Evaluation on the Proper Size of the Nasotracheal Tube and Depth in Nasotracheal Intubation: a Preliminary Study
1 other identifier
observational
40
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2016
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2016
CompletedFirst Posted
Study publicly available on registry
August 24, 2016
CompletedStudy Start
First participant enrolled
August 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 23, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 23, 2017
CompletedSeptember 6, 2017
September 1, 2017
10 months
August 16, 2016
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
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
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.
PMID: 30556457DERIVED
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