Videolaryngoscopes in the Morbidly Obese

NCT07787468 | Enrolling By Invitation

• 1 other identifier: 1/2026
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate four videolaryngoscopes used for intubation of extremely obese (class 3 obesity) patients scheduled for bariatric surgery. One hundred adult patients will be scheduled for an elective sleeve gastrectomy at the Mazowiecki Szpital Specjalistyczny in Radom, Poland. All patients will receive premedication with 300 mg pregabalin 30 minutes before the start of anaesthesia. An extended monitoring will be applied. This consists of ECG, IBP (invasive blood pressure), SpO2, TOF (train-of-four), entropy and volatile anaesthetic concentration. All patients will be placed in a ramped position (HELP - Head-elevated Laryngoscopy Position) and will be pre-oxygenated with FiO2 1.0 for three minutes prior to induction. A standardised local protocol of opioid-free anaesthesia for bariatric patients will be utilised. Prior to proper induction of anaesthesia, IV infusions of 1% lidocaine and dexmedetomidine 10 µg ml-1 will be started. This will be followed by induction with IV propofol (200 mg) and ketamine (50 mg). Rocuronium (100 mg) 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 8.0 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 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 lasted more than 60 seconds, when saturation dropped below 90%, after two unsuccessful attempts, when airway injury or bronchospasm occurred. A single-digit number will be allocated to each of the studied videolaryngoscopes: 1 for the C-MAC PM, 2 for the McGrath MAC, 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

Obesity Difficult Airway Airway Management

Keywords

Videolaryngoscope; Class 3 obesity; Difficult airway; 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)

• Image quality

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

• User-friendliness of the device used

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

Study Arms (4)

C-MAC PM

EXPERIMENTAL

Device: Airway management

McGrath MAC

EXPERIMENTAL

Device: Airway management

VisionPro

ACTIVE COMPARATOR

Device: Airway management

AceScope

ACTIVE COMPARATOR

Device: Airway management

Interventions

Airway management DEVICE

Device used for intubation

AceScope; C-MAC PM; McGrath MAC; VisionPro

Eligibility Criteria

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

You may qualify if:

• class 3 obesity
• bariatric surgery
• over 18 years old
• male and female

You may not qualify if:

• known difficult laryngoscopy
• difficult face mask ventilation
• aged under 18 years old
• previous history of awake tracheal intubation

Sponsors & Collaborators

• Uniwersytet Radomski im. Kazimierza Pułaskiego: lead

Study Sites (1)

Uniwersytet Radomski

Radom, Masovian Voivodeship, 26-600, Poland

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Airway Management

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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 18, 2026
• First Posted: August 26, 2026
• Study Start: August 15, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 26, 2026

Record last verified: 2026-08

Locations

PL (1)