Airway Injuries After Intubation Using Videolaryngoscopy Versus Direct Laryngoscopy for Adult Patients Requiring Tracheal Intubation

Airway Complication of Anesthesia Clinical Trial

Official title:

Airway Injuries After Intubation Using Videolaryngoscopy Highly Curved Blades Versus Direct Laryngoscopy for Adult Patients Requiring Tracheal Intubation: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03613103
• Other study ID #: Airway - 001
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: December 1, 2023

Study information

• Verified date: December 2023
• Source: Universidad de Antioquia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 716
• Est. completion date: December 1, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 years of age.
• Scheduled for a procedure or surgery that requires general anesthesia that requires orotracheal intubation.
• Scheduled for non-cardiac surgery.
• Elective surgery.

Exclusion Criteria:

• Women in pregnancy.
• Patient refuses to participate in the study before surgery.
• Patients with predictors of anticipated difficult airway.
• Head and neck surgery.
• Go to Intensive Care Unit with endotracheal intubation.

Related Conditions & MeSH terms

• Airway Complication of Anesthesia
• Airway Trauma

Intervention

Device:
• Video laryngoscopy
Intubation with videolaryngoscopy with highly curved blade
• Direct laryngoscopy
Intubation with direct laryngoscopy with macintosh blade

Locations

Country	Name	City	State
Colombia	Universidad de Antioquia	Medellin	Antioquia

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Antioquia	IPS Universitaria-Universidad de Antioquia

Country where clinical trial is conducted

Colombia, 

References & Publications (34)

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with an airway injury	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.	24 hours
Secondary	Successful intubation at the first attempt	Number of patients with successful intubation at the first attempt.	Immediate postoperative
Secondary	Global of Successful Intubation	Number of patients with successful intubation regardless of the attempts to achieve it.	Immediate postoperative
Secondary	Cormack-lehane visualization	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.	Immediate postoperative
Secondary	Time to achieve orotracheal intubation	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.	Immediate postoperative
Secondary	Post-anesthetic satisfaction	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).	Immediate postoperative
Secondary	Hypoxemia during induction and intubation	Number of patients with hypoxemia during induction and intubation. Hypoxaemia is defined as an oxygen saturation measured with pulse oximetry less than 92%.	Immediate postoperative
Secondary	Bradycardia during induction and intubation	Number of patients with bradycardia during induction and intubation. Bradycardia is defined as a decrease in heart rate of less than 40 beats / minute.	Immediate postoperative
Secondary	Cardiac Arrest	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.	Immediate postoperative