Video-Laryngoscope Alone or With Bronchoscope for Predicted Difficult Intubation (COMBO)

Comparison of Video-Laryngoscope Versus a Combination of a Video-Laryngoscope and Disposable Bronchoscope for Predicted Difficult Airway Intubation of Anesthetized Patients for Oral Cavity, Pharynx or Larynx Surgery

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

Study Overview

• Status: Recruiting
• Conditions: Intubation; Difficult
• Intervention / Treatment: Device: King Vision video-laryngoscope with #3 disposable blade and endotracheal tube stylet; Device: fiberoptic bronchoscope aScope III

Detailed Description

Detailed Description:

All subjects consented to this study will require endotracheal intubation. They will be randomly assigned to either one of two groups. The randomization will be stratified on whether the subject has an oral cavity/pharynx tumor or laryngeal tumor. The randomization groups are:

1. Intubation using King Vision video-laryngoscope with the disposable #3 blade and a stylet for placement of the endotracheal tube. This group is considered the "control group".
2. Intubation using the King Vision video-laryngoscope with the disposable #3 blade and the fiber-optic bronchoscope (aScope III). This group is considered the "interventional group".

When randomized to the "control group" (King Vision video-laryngoscope with #3 disposable blade and a stylet) the procedure sequence is as follows:

1. Standard anesthesia monitoring which includes but is not limited to ECG, pulse oximetry, capnography, blood pressure and temperature monitoring. Their head will be on an anesthesia pillow. This is all standard procedure.
2. Anesthesiologist will induced with Fentanyl (1-2 ug/kg), propofol (2-4 mg/kg). This is standard dosing.
3. Subjects will receive muscle relaxation using Rocuronium (0.6mg/kg) This is standard dosing.
4. The patient will be pre-oxygenated for 2-3 minutes with 100% oxygen by mask to achieve optimal oxygen saturation
5. One anesthesiologist will perform the intubation procedure using the King Vision video-laryngoscope with a #3 disposable blade and use a stylet to pre-form the endotracheal tube (ETT).
6. If the anesthesiologist's first attempt to intubate should fail the next attempt will use the standard Storz video-laryngoscope and a #4 reusable blade, a stylet to pre-form the endotracheal tube (ETT) and with external laryngeal pressure. (BURP: back, up, and rightward pressure)
7. The anesthesiologist may make a total of three attempts to intubate using the control group procedures. Each attempt should be less than 60 seconds and will be aborted if oxygen saturation falls below 90%. The patient will be pre-oxygenated by mask between each attempt.
8. After three failed attempts to intubate the anesthesiologist will use the interventional group method. Two anesthesiologists will be required to perform the intubation using the King Vision video-laryngoscope with a #3 disposable blade and the video bronchoscope (aScope III). The stylet will not be needed since the bronchoscope will be used to guide the endotracheal tube (ETT).
9. The video-laryngoscope will be used to visualize the glottis; the bronchoscope (aScope III) will be inserted underneath the epiglottis and advance to the carina under direct visualization. The endotracheal tube (ETT) will be threaded over the bronchoscope (aScope III) using the bronchoscope as a guide through the trachea.
10. Should the first attempt using the interventional method fail the next attempt will use the standard Storz video-laryngoscope and #4 reusable blade along with the video bronchoscope (aScope III)
11. There may be three attempts using the interventional method. Each attempt should be less than 60 seconds. If the oxygen saturation decreases below 90% the attempt should be aborted. The patient will be pre-oxygenated by mask between each attempt.
12. After three unsuccessful attempts the patient will be awaken and an "awake" intubation procedure will take place.
13. The anesthesiologist will note any bleeding occurring during the procedure. Bleeding will be assessed as minimal, moderate, and significant.
14. Study ends once the patient is intubated and breath sounds confirmed or when it is decided an "awake" intubation is needed.

When randomized to the "interventional" group. (King Vision video-laryngoscope and #3 disposable blade and the video-bronchoscope (aScope III) The sequence of procedures will be:

1. Standard anesthesia monitoring which includes but is not limited to ECG, pulse oximetry, capnography, blood pressure and temperature monitoring. Their head will be on an anesthesia pillow. This is all standard procedure.
2. Anesthesiologist will induced with Fentanyl (1-2 ug/kg), propofol (2-4 mg/kg). This is standard dosing.
3. Subjects will receive muscle relaxation using Rocuronium (0.6mg/kg)This is standard dosing.
4. The patient will be pre-oxygenated for 2-3 minutes with 100% oxygen by mask to achieve optimal oxygen saturation
5. Two anesthesiologist will perform the procedure
6. The video-laryngoscope will be used to visualize the glottis; the bronchoscope (aScope III) will be inserted underneath the epiglottis and advance to the carina under direct visualization. The endotracheal tube (ETT) will be threaded over the bronchoscope (aScope III) using the bronchoscope as a guide through the trachea.
7. Should the first attempt fail to intubate the patient the next attempt will use the Storz video- laryngoscope with a #4 reusable blade with the video-bronchoscope (aScope III)
8. A total of three attempts may be made using the interventional method. Each attempt should be less than 60 seconds and aborted if the oxygen saturation falls below 90%. The patient will be pre-oxygenated by mask with 100% oxygen between each attempt.
9. If failure to intubate should occur the patient will be awaken and an "awake" intubation will be performed.
10. The anesthesiologist will note any bleeding occurring during the procedure. Bleeding will be assessed as minimal, moderate, and significant.
11. The study will end with successful intubation and confirmation of breath sounds or when it is determined an "awake" intubation is necessary.

• Study Type: Interventional
• Enrollment (Estimated): 85
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rainer Lenhardt, MD, MBA; Phone Number: 502852-3122; Email: rainer.lenhardt@louisville.edu
• Study Contact Backup: Name: Elizabeth A Cooke, RN BSN CCRP; Phone Number: 502-852-8016; Email: eacooke02@louisville.edu

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • University of Louisville Medical School, Department of Anesthesiology and Perioperative Medicine
      • Contact: Reiner Lenhardt, MD MBA; Phone Number: 502-852-3122; Email: reiner.lenhardt@louisville.edu
      • Contact: Elizabeth Cooke, RN BSN CCRP; Phone Number: 502-852-8016; Email: eacook02@louisville.edu

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patient will be eligible for the trial if they:

  1. Have a tumor of the oral cavity, pharynx or larynx and are scheduled for biopsy or resection requiring intubation of the trachea
  2. Are 18 years or older
  3. Sign the approved inform consent

Exclusion Criteria:

• Patients will be excluded from the study if:

  1. Cannot lie down flat without suffering dyspnoea
  2. Stridor
  3. Full stomach
  4. Hiatal hernia
  5. Severe Gastroesophageal Reflux Disease (GERD) defined as already on a protein pump inhibitor and continues to have daily regurgitation
  6. Require rapid sequence intubation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group videolaryngoscope/preformed stylet; 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; 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; Other Names: Ambu aScope III; Device: fiberoptic bronchoscope aScope III; Intubation using the videolaryngoscope/fiberoptic bronchoscope (aScope III); Other Names: aScope III by Ambu
Experimental: Interventional Group videolaryngoscope/fibeoptic bronch; The interventional group will Intubate using the video-laryngoscope and the fiber-optic bronchoscope (aScope III)	Device: fiberoptic bronchoscope aScope III; Intubation using the videolaryngoscope/fiberoptic bronchoscope (aScope III); Other Names: aScope III by Ambu

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conversion from control group to intervention group	Number of subjects randomized to control group who require to be treated with the method of the 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	whole numbers of attempts	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

Collaborators and Investigators

• Sponsor: University of Louisville
• Collaborators: Ambu A/S
• Investigators: Principal Investigator: Rainer Lenhardt, MD MBA, University of Louisville 530 South Jackson Street Louisville, KY 40202

Publications and helpful links

General Publications

• Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.
• Juneja R, Lacey O. Anaesthesia for head and neck cancer surgery. Curr Anaesth Crit Care 2009;20:28-32.
• 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.
• 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.
• 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.
• 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.
• 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.
• Knill RL. Difficult laryngoscopy made easy with a "BURP". Can J Anaesth. 1993 Mar;40(3):279-82. doi: 10.1007/BF03037041.
• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: Anesth Analg. 2015 Feb;120(2):495.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2017
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: January 27, 2017
• First Submitted That Met QC Criteria: March 9, 2017
• First Posted (Actual): March 15, 2017

Study Record Updates

• Last Update Posted (Actual): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IRB #15.0096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: individual patients data will not be shared. Results or the studies findings will be published

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes