Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05494463 |
| Other study ID # |
RNN/103/22/KE |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 20, 2022 |
| Est. completion date |
February 1, 2023 |
Study information
| Verified date |
July 2022 |
| Source |
Medical University of Lodz |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
