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The Efficacy and Safety of the Airway Opening Device with Automatic Position Adjustment

The Efficacy and Safety of the Airway Opening Device with Automatic Position Adjustment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047300
Enrollment
Unknown
Registered
2021-06-12
Start date
2020-12-04
Completion date
Unknown
Last updated
2022-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway

Interventions

90 degree angle of position (PA):Using the device to open the airway of participants and keep this state last for 30 minutes under 90° of PA
95 degree angle of PA:Using the device to open the airway of participants and keep this state last for 30 minutes under 95° of PA
100 degree angle of PA:Using the device to open the airway of participants and keep this state last for 30 minutes under 100° of PA
Intervention group:The device was used to open the airway of the same patient undergoing bronchoscopy at 90, 95 and 100 degrees of PA in random order

Sponsors

The First Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: The safety of the device in healthy adults: 1. Aged more than 18 years old; 2. Volunteers are generally in good health, with a clear consciousness, clear language, and cooperative behavior; 3. Signed written informed consent. The effectiveness and safety of the device in patients with bronchoscopy: 1. Aged more than 18 years; 2. plan to receive the bronchoscopy; 3. ASA I or II; 4. Patients with a clear mind, clear language, and cooperative behavior; 5. Signed written informed consent.

Exclusion criteria

Exclusion criteria: 1.The safety of the device in healthy adults: (1) Past cervical and/or temporomandibular joint fracture, dislocation, injury; (2) Past head and face surgery history or major illness; (3) Participating in any other research; (4) Refused to sign written informed consent. 2.The effectiveness and safety of the device in patients with bronchoscopy: (1) Patients who have the contraindications of bronchoscopy or plan to use the laryngeal mask in bronchoscopy; (2) BMI >= 28kg/m2; (3) Previous severe fracture, injury or disease of the cervical spine; (4) Previous dislocation, injury or surgery of the temporomandibular joint; (5) Previous have severe head and face disease or surgery; (6) Participating in any other clinical trials.

Design outcomes

Primary

MeasureTime frame
The incidence of adverse events;The Cormack-Lehane grade;

Secondary

MeasureTime frame
The vital signs of participants at 10 minutes before the start of the study;The vital signs of participants at 10 minutes after the end of the study;

Countries

China

Contacts

Public ContactYang Xiangmei

The First Affiliated Hospital of Chongqing Medical University

numei@126.com+86 13062359909

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026