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CompletedNCT03282604Updated Feb 12, 2019

The Ideal Length of the Nasotracheal Tube Considering Nasotracheal Tube Size

An observational study in Nasotracheal Intubation for General Anesthesia, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-02-12.

Sponsored by Yonsei University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
146
Ages
20 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Nasotracheal Intubation for General Anesthesia

Keywords

  • Intubation
  • Intratracheal
  • Nasopharynx
03

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who are scheduled for nasotracheal intubation for general anesthesia

Inclusion criteria

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

Exclusion criteria

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)
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
146 participants (actual)
Patient registry
No

Groups and cohorts

  • male
  • female
05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: through study completion, an average of 1 year

06

Study locations

1 site
  • Department of Anesthesiology and Pain Medicine, Severance
    Seoul, 03722, Korea, Republic of
07

References and documents

Publications

  • Stoneham MD. The nasopharyngeal airway. Assessment of position by fibreoptic laryngoscopy. Anaesthesia. 1993 Jul;48(7):575-80. doi: 10.1111/j.1365-2044.1993.tb07119.x. PubMed 8346770 ↗
  • 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. doi: 10.1111/j.1553-2712.1997.tb03691.x. PubMed 9408424 ↗
  • 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):1533-1535. doi: 10.1213/01.ANE.0000149900.68354.33. PubMed 15845720 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03282604
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Sep 14, 2017
Start date
Sep 25, 2017
Primary completion
Dec 6, 2018
Completion
Dec 6, 2018
Last update
Feb 12, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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