N/A
N=29
A Comparison of Capnography Sampling Lines
Capnography
Bottom Line
View on ClinicalTrials.gov: NCT03554629 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Capnography Measured CO2 Waveform Data as a Function of CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity — 30.6; 0.0; 26.6; 0.2 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Capnography CO2 cannula sampling Flexiterline (CCSF) designs with supplemental O2 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Capnography Measured CO2 Waveform Data as a Function of CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity |
30.6; 0.0; 26.6; 0.2; 20.1; 0.1 | — |
| SECONDARY Average Number of Alarms as a Function of Each Capnography CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity With an Actual Respiration Rate of 24 |
0.17; 0.13; 0.35; 0.30; 0.17; 0.15 | — |
| SECONDARY Average Number of Alarms as a Function of Each Capnography CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity With an Actual Respiration Rate of 6 |
0.13; 0.09; 0.24; 0.22; 0.30; 0.24 | — |
Summary
This study evaluates the performance of eight (8) cleared capnography carbon dioxide (CO2) sampling filterlines during patient simulated scripted activities when connected to a Medtronic (MDT) dual parameter monitor.
Eligibility Criteria
Inclusion Criteria
- Non-hospitalized adults ≥ 18 years old.
- Willing and able to give informed consent.
Exclusion Criteria
- Lack of an informed consent.
- Subjects not able to accommodate the proper application of the cannula.
- Subject not willing or able to comply fully with the study procedures.
- Subjects with sensitivity to nasal cannula in both nares.
- Subject with skin allergies to medical adhesives.
- Subjects with runny nose the day of the study participation.
- Subject, who in the opinion of the Principal Investigator, should not be enrolled.
Data sourced from ClinicalTrials.gov (NCT03554629). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.