Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06401486
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-05-02
Brief Title:
DOuble-Lumen Intubation With VIdeolaryngoscopy
Sponsor:
Hospital Clinico Universitario de Santiago
Organization:
Hospital Clinico Universitario de Santiago
Study Overview
Official Title:
Video Versus Direct Laryngoscopy for Double-lumen Tube Tracheal Intubation in Thoracic Surgery
Status:
RECRUITING
Status Verified Date:
2024-09
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:
DoLVi
Brief Summary:
Tracheal intubation TI is one of the fundamental and most recognized techniques in Anesthesiology also essential in all units treating urgent pathology and critical patients It involves advancing a tube through the vocal cords into the trachea to ventilate the patient In thoracic surgery it is often necessary to achieve lung isolation ventilating only one lung while the operated lung remains collapsed and immobile To achieve this it is common to intubate the patient with a special tube a double-lumen tube DLT larger than usual because it provides two ventilation channels one for each lung
Tracheal intubation with a DLT presents some peculiarities its larger size and stiffness make manipulation and orientation in the oropharynx difficult It has a curve at its distal end the bronchial lumen designed to slide into the left or right main bronchus as needed The fact that the DLT passes between the vocal cords does not ensure its proper placement and function Therefore DLT intubation requires practice and experience both to slide it between the vocal cords and to position it properly
The classic technique for DLT intubation is Direct Laryngoscopy DL A traditional laryngoscope with a Macintosh blade is used to move the upper airway structures aside to allow direct visualization of the glottis In recent years to facilitate tracheal intubation different videolaryngoscopes have appeared A videolaryngoscope is a device similar to a traditional laryngoscope that allows thanks to an image sensor located at its end indirect visualization of the glottis on an integrated or external screen
There is strong evidence for the benefit of using a VL over traditional DL in single-tube intubation in adult patients However although the use of VL for DLT intubation is becoming more common there are few studies with small sample sizes comparing VL to DL for DLT intubation so the evidence of its advantages or disadvantages is of low quality It could improve glottic exposure and the percentage of success on the first attempt although there is a possibility of increased tube malposition incidence and delayed intubation
Therefore Investigators propose a prospective multicenter randomized study comparing the traditional Macintosh blade laryngoscope direct laryngoscopy with the videolaryngoscope to facilitate orotracheal intubation with double-lumen tube in patients scheduled for thoracic surgery requiring lung isolation
Tracheal intubation with a DLT presents some peculiarities its larger size and stiffness make manipulation and orientation in the oropharynx difficult It has a curve at its distal end the bronchial lumen designed to slide into the left or right main bronchus as needed The fact that the DLT passes between the vocal cords does not ensure its proper placement and function Therefore DLT intubation requires practice and experience both to slide it between the vocal cords and to position it properly
The classic technique for DLT intubation is Direct Laryngoscopy DL A traditional laryngoscope with a Macintosh blade is used to move the upper airway structures aside to allow direct visualization of the glottis In recent years to facilitate tracheal intubation different videolaryngoscopes have appeared A videolaryngoscope is a device similar to a traditional laryngoscope that allows thanks to an image sensor located at its end indirect visualization of the glottis on an integrated or external screen
There is strong evidence for the benefit of using a VL over traditional DL in single-tube intubation in adult patients However although the use of VL for DLT intubation is becoming more common there are few studies with small sample sizes comparing VL to DL for DLT intubation so the evidence of its advantages or disadvantages is of low quality It could improve glottic exposure and the percentage of success on the first attempt although there is a possibility of increased tube malposition incidence and delayed intubation
Therefore Investigators propose a prospective multicenter randomized study comparing the traditional Macintosh blade laryngoscope direct laryngoscopy with the videolaryngoscope to facilitate orotracheal intubation with double-lumen tube in patients scheduled for thoracic surgery requiring lung isolation
Detailed Description:
The purpose of this prospective multicenter randomized study is to compare successful intubation on the first attempt with the Macintosh laryngoscope vs the videolaryngoscope for double-lumen tube tracheal intubation in thoracic surgery Investigators hypothesize that tracheal intubation using the videolaryngoscope will improve the frequency of successful intubation on the first attempt
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