Transcutaneous CO2 Measurement - From Hospital to Home

NCT ID: NCT06694870

Last Updated: 2024-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

129 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients scheduled for LT-NIV follow-up at Oslo University Hospital, UllevÄl 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Respiratory Failure Hypercapnic Respiratory Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hospital

Transcutaneous monitoring in the hospital

Transcutaneous CO2 monitoring

Intervention Type DIAGNOSTIC_TEST

Transuctaneous CO2 monitoring

Home

Transcutaneous monitoring at home

Transcutaneous CO2 monitoring

Intervention Type DIAGNOSTIC_TEST

Transuctaneous CO2 monitoring

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transcutaneous CO2 monitoring

Transuctaneous CO2 monitoring

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Oslo University Hospital

OTHER

Sponsor Role collaborator

University of Oslo

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Marte Skogstad Allgot

Cand.med

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sigurd Aarrestad, Dr.med

Role: STUDY_DIRECTOR

Oslo University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Oslo University Hospital

Oslo, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

707967

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.