Video-Laryngoscope Alone or With Bronchoscope for Predicted Difficult Intubation

NCT03080896 | Completed FDA Device

• 1 other identifier: IRB #15.0096
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Using a combination of the video-laryngoscope with the disposable fiber-optic bronchoscope (aScope III) is a feasible way to facilitate successful intubation in a timely manner, in patients with predicted difficult airway due to tumors in the oral cavity, pharynx or larynx To test the hypothesis that combination of video-laryngoscope with the fiber-optic bronchoscope is superior to video-laryngoscope alone for intubation of patients with oral cavity, pharyngeal or laryngeal pathologies undergoing surgery

Conditions

Intubation; Difficult

Outcome Measures

Primary Outcomes (1)

• Time to successful intubation

  measured in seconds

  From time full relaxation is achieved to time the patients is successfully intubated confirmed by breath sounds over a period of up to ten minutes

Secondary Outcomes (2)

• Conversion from control group to intervention group

  From the time full relaxation is achieved until the subject is successfully intubated confirmed by breath sounds over a period of up to ten minutes

• Number of intubation attempts until successful

  From the time full relaxation is achieved until the time the subject is intubated; confirmed with breath sounds over a period of up to ten minutes

Study Arms (2)

control group videolaryngoscope/preformed stylet

ACTIVE COMPARATOR

The control group will intubate using the video-laryngoscope / pre formed stylet. Will convert to using video-laryngoscope and fiber-optic bronchoscope (aScope III) if failure to intubate occurs

Device: King Vision video-laryngoscope with #3 disposable blade and endotracheal tube stylet; Device: fiberoptic bronchoscope aScope III

Interventional Group videolaryngoscope/fibeoptic bronch

EXPERIMENTAL

The interventional group will Intubate using the video-laryngoscope and the fiber-optic bronchoscope (aScope III)

Device: fiberoptic bronchoscope aScope III

Interventions

King Vision video-laryngoscope with #3 disposable blade and endotracheal tube stylet DEVICE

intubation using King Vision video-laryngoscope with #3 disposable blade with stylet convert to intubation with video-laryngoscope and fiber-optic bronchoscope bronchoscope (aScope III) for failure to intubate after three attempts

Also known as: Ambu aScope III

control group videolaryngoscope/preformed stylet

fiberoptic bronchoscope aScope III DEVICE

Intubation using the videolaryngoscope/fiberoptic bronchoscope (aScope III)

Also known as: aScope III by Ambu

Interventional Group videolaryngoscope/fibeoptic bronch; control group videolaryngoscope/preformed stylet

Eligibility Criteria

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

You may qualify if:

• Patient will be eligible for the trial if they:
• Have a tumor of the oral cavity, pharynx or larynx and are scheduled for biopsy or resection requiring intubation of the trachea
• Are 18 years or older
• Sign the approved inform consent

You may not qualify if:

• Patients will be excluded from the study if:
• Cannot lie down flat without suffering dyspnoea
• Stridor
• Full stomach
• Hiatal hernia
• Severe Gastroesophageal Reflux Disease (GERD) defined as already on a protein pump inhibitor and continues to have daily regurgitation
• Require rapid sequence intubation

Sponsors & Collaborators

• University of Louisville: lead
• Ambu A/S: collaborator

Study Sites (1)

University of Louisville Medical School, Department of Anesthesiology and Perioperative Medicine

Louisville, Kentucky, 40202, United States

Location

Related Publications (13)

• Juneja R, Lacey O. Anaesthesia for head and neck cancer surgery. Curr Anaesth Crit Care 2009;20:28-32.

  BACKGROUND

• Stacey M, Rassam S, Sivasankar R, Hall J. Difficulty in advancing a tracheal tube over a fibreoptic bronchoscope: more solutions. Br J Anaesth. 2005 Jul;95(1):112. doi: 10.1093/bja/aei570. No abstract available.

  PMID: 15941739 BACKGROUND

• Cooper RM. Use of a new videolaryngoscope (GlideScope) in the management of a difficult airway. Can J Anaesth. 2003 Jun-Jul;50(6):611-3. doi: 10.1007/BF03018651.

  PMID: 12826557 BACKGROUND

• Doyle DJ. GlideScope-assisted fiberoptic intubation: a new airway teaching method. Anesthesiology. 2004 Nov;101(5):1252. doi: 10.1097/00000542-200411000-00046. No abstract available.

  PMID: 15505482 BACKGROUND

• Turkstra TP, Harle CC, Armstrong KP, Armstrong PM, Cherry RA, Hoogstra J, Jones PM. The GlideScope-specific rigid stylet and standard malleable stylet are equally effective for GlideScope use. Can J Anaesth. 2007 Nov;54(11):891-6. doi: 10.1007/BF03026792.

  PMID: 17975233 BACKGROUND

• Turkstra TP, Jones PM, Ower KM, Gros ML. The Flex-It stylet is less effective than a malleable stylet for orotracheal intubation using the GlideScope. Anesth Analg. 2009 Dec;109(6):1856-9. doi: 10.1213/ANE.0b013e3181bc116a.

  PMID: 19923515 BACKGROUND

• Knill RL. Difficult laryngoscopy made easy with a "BURP". Can J Anaesth. 1993 Mar;40(3):279-82. doi: 10.1007/BF03037041.

  PMID: 8467551 BACKGROUND

• Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.

  PMID: 6507827 BACKGROUND

• Janda M, Scheeren TW, Noldge-Schomburg GF. Management of pulmonary aspiration. Best Pract Res Clin Anaesthesiol. 2006 Sep;20(3):409-27. doi: 10.1016/j.bpa.2006.02.006.

  PMID: 17080693 BACKGROUND

• Fasting S, Gisvold SE. Serious intraoperative problems--a five-year review of 83,844 anesthetics. Can J Anaesth. 2002 Jun-Jul;49(6):545-53. doi: 10.1007/BF03017379.

  PMID: 12067864 BACKGROUND

• Siu LW, Mathieson E, Naik VN, Chandra D, Joo HS. Patient- and operator-related factors associated with successful Glidescope intubations: a prospective observational study in 742 patients. Anaesth Intensive Care. 2010 Jan;38(1):70-5. doi: 10.1177/0310057X1003800113.

  PMID: 20191780 RESULT

• Van Zundert AA, Hermans B, Kuczkowski KM. Successful use of a videolaryngoscope in a patient with carcinoma of the oropharynx and obstructed airway. Minerva Anestesiol. 2009 Jul-Aug;75(7-8):475-6. No abstract available.

  PMID: 19571781 RESULT

• Lenhardt R, Burkhart MT, Brock GN, Kanchi-Kandadai S, Sharma R, Akca O. Is video laryngoscope-assisted flexible tracheoscope intubation feasible for patients with predicted difficult airway? A prospective, randomized clinical trial. Anesth Analg. 2014 Jun;118(6):1259-65. doi: 10.1213/ANE.0000000000000220.

  PMID: 24842175 RESULT

Study Officials

• Rainer Lenhardt, MD MBA

  University of Louisville 530 South Jackson Street Louisville, KY 40202

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 27, 2017
• First Posted: March 15, 2017
• Study Start: April 10, 2017
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: May 28, 2024

Record last verified: 2024-05

Locations

US (1)