Clinical Comparison Between Midline and Right-sided Insertion of the Videolaryngoscope for Endotracheal Intubation

NCT05635500 | Completed DMC

• 1 other identifier: EA2/121/21
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 2

Brief Summary

The videolaryngoscope is an established tool for securing the airway, even in difficult situations. It remains unclear which insertion technique is the safest and fastest in the difficult airway.

Conditions

Intubation; Difficult or Failed

Outcome Measures

Primary Outcomes (1)

• Comack-Lehane Classification

  Laryngeal vision is determined by Cormack/Lehane classification (C/L)

  immediately after the intervention

Secondary Outcomes (5)

• Time to intubate

  immediately after the intervention

• First pass success

  immediately after the intervention

• Time to laryngeal view

  immediately after the intervention

• Complications during induction

  15 minutes

• Complication on first postoperative day

  24 hours

Study Arms (2)

Middle Insertion

EXPERIMENTAL

Videolaryngoscope is inserted from the middle for endotracheal intubation.

Procedure: Different Approach to endotracheal intubation.

Right Insertion

NO INTERVENTION

Videolaryngoscope is inserted from the right for endotracheal intubation.

Interventions

Different Approach to endotracheal intubation. PROCEDURE

Different insertion way.

Middle Insertion

Eligibility Criteria

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

You may qualify if:

• Elective surgery under general anesthesia with indication for airway protection via endotracheal intubation
• age ≥ 18 years
• indication for primary videolaryngoscopic Intubation (VLS) and/or at least one of the following criteria:
• Mallampati ≥ 3
• Thyromental distance \<6.5cm
• Sternalomental distance \<12.5 cm
• Conversion from conventional laryngoscopy to VLS in history
• Cervical spine immobilization/lack of ability to recline.

You may not qualify if:

• Pregnant patients
• Participation in another prospective clinical intervention study within the last 30 days and during participation in this study
• Necessary Rapid Sequence Induction
• Indications of impossible mask ventilation and/or videolaryngoscopy (mouth opening \< 3.5 cm, ...)
• Existence of tracheal cannula prior to operation

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (2)

Department of Anesthesia and operative intensive Care, Campus Benjamin Franklin, Charité - University Hospital Berlin

Steglitz, State of Berlin, 12203, Germany

Location

Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin

Berlin, 12203, Germany

Location

Related Publications (1)

• Jiang L, Qiu S, Zhang P, Yao W, Chang Y, Dai Z. The midline approach for endotracheal intubation using GlideScope video laryngoscopy could provide better glottis exposure in adults: a randomized controlled trial. BMC Anesthesiol. 2019 Nov 5;19(1):200. doi: 10.1186/s12871-019-0876-6.

  PMID: 31690285 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Computer generated randomisation, Patient under general anaesthesia during procedure
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Model Details: Computer generates randomisation in two groups middle insertion (n=92) and right insertion (n=92)

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: December 2, 2022
• Study Start: August 1, 2021
• Primary Completion: May 25, 2023
• Study Completion: May 26, 2023
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)