Cuff Inflation-supplemented Videoscope-guided Nasal Intubation

NCT03136549 | Completed

• 1 other identifier: 2017-03-020
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Epistaxis or post-pharyngeal bleeding is the most common complication after nasotracheal intubation (NTI). Prior thermal softening of the endotracheal tube (ET) has been recommended as one of the methods to prevent nasal trauma from nasotracheal intubation. However, thermal softening of tubes tends to adversely affect the nasotracheal navigation of the ET. During NTI under conventional direct laryngoscopy, the tip of the Macintosh laryngoscope is advanced into the vallecula, indirectly elevating the epiglottis by applying pressure on the hyoepiglottic ligament. Although this maneuver allows optimal visualization of the glottis, it lifts the larynx away from the tip of the advancing nasotracheal tube (NTT), which generally lies along the posterior pharyngeal wall. Most clinicians use Magill forceps to direct the tip of the NTT anteriorly to enter the glottis. Magill forceps may cause damage to the cuff of an ET or may injure oropharyngeal mucosa. The use of a video laryngoscope and a cuff inflation technique has been proposed as a method for reducing the malalignment of tubes. Indirect laryngoscopy using a Video laryngoscopy can reduce malalignment by minimizing lifting the glottis during laryngoscopy. The cuff inflation technique (wherein the cuff of ET tube is inflated with 15 mL of air) has been used while performing "blind" NTI to guide such malaligned polyvinyl chloride (PVC) ET tubes into the laryngeal inlet. Recently, one study reported that the cuff inflation technique consistently improved the oropharyngeal insertion of the different ET tubes of varying stiffness during direct laryngoscope-guided NTI. There has never been study about effect of cuff inflation technique on navigability when performing NTI under video laryngoscopy guidance with ET tubes of varying stiffness.Investigators assessed and compared the incidence of nasal injury and nasotracheal navigability with two technique during cuff inflation-supplemented NTI guided by video- laryngoscopy

Conditions

Nasotracheal Intubation

Outcome Measures

Primary Outcomes (1)

• severity of epistaxis

  The severity of epistaxis was evaluated under VL using a 4-point scale:no epistaxis; mild epistaxis (blood on the tracheal tube only); moderate epistaxis (blood pooling in the pharynx); or severe epistaxis (blood in the pharynx sufficient to impede intubation)

  during navigation from nose to oropharynx

Secondary Outcomes (5)

• the navigation of ET tube from nose to oropharynx

  during navigation from nose to oropharynx

• time

  The passage of each ET tube from nasal cavity to trachea was divided into 3 phases (phase 1: from the nose into oropharynx, phase 2: from oropharynx into the laryngeal inlet , phase 3: from the laryngeal inlet into the trachea)

• air volume

  during navigation from oropharynx to laryngeal inlet

• the navigation of ET tube from oropharynx to laryngeal inlet

  during navigation from oropharynx to the laryngeal inlet

• the navigation of ET tube from laryngeal inlet to trachea

  during navigation from laryngeal inlet to trachea

Study Arms (2)

Room temperature

PLACEBO COMPARATOR

The nasotracheal tube, sized 6.0 -7.0 mm inner diameter (ID), were put into a bottle of sterilized normal saline (1 L, 25 °C) at room temperature.

Other: Room temperature

Thermo-softening

EXPERIMENTAL

The naso tracheal tube, sized 6.0 -7.0 mm inner diameter (ID), were put into a bottle of sterilized normal saline (1 L) at warm cabinet set to 45°C (approximately 117°F).

Other: Thermo-softening

Interventions

Thermo-softening OTHER

The thermosoftening treatment of the tubes was performed by using a warm cabinet set to 45°C (approximately 117°F). One bottle of normal saline (1 L) containing a thermometer and three tubes (6.0 -7.0 mm ID) was put into a chamber of the cabinet 30 min before intubation.

Thermo-softening

Room temperature OTHER

nasotracheal tube, sized 6.0 -7.0 mm inner diameter (ID), were put into a bottle of sterilized normal saline (1 L, 25 °C) at room temperature.

Room temperature

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA status I-III, older than 18 yr, who under went elective surgery and requiring ET intubation as part of anesthetic management were enrolled in the study.

You may not qualify if:

• Patients with bleeding diathesis, history of recurrent nasal obstruction or any nasal/pharyngeal surgery, and those with anticipated difficult tracheal intubation were excluded.

Sponsors & Collaborators

• Hallym University Kangnam Sacred Heart Hospital: lead

Study Sites (1)

Kangnam Sacred Heart Hospital, Hallym University College of Medicine

Seoul, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: May 2, 2017
• Study Start: June 10, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)