Hyperangulated Video Laryngoscopes Used for Intubation With Simultaneous Cervical Spine Immobilization

NCT07802522 | Enrolling By Invitation

• 1 other identifier: 2/2026
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate four videolaryngoscopes used for intubation of patients with cervical spine immobilization. Two hundred adult patients (females and males) with ASA (American Society of Anesthesiologist) status 1-3 will be scheduled for elective laparoscopic surgery at the Mazowiecki Szpital Specjalistyczny in Radom, Poland. Patients with known difficult laryngoscopy, difficult face mask ventilation, with previous history of awake tracheal intubation, those aged under 18 years or patients with BMI \> 30 kg m-2 will be excluded from the study. All patients will receive oral premedication with 7.5 mg midazolam 30 minutes before the start of anaesthesia. A standard monitoring will be applied. This consists of ECG, NIBP (non-invasive blood pressure), SpO2, TOF (train-of-four) and volatile anaesthetic concentration. In order to achieve cervical spine immobilization, a Patriot® cervical collar (Össur hf., Reykjavik, Iceland) will be applied. The size of the collar will be adjusted to the patient's anatomy. Furthermore, the cervical collar will be fixed to allow a minimal mouth opening of 20 mm. All patients will be placed in a neutral position and will be pre-oxygenated with FiO2 1.0 for three minutes prior to induction. Anaesthesia will be induced with fentanyl (1-2 µg ml-1) and propofol (2-3 mg ml-1). Rocuronium (0.6 mg ml-1) will be used as a neuromuscular blocking agent. Adequate neuromuscular block will be confirmed and controlled throughout the procedure with TOF Watch (Organon, Dublin, Ireland). A cuffed, size 7.5 tracheal tube with stylet (Sumi, Sulejówek, Poland) will be used for intubation. A single-use hyperangulated blade will be used in all studied devices. Correct placement of the tracheal tube will be confirmed by videolaryngoscopy, capnography and chest auscultation. All patients will be anaesthetised by experienced consultant anaesthetists with over 10 years of clinical practice after completion of specialist training. Furthermore, all anaesthetists participating in the study will be trained beforehand with all VLs used until they feel competent. Only two intubation attempts with a studied videolaryngoscope will be allowed. A single attempt will be limited to 60 seconds. A failure is defined as an attempt which lasts more than 60 seconds, when saturation drops below 90%, after two unsuccessful attempts, when airway injury or bronchospasm occurrs. A single-digit number will be allocated to each of the studied videolaryngoscopes: 1 for the C-MAC PM, 2 for the McGrath, 3 for the VisionPro and 4 for the AceScope. A single sheet of paper containing printed number will be placed in an opaque envelope. Then they will be assigned to the participating anaesthetist by computer-generated randomization. The SPSS 29.0 software (IBM, Armonk, NY, USA) will be used for allocation. Furthermore, patients will be blinded to randomization.

Conditions

Cervical Spine Immobilisation; Airway Management; Difficult Airway

Keywords

videolaryngoscope; difficult airway; hyperangulated blade; cervical spine immobilisation; intubation

Outcome Measures

Primary Outcomes (2)

• First-attempt success

  This is the percentage of successful tracheal tube placement at the first attempt.

  From date of randomization until the date of first documented progression, assessed up to 10 months

• Intubation time

  The intubation time is defined as the time from picking up the videolaryngoscope until the correct placement of the tracheal tube has been confirmed by capnography. A stop watch of a mobile phone (Apple, Cupertino, CA, USA) will be used to measure the intubation time.

  From date of randomization until the date of first documented progression, assessed up to 10 months

Secondary Outcomes (2)

• User-friendliness of the device used

  From date of randomization until the date of first documented progression, assessed up to 10 months

• The time required to achieve the glottic view

  From date of randomization until the date of first documented progression, assessed up to 10 months

Study Arms (4)

VisionPro

EXPERIMENTAL

Device used for intubation

Device: Airway management

C-MAC

ACTIVE COMPARATOR

Device used for intubation

Device: Airway management

McGrath

ACTIVE COMPARATOR

Device used for intubation

Device: Airway management

AceScope

ACTIVE COMPARATOR

Device used for intubation

Device: Airway management

Interventions

Airway management DEVICE

Device used for intubation

AceScope; C-MAC; McGrath; VisionPro

Eligibility Criteria

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

You may qualify if:

• ASA status 1-3
• aged over 18 years old
• male and female
• laparoscopic surgery

You may not qualify if:

• known difficult laryngoscopy
• difficult face mask ventilation
• aged under 18 years old
• previous history of awake tracheal intubation
• patients with BMI \> 30 kg m-2

Sponsors & Collaborators

• Uniwersytet Radomski im. Kazimierza Pułaskiego: lead

Study Sites (1)

Uniwersytet Radomski

Radom, Masovian Voivodeship, 26-600, Poland

Location

MeSH Terms

Interventions

Airway Management

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 3, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: September 3, 2026

Record last verified: 2026-08

Locations

PL (1)