New Maneuver to Facilitate Fiberoptic Intubation for Difficult Airway

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

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.

Study Overview

• Status: Completed
• Conditions: Anticipated Difficult Airway
• Intervention / Treatment: Other: Sham; Device: Fiberoptic Intubation; Other: Lingual Traction

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Fiberoptic Intubation Alone; Intubation with fiberoptic scope assistance	Other: Sham; Standard of care fiberoptic intubation without any additional experimental maneuvers; Device: Fiberoptic Intubation
Experimental: Fiberoptic Intubation with lingual traction; Intubation with fiberoptic scope assistance and lingual traction maneuver provided by a second anesthesiologist	Device: Fiberoptic Intubation; Other: Lingual Traction; The tongue pulling maneuver consists of grasping the tongue with 4x4cm gauze and gently pulling the tongue out until resistance is met.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Successful Intubations on First Attempt; Grade(s) Were Not Measured.	At Intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sore Throat Grade on First Postoperative Day	Patients will be asked to rate their sore throat qualitatively as none, mild, moderate, or severe	Postoperative day one

Collaborators and Investigators

• Sponsor: Enrico Camporesi
• Investigators: Study Director: Devanand Mangar, MD, Florida Gulf-to-Bay Anesthesiology

Publications and helpful links

General Publications

• Apfelbaum JL, Hagberg CA, Caplan RA, Blitt CD, Connis RT, Nickinovich DG, Hagberg CA, Caplan RA, Benumof JL, Berry FA, Blitt CD, Bode RH, Cheney FW, Connis RT, Guidry OF, Nickinovich DG, Ovassapian A; American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Practice guidelines for management of the difficult airway: an updated report by the American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Anesthesiology. 2013 Feb;118(2):251-70. doi: 10.1097/ALN.0b013e31827773b2. No abstract available.
• Peterson GN, Domino KB, Caplan RA, Posner KL, Lee LA, Cheney FW. Management of the difficult airway: a closed claims analysis. Anesthesiology. 2005 Jul;103(1):33-9. doi: 10.1097/00000542-200507000-00009.
• Umesh G, George M, Venkateswaran R. Tongue traction is as effective as jaw lift maneuver for Trachlight-guided orotracheal intubation. Acta Anaesthesiol Taiwan. 2010 Sep;48(3):130-5. doi: 10.1016/S1875-4597(10)60044-6.
• Rewari V, Ramachandran R, Trikha A. Lingual traction: a useful manoeuvre to lift the epiglottis in a difficult oral fibreoptic intubation. Acta Anaesthesiol Scand. 2009 May;53(5):695-6. doi: 10.1111/j.1399-6576.2009.01934.x. No abstract available.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: October 4, 2013
• First Submitted That Met QC Criteria: October 8, 2013
• First Posted (Estimate): October 9, 2013

Study Record Updates

• Last Update Posted (Estimate): September 12, 2016
• Last Update Submitted That Met QC Criteria: August 2, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: Pro00008289