Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation

NCT07614529 | Not Yet Recruiting

• 2 other identifiers: 2607A07DLT-VL 2026
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, randomized, single-center, three-arm, open-label, low-risk medical device clinical study conducted at the Department of Anesthesiology and Reanimation, Trakya University Medical Faculty. The study aims to compare the efficacy, safety, and clinical usability of three laryngoscopy methods for double-lumen endotracheal tube (DLT) intubation in patients undergoing elective thoracic surgery requiring one-lung ventilation: (i) C-MAC hyperangulated (D-blade) videolaryngoscopy, (ii) C-MAC Macintosh blade videolaryngoscopy, and (iii) direct Macintosh laryngoscopy. The primary outcome is the total time to successful DLT placement (in seconds), defined as the interval from the end of mask ventilation to fiberoptic bronchoscopic confirmation of correct tube position. Secondary outcomes include glottic visualization quality (POGO score and Cormack-Lehane grade), intubation difficulty (Intubation Difficulty Scale), number of intubation attempts, need for auxiliary maneuvers, intubation-related complications, malposition rate, and postoperative airway symptoms (sore throat, dysphonia) assessed at 1, 6, and 24 hours postoperatively. Eligible patients are adults (≥18 years), ASA class I-III, scheduled for elective thoracic surgery requiring one-lung ventilation. Patients with anticipated difficult airway, emergency surgery, pregnancy, or prior upper airway surgery are excluded. A total of 180 patients will be enrolled and randomized 1:1:1 into three groups (60 per group) using computer-generated block randomization.

Conditions

Endobronchial Intubation; Thoracic Surgery; Double Lumen Tube Intubation; One Lung Ventillation (OLV)

Keywords

double-lumen endotracheal tube; videolaryngoscopy; direct laryngoscopy; C-MAC; thoracic anesthesia; one-lung ventilation

Outcome Measures

Primary Outcomes (1)

• Total time to successful double-lumen endotracheal tube placement-seconds

  Total intubation time in seconds, defined as the interval from cessation of mask ventilation to the appearance of the first complete end-tidal CO2 waveform confirming successful endotracheal tube placement. Final tube position is verified by fiberoptic bronchoscopy. If the tube is not placed properly, fiberoptic bronchoscopy is used to correct the position. Time is recorded continuously for each participant using a stopwatch. In cases requiring multiple intubation attempts, cumulative time across all attempts is recorded. Cases requiring activation of the difficult airway algorithm after three failed attempts are classified as intubation failure and analyzed separately.

  Intraoperative (from cessation of mask ventilation to appearance of the first complete end-tidal CO2 waveform confirming successful DLT placement, assessed immediately after intubation)

Secondary Outcomes (10)

• Glottic visualization quality - POGO score

  Intraoperative (assessed immediately upon laryngoscope insertion)

• Glottic visualization quality - Cormack-Lehane grade

  Intraoperative (assessed immediately upon laryngoscope insertion)

• Intubation difficulty - Intubation Difficulty Scale (IDS)

  Intraoperative (assessed immediately after intubation)

• Number of intubation attempts

  Intraoperative (recorded during the intubation procedure)

• Rate of need for auxiliary maneuvers

  Intraoperative (recorded during the intubation procedure)

Study Arms (3)

Hyper-angulated blade C-MAC videolaryngoscopy

EXPERIMENTAL

HCMAC: DLT intubation performed using the Storz C-MAC hyperangulated D-blade videolaryngoscope. The D-blade provides an acutely angled geometry and transmits a high-resolution glottic image to an external monitor. The DLT stylet is shaped to match the hyperangulated blade curvature prior to intubation. Glottic view, intubation time, number of attempts, auxiliary maneuvers, and intubation-related complications are recorded. Correct tube placement is confirmed by fiberoptic bronchoscopy.

Device: C-MAC Hyperangulated D-Blade Videolaryngoscopy

Macintosh-type blade C-MAC videolaryngoscopy

EXPERIMENTAL

MCMAC: DLT intubation performed using the Storz C-MAC Macintosh blade videolaryngoscope. The Macintosh geometry blade allows both direct and indirect (video-assisted) laryngoscopy and preserves standard hand mechanics familiar to the operator. The DLT stylet is shaped to match the Macintosh blade curvature prior to intubation. Glottic view, intubation time, number of attempts, auxiliary maneuvers, and intubation-related complications are recorded. Correct tube placement is confirmed by fiberoptic bronchoscopy.

Device: C-MAC Macintosh Blade Videolaryngoscopy

Direct laryngoscopy

ACTIVE COMPARATOR

DL: DLT intubation performed using a standard direct Macintosh laryngoscope without video assistance. This arm serves as the active comparator representing current standard clinical practice for DLT intubation in thoracic surgery. The DLT stylet is shaped to match the Macintosh blade curvature prior to intubation. Glottic view, intubation time, number of attempts, auxiliary maneuvers, and intubation-related complications are recorded. Correct tube placement is confirmed by fiberoptic bronchoscopy.

Device: Direct Macintosh Laryngoscopy

Interventions

C-MAC Hyperangulated D-Blade Videolaryngoscopy DEVICE

Double-lumen endotracheal tube intubation performed using the Storz C-MAC hyperangulated D-blade videolaryngoscope. The D-blade provides an acutely angled viewing geometry with high-resolution video transmission to an external monitor. The DLT stylet is shaped to match the D-blade curvature prior to intubation. All devices are CE-marked and used in accordance with the manufacturer's intended purpose.

Hyper-angulated blade C-MAC videolaryngoscopy

C-MAC Macintosh Blade Videolaryngoscopy DEVICE

Double-lumen endotracheal tube intubation performed using the Storz C-MAC Macintosh blade videolaryngoscope. The Macintosh geometry blade enables both direct and video-assisted laryngoscopy while preserving standard hand mechanics. The DLT stylet is shaped to match the Macintosh blade curvature prior to intubation. All devices are CE-marked and used in accordance with the manufacturer's intended purpose.

Macintosh-type blade C-MAC videolaryngoscopy

Direct Macintosh Laryngoscopy DEVICE

Double-lumen endotracheal tube intubation performed using a standard direct Macintosh laryngoscope without video assistance. This represents current standard clinical practice for DLT intubation in thoracic surgery and serves as the active comparator. The DLT stylet is shaped to match the Macintosh blade curvature prior to intubation. All devices are CE-marked and used in accordance with the manufacturer's intended purpose.

Direct laryngoscopy

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older
• Written informed consent obtained prior to surgery
• ASA physical status class I, II, or III
• Scheduled for elective thoracic surgery requiring one-lung ventilation and double-lumen endobronchial intubation

You may not qualify if:

• Age under 18 years
• Refusal or inability to provide informed consent
• ASA physical status class IV or above
• Emergency surgery
• Anticipated difficult airway, defined by any of the following: Mallampati score 4, thyromental distance less than 6.5 cm, restricted mouth opening, or BMI greater than 30 kg/m²
• History of upper airway surgery
• Significant upper airway obstruction or stridor
• Pregnancy

Sponsors & Collaborators

• Trakya University: lead

Related Links

• Related Info
• Related Info

Central Study Contacts

havva suheyla akin uzan, medical doctor

CONTACT

+905079516118; shylaakin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 29, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): November 15, 2028
• Study Completion (Estimated): January 15, 2029
• Last Updated: May 29, 2026

Record last verified: 2026-05