Clinical trial

Videolaryngoscopes in the Morbidly Obese

Invitation only · Not applicable · 1 countries · Registry ID NCT07787468

Invitation onlyNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionObesity Difficult Airway Airway Management

Full registry criteria

Inclusion Criteria: * class 3 obesity * bariatric surgery * over 18 years old * male and female Exclusion Criteria: * known difficult laryngoscopy * difficult face mask ventilation * aged under 18 years old * previous history of awake tracheal intubation

Treatments and study arms

Airway management

Device

Device used for intubation

Primary outcomes

First-attempt successFrom date of randomization until the date of first documented progression, assessed up to 10 months

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

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

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Uniwersytet Radomski🇵🇱 Radom, Masovian Voivodeship, Poland

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