Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06466759 |
Other study ID # |
915.982 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 2, 2024 |
Est. completion date |
December 31, 2026 |
Study information
Verified date |
June 2024 |
Source |
University of Turin, Italy |
Contact |
Gerardo Cortese, MD |
Phone |
+39 0116335505 |
Email |
gcortese[@]cittadellasalute.to.it |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The general aim of the study is to observe whether the use of the Mc Grath™ videolaryngoscope
instead of direct laryngoscopy can represent, as in the case of the single-lumen tube, an
added value in the placement of the double-lumen tube for surgical procedures involving
one-lung ventilation, making intubation on the first attempt more likely and quicker.
Secondary objectives include evaluating the presence of an advantage of the Mc Grath™
videolaryngoscope over direct laryngoscopy for the correct placement of the double-lumen
tube, the need for additional maneuvers during the intubation procedure, and the presence of
intra- and post-procedural complications.
Description:
Placement of the double-lumen tube (DLT) can be more challenging because the endobronchial
tube is larger (thus worsening glottic view) and more rigid (increasing the risk of trauma
and reducing maneuverability during placement). An anatomically easy airway can become more
demanding when there's a need to place a double-lumen tube. Success rates and intubation
times can vary significantly. The superiority of videolaryngoscopy (VLS) over direct
laryngoscopy (DL) is clear regarding the placement of the single-lumen endotracheal tube
(SLT). Its use is now "recommended" as the first attempt in anticipated difficult airways and
"suggested" for all routine intubations. To date, 19 prospective randomized controlled trials
have compared the effectiveness of six VLS devices for DLT intubation versus DL in patients
with anticipated non-difficult airways. Key endpoints included glottic view, intubation time,
success rate, intubation difficulty rating, incidence of malpositioning, postoperative sore
throat, hoarseness, procedure-related complications, and intubation-related stress response.
Apart from a superior glottic view with VLS compared to DL, consistent results have not
emerged across different studies. This heterogeneity may be attributed to differences in the
experience of the operators involved, the type of VLS used, and finally the definition of the
primary endpoint. Conducting a randomized controlled study with adequate and larger sample
size than previous ones and a homogeneous population can ascertain whether VLS can represent,
as in the case of SLT, an added value in DLT placement, guiding clinicians towards its
routine use.
It is worth noting that current guidelines on DLT intubation do NOT recommend the "1st
choice" use of VLS, a recommendation already existing for SLT placement. For this reason, in
clinical practice, both devices are effectively used interchangeably, largely based on
individual clinician preferences, which moreover possess comparable expertise in both direct
laryngoscopy and videolaryngoscopy.
Aim: To compare the effectiveness of a single videolaryngoscope, the Mc Grath™, versus direct
laryngoscopy in placing the double-lumen tube in surgery.
Experimental design: Multicentric Randomized Controlled Trial Primary endpoint: evaluation of
the advantage of the Mc Grath™ videolaryngoscope over direct laryngoscopy for double-lumen
tube intubation.
Secondary endpoints: Evaluation of the advantage of the Mc Grath™ videolaryngoscope over
direct laryngoscopy for intra- and post-procedural complications, need for additional
maneuvers, and correct placement of the double-lumen tube.
Study duration: 24 months