Clinical Trial: Noninferiority Clinical Trial With Laryngeal Mask and Endotracheal Tube

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: The Risk of Laryngospasm in Children is Similar to the Use of the Laryngeal Mask and the Endotracheal Tube in Children 2 Years to 14 Years: Clinical Trial Randomized Nonin

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 Summary:

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 prospectiv
Sponsor: Universidad de Antioquia

Current Primary Outcome: Laryngospasm clinically manifested as inspiratory stridor and/or expiratory, no breath sounds, paradoxical movement of the thorax and abdomen and desaturation, bradycardia, central cyanosis. [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Universidad de Antioquia

Dates:
Date Received: January 31, 2011
Date Started: January 2012
Date Completion: December 2013
Last Updated: July 25, 2012
Last Verified: July 2012