New Maneuver to Facilitate Fiberoptic Intubation for Difficult Airway

NCT01958346 | Completed Results

• 1 other identifier: Pro00008289
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anticipated Difficult Airway

Outcome Measures

Primary Outcomes (1)

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

  At Intubation

Secondary Outcomes (1)

• Sore Throat Grade on First Postoperative Day

  Postoperative day one

Study Arms (2)

Fiberoptic Intubation Alone

SHAM COMPARATOR

Intubation with fiberoptic scope assistance

Other: Sham; Device: Fiberoptic Intubation

Fiberoptic Intubation with lingual traction

EXPERIMENTAL

Intubation with fiberoptic scope assistance and lingual traction maneuver provided by a second anesthesiologist

Other: Lingual Traction; Device: Fiberoptic Intubation

Interventions

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.

Fiberoptic Intubation with lingual traction

Sham OTHER

Standard of care fiberoptic intubation without any additional experimental maneuvers

Fiberoptic Intubation Alone

Fiberoptic Intubation DEVICE

Fiberoptic Intubation Alone; Fiberoptic Intubation with lingual traction

Eligibility Criteria

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

You may qualify if:

• \> 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Enrico Camporesi: lead

Study Sites (1)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Related Publications (4)

• 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.

  PMID: 15983454 BACKGROUND

• 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.

  PMID: 23364566 BACKGROUND

• 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.

  PMID: 20864061 BACKGROUND

• 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.

  PMID: 19419380 BACKGROUND

MeSH Terms

Interventions

salicylhydroxamic acid

Results Point of Contact

• Title: Devanand Mangar MD
• Organization: Teamhealth Anesthesia

devanandmangar@teamhealth.com

813-844-4434

Study Officials

• Devanand Mangar, MD

  Florida Gulf-to-Bay Anesthesiology

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: October 4, 2013
• First Posted: October 9, 2013
• Study Start: June 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: November 1, 2013
• Last Updated: September 12, 2016
• Results First Posted: September 12, 2016

Record last verified: 2016-08

Locations

US (1)