Clinical trial NCT03136549: Cuff Inflation-supplemented Videoscope-guided Nasal Intubation
Official title: Cuff Inflation-supplemented Videoscope-guided Nasal Intubation: The Effect of Tube Thermo-softening on the Nasotracheal Navigability
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nasotracheal Intubation
Lead sponsor: Hallym University Kangnam Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2017-05-02
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: severity of epistaxis
timeFrame: during navigation from nose to oropharynx
Secondary outcomes:
measure: the navigation of ET tube from nose to oropharynx
timeFrame: during navigation from nose to oropharynx
measure: time
timeFrame: 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)
measure: air volume
timeFrame: during navigation from oropharynx to laryngeal inlet
measure: the navigation of ET tube from oropharynx to laryngeal inlet
timeFrame: during navigation from oropharynx to the laryngeal inlet
measure: the navigation of ET tube from laryngeal inlet to trachea
timeFrame: during navigation from laryngeal inlet to trachea
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangnam Sacred Heart Hospital, Hallym University College of Medicine
Study officials:
References: