Status:
COMPLETED
Evaluating the Non-Inferiority of Airmod to Capnostream™35
Lead Sponsor:
Heroic Faith Medical Science Co., Ltd.
Collaborating Sponsors:
Elite BioMedical Consulting Inc.
Conditions:
Respiratory Rate
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
This study is a multi-center clinical study of non-invasive medical device in Taiwan. After pre-anaesthesia evaluation, subjects who are suitable for intravenous general anesthesia (IVG) and age 20 ye...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female with at least 20 years of age.
- Fit for intravenous general anesthesia (IVG) as assessed by pre-anesthesia evaluation.
Exclusion
- Presence of neck pain or injuries.
- Under the use of high-flow nasal cannula ventilation. Patients with advanced airway management equipment. (For instance, Supraglottic airway device, LMA, Endotracheal tube.) Some equipment, such as High Flow Nasal Cannula (HFNC), CPAP, suction machine, could continually make noise in the patient's airway, affecting auscultation and RR measurement.
- Unable to wear Airmod and Capnostream™35 device related accessories at the investigator's discretion.
- As a vulnerable population, including legal incapacity or evidence that a subject cannot understand the purpose and risks of the study, regardless of authorized representative support.
- Unwilling or unable to comply fully with study procedures (including non-toleration of the capnography cannula) due to any disease condition which can raise doubt about compliance and influencing the study outcome.
Key Trial Info
Start Date :
December 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2023
Estimated Enrollment :
284 Patients enrolled
Trial Details
Trial ID
NCT05263791
Start Date
December 16 2021
End Date
September 1 2023
Last Update
November 19 2024
Active Locations (3)
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1
En Chu Kong Hospital
New Taipei City, Taiwan, 237
2
MacKay Memorial Hospital
Taipei, Taiwan, 10491
3
Cathay General Hospital
Taipei, Taiwan, 106