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Completed

NCT Number: NCT01958346

New Maneuver to Facilitate Fiberoptic Intubation for Difficult Airway

We propose the additional technique of lingual traction or "tongue pulling" in conjunction with use of the flexible fiberoptic bronchoscope for facilitating successful first attempts at and decreasing time to intubation of the difficult airway and rescuing otherwise failed intubation attempts. Induction of general anesthesia causes relaxation and approximation of the soft palate, base of the tongue, epiglottis, and posterior pharyngeal wall, creating unfavorable anatomic changes in the pharynx for successful intubation. The use of lingual traction can assist in diminishing these problems by clearing the tongue away from the soft palate and uvula and lifting the epiglottis from the posterior pharyngeal wall, especially in the unanticipated difficult airway patient.

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Key information

Conditions

Anticipated Difficult Airway

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tampa General Hospital

Tampa, Florida, 33606, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • > 18 years old
  • With ASA (American Society of Anesthesiologists) physical status I-III
  • With anticipated difficult airway
  • Scheduled for elective surgery requiring orotracheal intubation (populations such as elective hip and knee arthroplasty patients)
  • Provide written consent

Exclusion criteria

  • With (American Society of Anesthesiologists) ASA physical status IV
  • Pregnant
  • Require rapid-sequence induction
  • Require a non-standard tracheal tub
  • Unable to provide written consent
  • At risk for pulmonary aspiration of gastric content

Treatment and study plan

Lingual Traction

Other

The tongue pulling maneuver consists of grasping the tongue with 4x4cm gauze and gently pulling the tongue out until resistance is met.

SHAM

Other

Standard of care fiberoptic intubation without any additional experimental maneuvers

Fiberoptic Intubation

Device

Primary outcomes

  1. Number of Participants With Successful Intubations on First Attempt; Grade(s) Were Not Measured.

    Time frame: At Intubation

Secondary outcomes

  1. Sore Throat Grade on First Postoperative Day

    Time frame: Postoperative day one

    Patients will be asked to rate their sore throat qualitatively as none, mild, moderate, or severe

Sponsors and collaborators

Lead sponsor

Enrico Camporesi

Other

Registry information

Official study title

New Maneuver to Facilitate Fiberoptic Intubation for Difficult Airway: A Prospective, Randomized Study

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 9, 2013
Registry last updated
Sep 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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