Assessment of a Properly Video Stylet Angulation for Orotracheal Intubation

NCT ID: NCT04735250

Last Updated: 2021-02-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-25
• Study Completion Date: 2022-07-31

Brief Summary

Uses the video stylet with different angulation to assist the orotracheal tube passing the oral cavity, oropharynx and advanced into the trachea

Detailed Description

In the patients receiving general anesthesia with nasotracheal or orotracheal intubation is common. However, a orotracheal tube blindly passing through the oral cavity and oropharynx may easily result in oral cavity and oropharynx damages.

The advancement of the tube from oropharynx into trachea may assist using the video stylet.

The aim of the study is to investigate use which angulation including 45 degree, 70 degree and 90 degree is appropriate to assist the orotracheal tube passing the oral cavity, oropharynx, and advanced into the trachea.

Patients are randomized into three groups by 45 degree, 70 degree and 90 degree to facilitate orotracheal tube sliding through into trachea and compared with each other group. Hemodynamic changes in each time interval, each time taken of tube going through the oral cavity, tube advanced from oropharynx into trachea will be recorded.

The incidence of using the video stylet with different angulation to accurately place tube tip into trachea, intubation related side effects and complications are recorded at postoperative time stages.

Conditions

Intubation Complication

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

45° group

Uses the video stylet with 45 degree(The tip of the trachway in 45°-55°) to assist the orotracheal tube passing the oral cavity, oropharynx and advanced into the trachea

No interventions assigned to this group

70° group

Uses the video stylet with 70 degree(The tip of the trachway in 60°-70°) to assist the orotracheal tube passing the oral cavity, oropharynx and advanced into the trachea

No interventions assigned to this group

90° group

Uses the video stylet with 90 degree(The tip of the trachway in 80°-90°) to assist the orotracheal tube passing the oral cavity, oropharynx and advanced into the trachea

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• undergoing surgery with general anesthesia(GA)
• ASA(American Society of Anesthesiologists):Ι to III
• 20 to 65 years old
• mouth Open > 3 cm
• the systemic disease exclusion
• conscious clear and without major Neurocognitive Disorder
• Mandarin or Taiwanese speaker
• agree the purpose of the study and sign the ICF

Exclusion Criteria

• difficult airway assessment [limited mouth opening < 3cm, limited neck motion(thyromental distance < 6cm)]
• previous head neck surgery history, oral and respiratory tract tumors, oral infections, neck disease, loosen tooth
• morbid obesity
• reject to participate

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chia-Heng Lin, MD

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chia-Heng Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital

Locations

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Sanmin District, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chia-Heng Lin, MD

Role: CONTACT

linsofar@yahoo.com.tw

88673121101 ext. 7035

Kuang-I Cheng, MD, PhD

Role: CONTACT

kuaich@kmu.edu.tw

88673121101 ext. 7035

Facility Contacts

Chia-Heng Lin, MD

Role: primary

linsofar@yahoo.com.tw

88673121101 ext. 7035

Other Identifiers

KMUHIRB-F(II)-20200132

Identifier Type: -

Identifier Source: org_study_id