Badanie kliniczne: Cervical Spine Immobilisation

Gdzie prowadzone jest badanie

Ośrodki prowadzące badanie w Polsce (1), alfabetycznie według miejscowości:

• Uniwersytet Radomski Rekrutuje
  RadomKontakt

Więcej badań w tych miastach:

• Radom

Stan rekrutacji pochodzi z rejestrów badań i może się zmienić szybciej, niż zaktualizuje go sponsor. Nasz doradca sprawdzi aktualny stan w wybranym ośrodku. Nie publikujemy nazwisk lekarzy ani ich danych kontaktowych.

Cel badania

Opis z rejestru (w języku angielskim):

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.

Leczenie w badaniu

Kryteria udziału

Kryteria w języku angielskim, tak jak w rejestrze.

To główne kryteria z rejestru. Pełną listę i ostateczną decyzję o udziale ustala lekarz prowadzący badanie.