Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06401486
Other study ID # DoLVi trial
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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...).

Study Design


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)
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04580030 - Tricuapid Annular Plane Sistolic Excursion Before General Anesthesia Can Predict Hypotension After Induction
Active, not recruiting NCT04279054 - Decreased Neuraxial Morphine After Cesarean Delivery Early Phase 1
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Recruiting NCT04099693 - A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP
Terminated NCT02481999 - Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
Completed NCT04235894 - An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia
Recruiting NCT05525104 - The Effect of DSA on Recovery of Anaesthesia in Children (Het Effect Van DSA op Het Herstel na Anesthesie Bij Kinderen). N/A
Recruiting NCT05024084 - Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery and Anesthetic Depth Phase 4
Completed NCT04204785 - Noise in the OR at Induction: Patient and Anesthesiologists Perceptions N/A
Completed NCT03277872 - NoL, HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope N/A
Terminated NCT03940651 - Cardiac and Renal Biomarkers in Arthroplasty Surgery Phase 4
Terminated NCT02529696 - Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Terminated NCT03704285 - Development of pk/pd Model of Propofol in Patients With Severe Burns
Recruiting NCT05259787 - EP Intravenous Anesthesia in Hysteroscopy Phase 4
Completed NCT02894996 - Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient? N/A
Completed NCT05386082 - Anesthesia Core Quality Metrics Consensus Delphi Study
Terminated NCT03567928 - Laryngeal Mask in Upper Gastrointestinal Procedures N/A
Recruiting NCT06074471 - Motor Sparing Supraclavicular Block N/A
Completed NCT04163848 - CARbon Impact of aNesthesic Gas