Transcutaneous CO2 Measurement - From Hospital to Home

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: Hypercapnic Respiratory Failure; Type 2 Respiratory Failure
• Intervention / Treatment: Diagnostic test: Transcutaneous CO2 monitoring

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

Study Locations

• Norway
  • Oslo, Norway
    • Oslo University Hospital

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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	January 1st 2020 - December 31st 2022

Collaborators and Investigators

• Sponsor: University of Oslo
• Collaborators: Oslo University Hospital
• Investigators: Study Director: Sigurd Aarrestad, Dr.med, Oslo University Hospital

Study record dates

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: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• 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