Ignite Creation Date:
2024-07-17 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466759
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-06-05
Brief Title:
Videolaryngoscopy vs Direct Laryngoscopy for Double Lumen Tube Lumen Tube Placement - A Multicentre Randomized-controlled Trial VOLCANO Study
Sponsor:
Luca Brazzi
Organization:
University of Turin Italy
Study Overview
Official Title:
VideolaryngOscopy With Mc Grath vs Direct LaryngosCopy for the Positioning of A Double lumeN endOtracheal Tube VOLCANO Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VOLCANO
Brief 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
Detailed 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 theres 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None