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Clinical Trial

Hyperangulated Video Laryngoscopes Used for Intubation With Simultaneous Cervical Spine Immobilization

NCT: NCT07802522 · ENROLLING_BY_INVITATION

NCT IDNCT07802522
StatusENROLLING_BY_INVITATION
Start Date2026-08-31
Completion2026-10-31
SponsorUniwersytet Radomski im. Kazimierza Pułaskiego (OTHER)
First posted
Last updated

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.

Frequently Asked Questions

What is Hyperangulated Video Laryngoscopes Used for Intubation With Simultaneous Cervical Spine Immobilization?

Hyperangulated Video Laryngoscopes Used for Intubation With Simultaneous Cervical Spine Immobilization is a clinical trial registered under NCT07802522. Current status: ENROLLING_BY_INVITATION.

What is the status of NCT07802522?

The current status of NCT07802522 (Hyperangulated Video Laryngoscopes Used for Intubation With Simultaneous Cervical Spine Immobilization) is: ENROLLING_BY_INVITATION.

When did Hyperangulated Video Laryngoscopes Used for Intubation With Simultaneous Cervical Spine Immobilization start?

Hyperangulated Video Laryngoscopes Used for Intubation With Simultaneous Cervical Spine Immobilization started on 2026-08-31.

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K250243ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)Flexicare Medical Limited. K243785Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless ReinforcedCovidien, LLC K250173Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR)Covidien, LLC K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented FullFisher & Paykel Healthcare, Ltd. K173060F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow VersionFisher and Paykel Healthcare Limited

Official Source

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