NCT02876913

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 24, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

August 24, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2017

Completed
Last Updated

September 6, 2017

Status Verified

September 1, 2017

Enrollment Period

10 months

First QC Date

August 16, 2016

Last Update Submit

September 4, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Group Nasotracheal Intubation

Patients who are scheduled for nasotracheal intubation for general anesthesia

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are scheduled for nasotracheal intubation for general anesthesia

You may qualify if:

  • Patients who are scheduled for nasotracheal intubation for general anesthesia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

Related Publications (1)

  • Lee B, Park WK, Yun SY, Kang S, Kim HJ. Insertion depth of nasotracheal tubes sized to fit the nostril: an observational study. J Int Med Res. 2019 Jan;47(1):235-243. doi: 10.1177/0300060518800105. Epub 2018 Dec 16.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2016

First Posted

August 24, 2016

Study Start

August 24, 2016

Primary Completion

June 23, 2017

Study Completion

June 23, 2017

Last Updated

September 6, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations