Noninferiority Clinical Trial With Laryngeal Mask and Endotracheal Tube

Phase 3

• Conditions: Laryngospasm; Bradycardia
• Interventions: Device: Airway laryngeal mask classic; Device: endotracheal tube

• Registration Number: NCT01288248
• Lead Sponsor: Universidad de Antioquia

Brief Summary

The purpose of this study is to determine whether the use of laryngeal mask classic as method for securing the airway in the population of 2 years to 14 years is associated with risk of laryngospasm as compared with the use of endotracheal tube.

Detailed Description

Laryngospasm, defined as closure of the glottis as a protective reflex secondary to abnormal stimulation (7), with a reported incidence in the general population of 8.7 per 1000 patients undergoing surgical procedures (8), is considered the most common event among the complications in the management of pediatric airway, causing 40% of obstructive events after extubation (7-8), with incidents reported in the American pediatric population from 0.4% to 14% (8-9) for population under 6 years and 3.6% in \> 6 years. Among the risk factors associated with the development of laryngospasm and anesthesia in children are: age, ASA (4), upper respiratory infection (10), among others, however in recent years has gained interest and generated dispute the association between this outcome and the type of device used to secure the airway during anesthesia. Although the endotracheal tube device is considered the "gold standard" for airway management, this has been associated with an increased incidence of laryngospasm (8), explained this phenomenon, apparently by direct stimulation because the tube into the larynx and trachea, which triggers, in theory, a posterior laryngeal reflex intense (11).

In recent years, with the advent of new devices for securing the airway, especially supraglottic use type Classic Laryngeal Mask (LM), it was thought that the main trigger of laryngospasm, laryngeal and tracheal stimulation caused by the endotracheal tube (ETT), would be resolved and will decrease the incidence of complications in the pediatric population; however, three recent prospective studies (10-11-12) is no statistically significant difference in incidence of laryngospasm among laryngeal mask and endotracheal tube. By contrast, two retrospective studies (6.4) have shown increased incidence of laryngospasm compared to ETT in children. In 2002, one of the aforementioned prospective studies (11), found an incidence of laryngospasm 11.2% versus 16.9% for ETT versus ML, respectively, but without an increase in relative risk statistically significant when comparing the ML to ETT.

In view of these findings and considering that most studies in this respect seem to have technical and methodological limitations, our objective is to determine by controlled clinical trial non inferiority the risk of laryngospasm with the endotracheal tube vs a device supraglottic, Classic Laryngeal Mask type as a method of airway patency in the pediatric population, assuming that the risk of laryngospasm with both devices is equal.

Study Timeline

• Study First Submitted: 2011-01-31
• Study First Submitted QC: 2011-01-31
• Study First Posted: 2011-02-02
• Study Start: 2012-01
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-25
• Last Update Posted: 2012-07-26
• Primary Completion: 2013-10
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 338

Inclusion Criteria

• ASA I and III children, 1-14 years of age
• Children scheduled for surgery or therapeutic procedures under general anesthesia and fasting as defined in the fasting guidelines
• Responsible adult patients whose accept and sign the informed consent of study

Exclusion Criteria

• Surgery of the head, neck, chest and/or abdomen (except the abdominal wall)
• Position different than the supine in surgery
• Malformations or anatomic abnormalities of the face and airway
• Procedures over 3 hours
• Patients with pulmonary aspiration risk: morbid obesity, intestinal obstruction, gastrointestinal bleeding, gastroparesis, gastroesophageal reflux
• Patients with limited mouth opening or cervical spine extension and classified as difficult airway

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Airway laryngeal mask classic	Airway laryngeal mask classic	Ventilation with Airway laryngeal mask classic during surgery
endotracheal tube	endotracheal tube	Ventilation with endotracheal tube during surgery

Primary Outcome Measures

Name	Time	Method
Laryngospasm clinically manifested as inspiratory stridor and/or expiratory, no breath sounds, paradoxical movement of the thorax and abdomen and desaturation, bradycardia, central cyanosis.	The appearance of the outcome will be measured from anesthetic induction until the patient is fully awake	It should be noted that once the subject of study presents the primary outcome may end up changing the device to improve ventilation.

Secondary Outcome Measures

Name	Time	Method
Desaturation defined as SaO2 < 90% in pulse oximetry associated with laryngospasm	from anesthetic induction until the patient is fully awake
Presence of bradycardia in the cardioscope as reported for the age.	from anesthetic induction until the patient is fully awake

Trial Locations

Locations (1)

Hospital Foundation St. Vincent de Paul; 🇨🇴 Medellin, Antioquia, Colombia