VivaSight-SL Versus Videolaryngoscopy in Expected Difficult Airway (VivaOP)

Endotracheal Tube-mounted Camera Assisted Intubation Versus Videolaryngoscopic Intubation in Patients With Expected Difficult Airway - a Prospective Randomized Trial

Patients requiring endotracheal intubation for elective surgery with an expected difficult airway are randomized to be intubated either by a) videolaryngoscopy or b) an endotracheal tube-mounted camera.

Study Overview

• Status: Completed
• Conditions: Airway Management
• Intervention / Treatment: Procedure: VivaSight; Procedure: Videolaryngoscopy

Detailed Description

Endotracheal intubation is required for different surgical procedures for mechanical ventilation and to prevent aspiration of secretions. Endotracheal intubation is usually performed by direct laryngoscopy (DL), but this technique may fail in patients with a difficult airway, i.e. during otorhinolaryngologic or oral and maxillofacial surgery. Besides fiberoptic intubation that is regarded as gold standard, videolaryngoscopy (VL) has evolved as a valuable alternative technique in patients with a difficult airway. However, VL has its limitations and may also fail due to insufficient visualization of the larynx. An endotracheal tube with an integrated camera (VST, VivaSight-SL, Ambu A/S, Ballerup, Denmark) may allow for direct guidance of the tube and may aid in endotracheal intubation in difficult airway patients. This tube has been evaluated in intensive care patients and in patients with morbid adiposity compared to DL, but there is a paucity of data in difficult airway patients, so far.

Therefore, we aim to test the VST in difficult airway patients compared to VL in a prospective randomized non-inferiority trial.

Patients will be assessed for eligibility in the Anesthesiology Pre-assessment Clinic of the University Medical Center Hamburg-Eppendorf prior to elective surgery.

All patients receive a structured preoperative airway assessment in accordance with standard operating procedure of the Department of Anesthesiology, University Medical Center Hamburg-Eppendorf using the implemented in-house algorithm for the prediction of difficult airway management and the Simplified Airway Risk Index (SARI).

Patients randomized to the intervention group will be intubated with a VST. Depending on gender and patient's size, tubes with inner diameters of 7.0, 7.5, and 8.0 are available. The tubes camera is connected to an Ambu aView monitor (Ambu A/S, Ballerup, Denmark). Patients randomized to the control group are intubated with a C-MAC videolaryngoscope (Karl Storz SE & Co. KG, Tuttlingen, Germany) with a Macintosh type blade size 3 or 4 blade.

Anesthesia management, the choice of the blade and tube size, as well as the use of adjuncts like stylets, introducers or forceps or airway optimization maneuvers (e.g. backward upward rightward pressure [BURP] and optimum external laryngeal manipulation [OELM]) will be left to the discretion of the attending physician.

All intubations are recorded through the monitors for later review (e.g. Cormack-Lehane and POGO-score).

Based on an expected endtidal fraction of oxygen after intubation of 80% with a standard deviation of 8%, and a noninferiority margin of 10%, 2x 24 patients are required with errors of α=0.025 and β=0.2 (PASS version 08.0.6, NCSS, LLC. Kaysville, UT, USA).

All participating physicians are anesthesiology residents or fellows. To avoid a bias that may occur due to different skills for VL compared to the VST, physicians participating in this study take part in a structured manikin airway training. The age and months of work experience of the participating anesthetists will be assessed within a questionnaire. It has been shown that novice physicians are able to reliably intubate a manikin with the VST after a 30 min training session of DL and VST. For VL, it has been shown that novice physicians may intubate manikins set up to a difficult airway scenario after a brief introduction and five intubations with the VL and that anesthesiology residents may quickly adopt the use of the C-MAC VL.

Therefore, participating physicians are trained for 30 min under the supervision of an independent anesthetist before participating in this study.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • HH
    • Hamburg, HH, Germany, 20246
      • Universitätsklinikum Hamburg-Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients requiring general anesthesia with transoral tracheal intubation for elective surgery
• Age ≥ 18
• Preoperative airway assessment reveals an expected difficult airway (rated by the responsible anesthetist in the Pre-assessment Clinic based on the existing in-house algorithm)

Exclusion Criteria:

• Pregnant or breastfeeding woman
• Confirmed indications for awake fiberoptic intubation especially due to enoral, pharyngeal tumors, abscesses or other processes
• Planned endotracheal intubation without deep anesthesia or neuromuscular blocking agents (e.g. awake videolaryngoscopy)
• Required transnasal tracheal intubation (e.g. for surgical reasons)
• Requirement of special endotracheal tubes such as laser or RAE tubes for surgical reasons
• Patients at risk for pulmonary aspiration who qualify for rapid sequence induction
• Loose teeth
• Denial of consent

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VivaSight; Intubated with a VivaSight-SL endotracheal tube.	Procedure: VivaSight; see above
Active Comparator: Conventional; Intubated by videolaryngoscopy.	Procedure: Videolaryngoscopy; see above; Other Names: comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
first-pass success	percentage of successful intubations with one attempt	15 minutes
end-tidal oxygen fraction	the lowest end-tidal oxygen fraction within two minutes after successful intubation after a standardized preoxygenation	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall success rate	percentage of successful intubations with the allocated procedure	15 minutes
time to successful intubation	time until an endotracheal airway access is established	15 minutes
time to successful intubation with one attempt	time until an endotracheal airway access is established in patients that are intubated at first attempt	15 minutes
intubation difficulty	subjective rating on a visual analogue scale of the difficulty of airway management and questionnaire	15 minutes
end-tidal carbondioxide fraction	the highest end-tidal carbondioxide fraction within two minutes after successful intubation	15 minutes
number of attempts	total number of attempts until airway established	15 minutes
aspiration	percentage of patients that vomit and aspirate during intubation	15 minutes
esophageal intubation	percentage of accidental esophageal intubation attempts	15 minutes
hypoxia	percentage of patients with a desaturation below a pulsoximetric saturation of 80%	15 minutes
hypotension	percentage of patients with a systolic blood pressure below 70 mmHg	15 minutes
intubating conditions	grades according to Cormack-Lehane and POGO	15 minutes

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2020
• Primary Completion (Actual): February 12, 2021
• Study Completion (Actual): February 12, 2021

Study Registration Dates

• First Submitted: August 2, 2020
• First Submitted That Met QC Criteria: August 2, 2020
• First Posted (Actual): August 6, 2020

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 7, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: VivaOP

Drug and device information, study documents

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