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NCT03265938 · ClinicalTrials.gov registry record

Evaluation of Video Laryngoscopy in Patients With Head and Neck Pathology

A clinical trial, sponsored by Icahn School of Medicine at Mount Sinai.

Completed
Registry status
100
Enrollment target

NCT03265938: Completed study, sponsored by Icahn School of Medicine at Mount Sinai.

NCT03265938 is a clinical trial that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 100 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03265938 has completed, sponsored by Icahn School of Medicine at Mount Sinai.

COMPLETED
Registry status
100 participants
Enrollment target

Study Summary

Patients who undergo general anesthesia for surgical procedures frequently need to have a breathing tube placed ("tracheal intubation") for the duration of the procedure. Most often airway management is routine for an experienced anesthesiologist. Less often, airway management can be difficult and can result in patient harm. In order to reduce risk, anesthesiologists routinely evaluate patients' airways by obtaining a relevant history and doing a physical exam, which can aid in predicting which airways may be difficult to manage. The "gold standard" for management of the anticipated difficult airway is to perform an awake flexible bronchoscopic intubation after anesthetizing the airway with local anesthesia. This affords added safety because the airway remains patent and the patient breaths spontaneously until a tracheal tube is secured, at which point general anesthesia can be induced. Recently, authors have advocated for alternative methods of management of the predicted difficult airway, most commonly by using a video laryngoscope to perform the awake intubation. A video laryngoscope provides an indirect view of the larynx using a camera at the tip of a rigid laryngoscope. It takes less training to gain and maintain proficiency compared to flexible bronchoscopy. Previous studies that have shown successful awake intubation with video laryngoscopy in the predicted difficult airway have not included patients with head and neck pathology, including malignancies or a history of head and neck surgery or radiation. In this study, the study team will perform video laryngoscopy in patients with head and neck pathology who require awake bronchoscopic intubation for surgery after placement of the tracheal tube and induction of anesthesia. The study team hypothesize that it will be difficult to obtain a good view of the larynx with video laryngoscopy in some patients with head and neck pathology. If there is a significant incidence of difficult video laryngoscopy in this p

Primary Outcome

Number of participants with difficult (Cormack-Lehane grade \>2) video laryngoscopic view of the larynx after awake flexible bronchoscopic intubation in patients with head and neck pathology with CMAC Cormack-Lehane grade in patients with head and neck pathology of the larynx. Cormack-Lehane grade: Grade 1: full view of the glottis Grade 2a: partial view of the glottis Grade 2b: arytenoids only Grade 3: epiglottis only Grade 4: neither glottis or epiglottis identified

Interventions

  • DEVICE Indirect Laryngoscopy

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2017-09-13
Est. Completion 2019-07-24

What the finished NCT03265938 record still lists

NCT03265938 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 1 intervention - of which Indirect Laryngoscopy is the first listed.

NCT03265938 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03265938 about?

NCT03265938 is a clinical study titled "Evaluation of Video Laryngoscopy in Patients With Head and Neck Pathology". Patients who undergo general anesthesia for surgical procedures frequently need to have a breathing tube placed ("tracheal intubation") for the duration of the procedure. Most often airway management is routine for an experienced anesthesiologist. Less often, airway management can be difficult and c...

What is the current status of trial NCT03265938?

This trial is currently completed. The enrollment target is 100 participants. The study started on 2017-09-13. Estimated completion is 2019-07-24.

What interventions are being tested in trial NCT03265938?

The interventions under investigation include: Indirect Laryngoscopy (DEVICE).

Who is sponsoring clinical trial NCT03265938?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT03265938, the US trial registry maintained by the National Library of Medicine. NCT03265938 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.