DOuble-Lumen Intubation With VIdeolaryngoscopy

Anesthesia Clinical Trial

— DoLVi  

Official title:

Video Versus Direct Laryngoscopy for Double-lumen Tube Tracheal Intubation in Thoracic Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06401486
• Other study ID #: DoLVi trial
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: May 2024
• Source: Hospital Clinico Universitario de Santiago
• Contact: Manuel Taboada, Ph.D.
• Phone: 0034981950674
• Email: manutabo[@]yahoo.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 916
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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...).

Related Conditions & MeSH terms

• Anesthesia
• Intubation Complication
• Intubation; Difficult or Failed
• Videolaryngoscopy

Intervention

Device:
• Videolaryngoscope
For patients assigned to the videolaryngoscope Group, the operator will use a video laryngoscope on the first laryngoscopy attempt.
• Macintosh laryngoscope
For patients assigned to the laryngoscope Group, the operator will use a Macintosh laryngoscope on the first laryngoscopy attempt.

Locations

Country	Name	City	State
Spain	Complexo Hospitalario Universitario de A Coruña	A Coruña
Spain	Complexo Hospitalario Universitario de Santiago de Compostela	Santiago de Compostela
Spain	Hospital Universitario La Fe de Valencia	Valencia
Spain	Complexo Hospitalario Universitario Vigo	Vigo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinico Universitario de Santiago

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of laryngoscopy attempts	Number of laryngoscopy attempts	Duration of procedure (minutes)
Other	Number of attempts to cannulate the trachea with an endotracheal tube	Number of attempts to cannulate the trachea with an endotracheal tube	Duration of procedure (minutes)
Other	Duration of laryngoscopy and tracheal intubation	The interval (in seconds) between the first insertion of a laryngoscope blade into the mouth and the final placement of a double lumen tube in the trachea.	Duration of procedure (minutes)
Other	Reason for failure to intubate on the first attempt	Reason for failure among those who did not meet the primary outcome (successful intubation on the first attempt): Inadequate view of the larynx; Inability to intubate the trachea with an endotracheal tube; Inability to cannulate the trachea with a bougie; Attempt aborted due to change in patient condition (e.g., worsening hypoxemia, hypotension, bradycardia, vomiting, bleeding); Technical failure of the laryngoscope (e.g., battery, light source, camera, screen); Other	Duration of procedure (minutes)
Other	Operator-assessed difficulty of intubation	Operator-assessed difficulty of intubation; without difficulty; mild difficulty; moderate difficulty; severe difficulty	Duration of procedure (minutes)
Other	Modified Cormack-Lehane grade of glottic view	Modified Cormack-Lehane grade of glottic view: I: full view of the glottis; IIa: partial view of the glottis; IIb: arytenoid or posterior part of the vocal cords just visible; III: only epiglottis visible; IV: neither glottis nor epiglottis visible Cormack-Lehane grade of glottic view	Duration of procedure (minutes)
Other	Need for additional airway equipment	Airway equipment: bougie, stylet, other videolaryngoscope, others.	Duration of procedure (minutes)
Other	Need to change the device for intubation	Need to replace by another videolaryngoscope, a different angled blade, requirement for a fiberoptic bronchoscope...).	Duration of procedure (minutes)
Other	Use of external laryngeal pressure	External laryngeal pressure	Duration of procedure (minutes)
Other	Malposition of the double lumen endotracheal tube	Malposition of the double lumen endotracheal tube	Duration of procedure (minutes)
Other	Incidence of Dysphonia, hoarseness, or sore throat in the first 24 hours.	Incidence of Dysphonia, hoarseness, or sore throat in the first 24 hours.	24 hours after intubation
Primary	Number of intubations with successful intubation on the first attempt	The primary outcome is defined as placement of a double lumen tube in the trachea with a single insertion of a videolaryngoscope blade into the mouth and either a single insertion of a double lumen tube into the mouth.	Duration of procedure (minutes)
Secondary	Successful intubation	Successful placement of a double lumen tube in the trachea	Duration of procedure (minutes)
Secondary	Incidence of "easy intubation"	Easy intubation is defined as a patient with Cormack-Lehane I-II glottic view and intubation on the first attempt.	Duration of procedure (minutes)