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| Name | Class |
|---|---|
| A.O.U. Città della Salute e della Scienza - Molinette Hospital | OTHER |
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The general aim of the study is to observe whether the use of the Mc Grathâ„¢ 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 Grathâ„¢ 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.
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 Grathâ„¢, 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 Grathâ„¢ videolaryngoscope over direct laryngoscopy for double-lumen tube intubation.
Secondary endpoints: Evaluation of the advantage of the Mc Grathâ„¢ 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VOLCANO - double lumen tube placement with direct laryngoscopy | No Intervention | Patients will receive double lumen tube placement with direct laryngoscopy | |
| VOLCANO - double lumen tube placement with videolaryngoscopy | Active Comparator | Patients will receive double lumen tube placement with videolaryngoscopy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mc Grath Videolaryngoscope | Device | Use of Videolaryngoscope with Mc Grath versus direct laryngoscopy |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of partecipant with first pass intubation success | first pass intubation success of the Mc Grathâ„¢ videolaryngoscope over direct laryngoscopy for double-lumen tube intubation. | up to 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Intubation-related complications | Evaluation of the advantage of the Mc Grathâ„¢ videolaryngoscope over direct laryngoscopy for intra- and post-procedural complications, need for additional maneuvers, and correct placement of the double-lumen tube. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gerardo Cortese, MD | Contact | +39 0116335505 | gcortese@cittadellasalute.to.it |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 27, 2024 |
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| Mar 28, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 27, 2024 | Mar 28, 2024 | ICF_001.pdf |