Clinical trial NCT05494463: Miller Blade for Intubation in Adults
Official title: Comparison of the Miller Laryngoscope and the Macintosh Laryngoscope During Endotracheal Intubation in Adult Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intubation Complication
Keywords: laryngoscopy
endotracheal intubation
Miller blade
Macintosh blade
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2022-08-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: First laryngoscopy with randomly choosed blade and then laryngoscopy wiht second choosen blade in the same patient
Primary purpose: DIAGNOSTIC

Brief summary: The study compares laryngeal view obtained with standard Macintosh blade laryngoscope and Miller blade laryngoscope in adult patients. After introduction to general anesthesia anesthesiologist will perform laryngoscopy with one chosen blade and after evaluation of visualisation of entrance to larynx will change blade to second one and repeat evaluation.

Detailed description: Tracheal intubation is the gold standard of the airway in the operating theater in patients undergoing general anesthesia for surgery, in intensive care and emergency medicine, in patients with severe respiratory failure, which is life-threatening. The laryngoscope is a device used to visualize the entrance to the airway and the subsequent insertion of the tracheal tube into the trachea and main bronchus. Macintosh and Miller laryngoscopes have been used in clinical practice for several decades. The Macintosh laryngoscope is most commonly used for the intubation of adult patients, and the Miller laryngoscope for the intubation of newborns, including premature babies and pediatric patients. Currently, when we are dealing with the sars covid-19 virus epidemic and a large number of patients with respiratory failure requiring endotracheal intubation and replacement ventilation, searching for a device that facilitates endotracheal intubation, especially by people with little experience in using it, in the absence of anesthesiologists, seems to be justified. The aim of the study will be to assess the possibility of using the Miller's laryngoscope for intubation of adult patients and to compare it with the most frequently used Macintosh laryngoscope in this group of patients. The study will include patients scheduled for elective surgery under general endotracheal anesthesia. After a typical induction of anesthesia with the use of short-term intravenous anesthetics, opioids and muscle relaxants, appropriate for the planned surgery and a specific patient, after obtaining complete neuromuscular blockade, a Macintosh laryngoscope will be inserted to perform direct laryngoscopy and assess the exit to the respiratory tract with the help of the Cormack scale. Then the laryngoscope will be removed, the patient will receive active oxygen therapy to increase blood oxygenation to the value of 99-100%, and then an additional dose of intravenous anesthetic will be administered and a second direct laryngoscopy will be performed with the Miller's laryngoscope with a subsequent assessment of airway entry using the scale Cormack. The patient will then be intubated and connected to an anesthesia machine.

Eligibility criteria: Inclusion Criteria:

* all patients scheduled for elective procedures under general anesthesia with endotracheal intubation

Exclusion Criteria:

* patients with expected difficutl intubation requiring advanced intubation techniques
* with injuries of the cervical spine, or for surgery in the cervical spine
* patients with increased intracranial and intraocular pressure, with vascular changes in the CNS and other parts of the body
* patients with ASA III and above
* patients who do not consent to participate in the study

Primary outcomes:
measure: Evaluation of view of entrance to larynx comparing Miller and Macinthosh blade in adults
timeFrame: immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Łódź
country: Poland
facility: Medical University of Lodz, Poland
Study officials:
References: