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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03282604
Other study ID # 1-2017-0048
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 25, 2017
Est. completion date December 6, 2018

Study information

Verified date February 2019
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
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 the appropriateness of the tube depth and to suggest the ideal length of the nasotracheal tube during the intubation of the selected tracheal tube in consideration of the size of the nasal cavity in Koreans. 146 patients (73 males and 73 females) who are scheduled for nasal intubation for general anesthesia will be enrolled. The primary outcome is the ideal length of tube that allows the distance from the vocal cords to the proximal portion of the tube cuff to be greater than 2 cm and the tip of the intubated tube to be located 5 ± 2 cm above the tracheal carina. The size of nostril, length from the nare to the carina and vocal cord are measured.


Recruitment information / eligibility

Status Completed
Enrollment 146
Est. completion date December 6, 2018
Est. primary completion date December 6, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria:

1. Patients who are scheduled for nasotracheal intubation for general anesthesia

Exclusion Criteria:

1. age<20 years

2. ASA class III or more

3. pregnancy

4. emergency surgery

5. nasal airway disease

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

7. cervical movement disorder (cervical disease, cervical pain)

Study Design


Related Conditions & MeSH terms

  • Nasotracheal Intubation for General Anesthesia

Locations

Country Name City State
Korea, Republic of Department of Anesthesiology and Pain Medicine, Severance Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Han DW, Shim YH, Shin CS, Lee YW, Lee JS, Ahn SW. Estimation of the length of the nares-vocal cord. Anesth Analg. 2005 May;100(5):1533-5, table of contents. — View Citation

Reed DB, Clinton JE. Proper depth of placement of nasotracheal tubes in adults prior to radiographic confirmation. Acad Emerg Med. 1997 Dec;4(12):1111-4. — View Citation

Stoneham MD. The nasopharyngeal airway. Assessment of position by fibreoptic laryngoscopy. Anaesthesia. 1993 Jul;48(7):575-80. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary the ideal length of the nasotracheal tube during the intubation of the selected tracheal tube in consideration of the size of the nasal cavity in Koreans the ideal length of tube that allows the distance from the vocal cords to the proximal portion of the tube cuff to be greater than 2 cm and the tip of the intubated tube to be located 5 ± 2 cm above the tracheal carina. through study completion, an average of 1 year