Clinical trial NCT06401486: DOuble-Lumen Intubation with VIdeolaryngoscopy
Official title: Video Versus Direct Laryngoscopy for Double-lumen Tube Tracheal Intubation in Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intubation Complication
Intubation; Difficult or Failed
Anesthesia
Videolaryngoscopy
Keywords: videolaryngoscopy
tracheal intubation
Lead sponsor: Hospital Clinico Universitario de Santiago
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 916
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older.
* Patients admitted to any of the participating hospitals in the study who are undergoing thoracic surgery.
* Need for intubation with a double-lumen tube.

Exclusion Criteria:

* Pregnant or lactating women.
* Individuals who do not have the capacity to understand their participation in the study.
* Need for tracheal intubation with a device other than videolaryngoscopy or direct laryngoscopy (fiberoptic bronchoscope, tracheostomy...).

Primary outcomes:
measure: Number of intubations with successful intubation on the first attempt
timeFrame: Duration of procedure (minutes)
Secondary outcomes:
measure: Successful intubation
timeFrame: Duration of procedure (minutes)
measure: Incidence of "easy intubation"
timeFrame: Duration of procedure (minutes)
Other outcomes:
measure: Number of laryngoscopy attempts
timeFrame: Duration of procedure (minutes)
measure: Number of attempts to cannulate the trachea with an endotracheal tube
timeFrame: Duration of procedure (minutes)
measure: Duration of laryngoscopy and tracheal intubation
timeFrame: Duration of procedure (minutes)
measure: Reason for failure to intubate on the first attempt
timeFrame: Duration of procedure (minutes)
measure: Operator-assessed difficulty of intubation
timeFrame: Duration of procedure (minutes)
measure: Modified Cormack-Lehane grade of glottic view
timeFrame: Duration of procedure (minutes)
measure: Need for additional airway equipment
timeFrame: Duration of procedure (minutes)
measure: Need to change the device for intubation
timeFrame: Duration of procedure (minutes)
measure: Use of external laryngeal pressure
timeFrame: Duration of procedure (minutes)
measure: Malposition of the double lumen endotracheal tube
timeFrame: Duration of procedure (minutes)
measure: Incidence of Dysphonia, hoarseness, or sore throat in the first 24 hours.
timeFrame: 24 hours after intubation
Locations:
city: A Coruña
country: Spain
facility: Complexo Hospitalario Universitario de A Coruña
city: Santiago de Compostela
country: Spain
facility: Complexo Hospitalario Universitario de Santiago de Compostela
city: Valencia
country: Spain
facility: Hospital Universitario La Fe de Valencia
city: Vigo
country: Spain
facility: Complexo Hospitalario Universitario Vigo
Study officials:
affiliation: Clinical University Hospital of Santiago de Compostela
name: Manuel Taboada, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karczewska K, Bialka S, Smereka J, Cyran M, Nowak-Starz G, Chmielewski J, Pruc M, Wieczorek P, Peacock FW, Ladny JR, Szarpak L. Efficacy and Safety of Video-Laryngoscopy versus Direct Laryngoscopy for Double-Lumen Endotracheal Intubation: A Systematic Review and Meta-Analysis. J Clin Med. 2021 Nov 25;10(23):5524. doi: 10.3390/jcm10235524.
citation: Kim YS, Song J, Lim BG, Lee IO, Won YJ. Different classes of videoscopes and direct laryngoscopes for double-lumen tube intubation in thoracic surgery: A systematic review and network meta-analysis. PLoS One. 2020 Aug 28;15(8):e0238060. doi: 10.1371/journal.pone.0238060. eCollection 2020.
citation: Liu TT, Li L, Wan L, Zhang CH, Yao WL. Videolaryngoscopy vs. Macintosh laryngoscopy for double-lumen tube intubation in thoracic surgery: a systematic review and meta-analysis. Anaesthesia. 2018 Aug;73(8):997-1007. doi: 10.1111/anae.14226. Epub 2018 Feb 6.