Videolaryngoscopic Intubation Using Macintosh vs.Hyperangulated Blades in Patients With Expected Difficult Intubation

NCT ID: NCT05522049

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-17
• Study Completion Date: 2023-07-31

Brief Summary

Videolaryngoscopy-guided intubation has become widespread as a means of preventing major complications relating to airway management by improving the glottic view, increasing the first attempt success rate, likely reduce rates of hypoxemic events, while reducing the rate of airway trauma. However, as randomized controlled studies in patients with anticipated difficult intubation undergoing ear nose and throat (ENT) or oral and maxillofacial (OMF) surgery are lacking, it is still unknown if hyperangulated blades improve glottic view and if their use translates into faster intubation. The primary aim of this randomized controlled trial is to compare the percentage of glottic opening (POGO) between hyperangulated blades and Macintosh blades in patients with expected difficult intubation undergoing ENT or OMF surgery who require transoral tracheal intubation. Secondary aims are to compare secondary outcome measures such as time variables, indicators for difficult and successful intubation, number of attempts, view conditions, difficult airway classifications and adverse events between both blade types.

Conditions

Intubation; Difficult or Failed; Videolaryngoscopy; General Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Intervention group

Tracheal intubation facilitated by a hyperangulated videolaryngoscope (C-MAC D-Blade)

Group Type: EXPERIMENTAL

hyperangulated videolaryngoscope

Intervention Type: DEVICE

Intubation using a hyperangulated videolaryngoscope

Control group

Tracheal intubation facilitated by a videolaryngoscope with a Macintosh type blade (C-MAC)

Group Type: ACTIVE_COMPARATOR

Macintosh videolaryngoscope

Intervention Type: DEVICE

Intubation using a Macintosh videolaryngoscope

Interventions

hyperangulated videolaryngoscope

Intubation using a hyperangulated videolaryngoscope

Intervention Type: DEVICE

Macintosh videolaryngoscope

Intubation using a Macintosh videolaryngoscope

Intervention Type: DEVICE

Other Intervention Names

C-MAC D-Blade; Storz; C-MAC; Storz

Eligibility Criteria

Inclusion Criteria

• Patients requiring general anesthesia with transoral tracheal intubation for elective ear, nose and throat or maxillofacial surgery
• Expected difficult intubation
• Age ≥ 18

Exclusion Criteria

• Pregnant or breastfeeding woman
• Planned awake tracheal intubation (without deep anesthesia or neuromuscular blocking agents)
• Required transnasal tracheal intubation (e.g. for surgical reasons)
• Special tubes required for surgical reasons ( e.g. double lumen tube)
• Denial of consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Petzoldt, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Countries

Germany

Other Identifiers

2022-100868-BO-ff

Identifier Type: -

Identifier Source: org_study_id