Airway Injuries After Intubation Using Videolaryngoscopy Versus Direct Laryngoscopy for Adult Patients Requiring Tracheal Intubation
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|ClinicalTrials.gov Identifier: NCT03613103|
Recruitment Status : Recruiting
First Posted : August 2, 2018
Last Update Posted : December 2, 2019
Abstract Background Successful tracheal intubation during general anesthesia requires a direct laryngoscope to retract the tongue and soft tissues of the mouth to achieve a line of sight for the larynx. Generally, Macintosh blade laryngoscopy is used to achieve the tracheal intubation. However, difficulties with the tracheal intubation arise the need to use alternative laryngoscopes that use digital or fiberoptic technology, to improve the larynx visibility. Among these devices, highly curved blade videolaryngoscope uses a curved blade to retract the soft tissues of floor of the mouth and transmits a video image to a screen, achieving better larynx visibility. Also, the decrease of the force in the soft tissues with videolaryngoscope could reduce airway injures.
Objectives Our primary objective is to assess whether use of videolaryngoscopy using highly curved blades for tracheal intubation in adults requiring general anesthesia reduces risk of airways injuries compared with Macintosh direct laryngoscopy. Our secondary aim is to assess postoperative satisfaction of the patients, successful intubation at the first attempt, successful global intubation, degree of larynx visibility according to classification Cormack - Lehane and time taken to perform intubation in videolaryngoscopy vs direct laryngoscopy. Finally, we assess the risk of presenting serious adverse event with the use of videolaryngoscopy compared with Macintosh laryngoscopy in hypoxemia, bradycardia and heart arrest.
|Condition or disease||Intervention/treatment||Phase|
|Airway Trauma Airway Complication of Anesthesia||Device: Video laryngoscopy Device: Direct laryngoscopy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||716 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A single-center randomized study is performed including non-cardiac surgical patients without predictable risk of difficult mask ventilation or of difficult tracheal intubation. For direct laryngoscopy group, we use a Macintosh blade and for videolaryngoscopy group we use videolaryngoscopy highly curved blade. Induction of anesthesia is performed using myorelaxation with rocuronium. We record each five minute the vital signs in the anesthesia record. The primary outcome is observed injuries in the mucosa of the airway: Erythema, edema, ecchymosis, laceration, excoriation and / or hematoma. Injuries to dental pieces: Partial and / or total loss of tooth integrity, loosening of dental piece, damage to dental and / or aesthetic prosthetic material. Laryngeal lesions: Edema, laceration, excoriation, erythema, ecchymosis and / or bleeding pharyngeal laryngeal mucosa, arytenoid luxation. Post-intubation symptoms: Sore throat, dysphonia and / or aphonia.|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
Participants will be assigned at the time of anesthetic induction in the surgery room. The allocation to the direct laryngoscopy group and the video laryngoscopy will be 1: 1 randomly using permuted blocks, generated by a computer operated by an external assistant to the investigation. The size of the blocks will be between 4, 6, and 8.
A person external to the research group will be responsible for concealment of allocation through opaque and sealed envelopes, listed sequentially.
|Official Title:||Airway Injuries After Intubation Using Videolaryngoscopy Highly Curved Blades Versus Direct Laryngoscopy for Adult Patients Requiring Tracheal Intubation: a Randomized Controlled Trial|
|Actual Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||June 1, 2020|
|Estimated Study Completion Date :||June 1, 2020|
Active Comparator: Direct laryngoscopy
Intubation with direct laryngoscopy (Conventional Intubation)
Device: Direct laryngoscopy
Intubation with direct laryngoscopy with macintosh blade
Intubation with videolaryngoscopy (Assisted video intubation)
Device: Video laryngoscopy
Intubation with videolaryngoscopy with highly curved blade
- Number of patients with an airway injury [ Time Frame: 24 hours ]
Airway injury will be a composite outcome as follow: Injury in the oral cavity or injury in the laryngopharynx.
These injuries will be evaluated using a digital camera of the oral cavity (fiber optical camera) in the immediate POP.
A patient will be considered positive for the outcome If he/she has at least one of the following findings: Erythema, edema, ecchymosis, laceration, excoriation and / or hematoma in labial, jugal, gingival, lingual mucosa, hard and soft palate; Dental pieces injury: partial and / or total loss of the integrity of the dental piece; Larynx lesions: Edema, laceration, excoriation, erythema, ecchymosis and / or bleeding of pharyngeal laryngeal mucosa.
- Successful intubation at the first attempt [ Time Frame: Immediate postoperative ]Number of patients with successful intubation at the first attempt.
- Global of Successful Intubation [ Time Frame: Immediate postoperative ]Number of patients with successful intubation regardless of the attempts to achieve it.
- Cormack-lehane visualization [ Time Frame: Immediate postoperative ]Degree of Cormack-lehane visualization in each patient. The degree of Cormack-Lehane visualization will be measured from I to IV in relation to the visible portion of the glottis; Grade I with total visualization and Grade IV without visualization of glottis.
- Time to achieve orotracheal intubation [ Time Frame: Immediate postoperative ]Time measured in seconds to achieve orotracheal intubation in each patient. The time interval is determined from the beginning of laryngoscopy by the anesthesiologist until the verification of tracheal intubation by capnography.
- Post-anesthetic satisfaction [ Time Frame: Immediate postoperative ]Post-anesthetic satisfaction in each patient. The Quality of Recovery scale 40 will be used to determine the degree of patient satisfaction, according to the overall and subglobal score, defined by five dimensions: patient support, comfort, emotional, physical independence and pain (includes anatomical airway site).
- Hypoxemia during induction and intubation [ Time Frame: Immediate postoperative ]Number of patients with hypoxemia during induction and intubation. Hypoxaemia is defined as an oxygen saturation measured with pulse oximetry less than 92%.
- Bradycardia during induction and intubation [ Time Frame: Immediate postoperative ]Number of patients with bradycardia during induction and intubation. Bradycardia is defined as a decrease in heart rate of less than 40 beats / minute.
- Cardiac Arrest [ Time Frame: Immediate postoperative ]Number of patients presenting cardiac arrest. Cardiac arrest is defined as the presence of any malignant rhythm: Ventricular tachycardia, ventricular fibrillation, asystole or pulseless electrical activity plus loss of carotid pulse for more than 10 seconds.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03613103
|Universidad de Antioquia||Recruiting|
|Medellin, Antioquia, Colombia|
|Contact: Fabian Casas, MD 054 4441333 ext 2510 firstname.lastname@example.org|