University Hospital, Ullevål in the time-period January 2020 to December 2022 were prospectively identified. Follow-up monitoring occurred either at home or in the hospital. Two physicians blinded to the location of the monitoring, retrospectively classified the PtcCO2 as successful or unsuccessful, and identified the causes of failure for the latter.

Study Type

Observational

Enrollment (Actual)

129

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Demographics Total Subjects (n) 129 Male 76 (59.0%) Age (mean) 54,9 ±18.0 Diagnosis Neuromuscular disorders: 85 (65.9%) COPD 9 (7.0%) Obesity hypoventilation syndrome: 24 (18.6%) Restrictive: 11 (8.5%)

Description

Inclusion criteria for both groups were:

  1. LT-NIV treatment for at least 3 months,
  2. that the monitoring was due to a scheduled follow-up appointment,
  3. at least one follow-up visit at the hospital after LT-NIV initiation. Inclusion in the study required a signed consent from all participants.

There were three additional criteria for the home monitoring group:

  1. home address in reasonable proximity to the hospital,
  2. the subject/spouse/assistant/home health care provider was assumed capable of operating the equipment, and
  3. the subject consented to undertaking the monitoring at home.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hospital
Transcutaneous monitoring in the hospital
Diagnostic test: Transcutaneous CO2 monitoring
Transuctaneous CO2 monitoring
Home
Transcutaneous monitoring at home
Diagnostic test: Transcutaneous CO2 monitoring
Transuctaneous CO2 monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Success rate home vs hospital
Time Frame: January 1st 2020 - December 31st 2022
January 1st 2020 - December 31st 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oslo

Collaborators

Oslo University Hospital

Investigators

  • Study Director: Sigurd Aarrestad, Dr.med, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

November 15, 2024

First Submitted That Met QC Criteria

November 15, 2024

First Posted (Estimated)

November 19, 2024

Study Record Updates

Last Update Posted (Estimated)

November 19, 2024

Last Update Submitted That Met QC Criteria

November 15, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 707967

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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