Transcutaneous CO2 Measurement - From Hospital to Home

NCT06694870 | Completed DMC

• 1 other identifier: 707967
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Respiratory Failure; Hypercapnic Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Success rate home vs hospital

  January 1st 2020 - December 31st 2022

Study Arms (2)

Hospital

Transcutaneous monitoring in the hospital

Diagnostic Test: Transcutaneous CO2 monitoring

Home

Transcutaneous monitoring at home

Diagnostic Test: Transcutaneous CO2 monitoring

Interventions

Transcutaneous CO2 monitoring DIAGNOSTIC_TEST

Transuctaneous CO2 monitoring

Home; Hospital

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

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%)

You may qualify if:

• LT-NIV treatment for at least 3 months,
• that the monitoring was due to a scheduled follow-up appointment,
• There were three additional criteria for the home monitoring group:
• home address in reasonable proximity to the hospital,
• the subject/spouse/assistant/home health care provider was assumed capable of operating the equipment, and
• the subject consented to undertaking the monitoring at home.

Sponsors & Collaborators

• University of Oslo: lead
• Oslo University Hospital: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

MeSH Terms

Conditions

Hypoventilation; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

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

Study Officials

• Sigurd Aarrestad, Dr.med

  Oslo University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cand.med

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 19, 2024
• Study Start: January 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)