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Not yet recruiting NCT06618625

Tube Rotation for Tube Passage Into the Oral Cavity in Nasotracheal Intubation

No phase Interventional Nasotracheal Intubation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: nasotracheal intubation.
Who it may be relevant to
Registry conditions: Nasotracheal Intubation. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effect of Tube Rotation on Passage of Tracheal Tube Through Nasopharynx Into the Oral Cavity in Nasotracheal Intubation

Overview

The purpose of the study is to investigate the effect of tube rotation on passage of the tracheal tube through the nasopharynx into the oral cavity in nasotracheal intubation.

Detailed description

This prospective randomized controlled study was approved by IRB of our institute.

Patients requiring nasotracheal intubation will be screened for eligibility of the study. Then, patients will be randomized to one of two groups; (group I: tube advancement in neutral / group II: tube advancement with the tube counter-clockwise rotated). After induction of anesthesia and muscle relaxation, the preformed nasal RAE (Ring-Adair-Elwyn) tube will be inserted via a nostril approximately 3-4 cm. Next, an anesthesiologist will advance the tube, with it neutral, continuously into the oral cavity of the patients in Group I, while the anesthesiologist will advance the tube, with it rotated counter-clockwise in 90 degree, into the oral cavity of the patients in Group II. After the tube will be placed in the oral cavity, the anesthesiologist will perform nasotracheal intubation with Magill forceps. After that, an investigator will check occurrence of epistaxis due to nasotracheal intubation and its severity with a fiberoptic bronchoscope. After obtainment of all data, investigators will analyze incidence of epistaxis and its severity between two groups.

Interventions

  • Procedure nasotracheal intubation
    For nasotracheal intubation, the nasal RAE tube will be inserted with it rotated by 90 degrees in counter-clockwise direction for patients in the 'Rotation' arm. For nasotracheal intubation, the nasal RAE tube will be inserted without tube rotation for patients in the 'Neutral' arm.

Primary outcome measures

  • tube blockade [Time frame: during tube advancement from the nasal cavity to the oral cavity]
Secondary outcome measures (1)
  • epistaxis [Time frame: during nasotracheal intubation]

Eligibility criteria

Inclusion criteria

  • adult patients requiring nasotracheal intubation for elective surgery

Exclusion criteria

  • refuse to participate in the study
  • severe deformity in nose
  • current severe epistaxis
  • limitation of neck extension

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Kim H, Lee JM, Lee J, Hwang JY, Chang JE, No HJ, Won D, Row HS, Min SW. Effect of neck extension on the advancement of tracheal tubes from the nasal cavity to the oropharynx in nasotracheal intubation: a randomized controlled trial. BMC Anesthesiol. 2019 Aug 17;19(1):158. doi: 10.1186/s12871-019-0831-6. PMID 31421677

Identifiers

NCT: NCT06618625 · 10-2023-61

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗