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.

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Key information

Conditions

Type 2 Respiratory Failure Hypercapnic Respiratory Failure Hypoventilation Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital

Oslo, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for both groups were:

LT-NIV treatment for at least 3 months,
that the monitoring was due to a scheduled follow-up appointment,
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:

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.

Treatment and study plan

Transcutaneous CO2 monitoring

Diagnostic Test

Transuctaneous CO2 monitoring

Primary outcomes

Success rate home vs hospital

Time frame: January 1st 2020 - December 31st 2022

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

Oslo University Hospital

Registry information

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Nov 19, 2024
Registry last updated: Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed