Noninferiority Clinical Trial With Laryngeal Mask and Endotracheal Tube

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Universidad de Antioquia.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Olga Luci-a Giraldo Salazar, Universidad de Antioquia
ClinicalTrials.gov Identifier:
NCT01288248
First received: January 31, 2011
Last updated: July 25, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Laryngospasm
Bradycardia
Device: Airway laryngeal mask classic
Device: endotracheal tube
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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 Noninferiority

Further study details as provided by Universidad de Antioquia:

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

Estimated Enrollment: 338
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Airway laryngeal mask classic
Ventilation with Airway laryngeal mask classic during surgery
Device: Airway laryngeal mask classic

This group includes patients with the randomization process are assigned to use Classic laryngeal mask as a method to secure the airway after induction of anesthesia, which will be maintained during surgery and removed the patient asleep once you are done the surgical procedure to determine the presence or absence of laryngospasm.

The laryngeal mask mark to be used will laryngeal Mask Device ® which comes in different sizes and sterilized in ethylene oxide. The size of the Classic laryngeal mask is used according to the weight assigned

Other Name: airway laryngeal mask proseal
Active Comparator: endotracheal tube
Ventilation with endotracheal tube during surgery
Device: endotracheal tube

This group includes patients with the randomization process are allocated to use endotracheal tube method for securing the airway after induction of anesthesia, which will be maintained during surgery and removed in the awake patient when you finish the surgical procedure to determine the presence or absence of laryngospasm.

The marks of the endotracheal tube will be one of the following: Kendall Curity ®, Well Lead Medical ®, Meditec ®, which are not reusable. The size of the endotracheal tube be allocated according to age.

Other Name: laryngeal 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.

  Eligibility

Ages Eligible for Study:   2 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288248

Locations
Colombia
Hospital Foundation St. Vincent de Paul
Medellin, Antioquia, Colombia, 05001000
Sponsors and Collaborators
Universidad de Antioquia
Investigators
Principal Investigator: Olga Lucia Giraldo Salazar, MD, MsH Foundation Hospital San Vicente de Paul, St. Vincent Foundation
  More Information

No publications provided

Responsible Party: Olga Luci-a Giraldo Salazar, MD, Anestesiologist, Universidad de Antioquia
ClinicalTrials.gov Identifier: NCT01288248     History of Changes
Other Study ID Numbers: Anestudea-001
Study First Received: January 31, 2011
Last Updated: July 25, 2012
Health Authority: Colombia: Institutional Review Board

Keywords provided by Universidad de Antioquia:
Airway
Airway laryngeal mask
Endotracheal tube
Respiration artificial
Laryngospasm
Safety of airway laryngeal mask

Additional relevant MeSH terms:
Laryngismus
Bradycardia
Laryngeal Diseases
Respiratory Tract Diseases
Respiration Disorders
Otorhinolaryngologic Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014