Evaluation on the Proper Size of the Nasotracheal Tube and Depth in Nasotracheal Intubation: a Preliminary Study

Nasotracheal Intubation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02876913
• Other study ID #: 4-2016-0504
• Status: Completed
• Phase: N/A
• First received: August 16, 2016
• Last updated: September 4, 2017
• Start date: August 24, 2016
• Est. completion date: June 23, 2017

Study information

• Verified date: September 2017
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The nasotracheal intubation is preferred for oral surgery; it provides an easier view of the surgical field. However, nasotracheal tubes are produced by foreign countries. Tubes are often not fitted in anatomy of Korean people because of small nostril. When the size of the tube is chosen by nostril size, the length of nasotracheal tube is not appropriate to the glottis. The aim of this study is to evaluate on the proper size of the nasotracheal tube and depth in nasotracheal intubation in Korean. Forty patients (20 males and 20 females) who are scheduled for nasal intubation for general anesthesia will be enrolled. The primary outcome is the proportion of patients who are in inappropriate insertion of nasotracheal tube; the proximal end of tube's cuff is less than 2 cm below vocal cord. The size of nostril, length from the nare to the carina and vocal cord are measured.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 23, 2017
• Est. primary completion date: June 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients who are scheduled for nasotracheal intubation for general anesthesia

Exclusion Criteria:

• age < 20 years and age > 70 years

• ASA(American Society of Anesthesiologist) class III or more

• pregnancy

• emergency surgery

• nasal airway disease

• expected difficult intubation (difficult intubation history, Modified Mallampati score 4, mouth opening <2cm, facial anomaly)

• unstable teeth

Related Conditions & MeSH terms

• Nasotracheal Intubation

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of the inappropriate insertion of nasotracheal tube	the inappropriate insertion of nasotracheal tube; the proximal end of tube's cuff is less than 2 cm below vocal cord	5 minutes after induction of general anesthesia