New Maneuver to Facilitate Fiberoptic Intubation for Difficult Airway

NCT ID: NCT01958346

Last Updated: 2016-09-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Anticipated Difficult Airway

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Fiberoptic Intubation Alone

Intubation with fiberoptic scope assistance

Group Type SHAM_COMPARATOR

Sham

Intervention Type OTHER

Standard of care fiberoptic intubation without any additional experimental maneuvers

Fiberoptic Intubation

Intervention Type DEVICE

Fiberoptic Intubation with lingual traction

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

Group Type EXPERIMENTAL

Lingual Traction

Intervention Type 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

Intervention Type DEVICE

Interventions

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Lingual Traction

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

Intervention Type OTHER

Sham

Standard of care fiberoptic intubation without any additional experimental maneuvers

Intervention Type OTHER

Fiberoptic Intubation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Enrico Camporesi

OTHER

Sponsor Role lead

Responsible Party

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Enrico Camporesi

Anesthesiologist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Devanand Mangar, MD

Role: STUDY_DIRECTOR

Florida Gulf-to-Bay Anesthesiology

Locations

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Tampa General Hospital

Tampa, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15983454 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23364566 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20864061 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19419380 (View on PubMed)

Other Identifiers

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Pro00008289

Identifier Type: -

Identifier Source: org_study_id

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