UnknownPhase 3

Noninferiority Clinical Trial With Laryngeal Mask and Endotracheal Tube

Colombia338 participantsStarted 2012-01

Plain-language 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.

Who can participate

Age range2 Years – 14 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Laryngospasm clinically manifested as inspiratory stridor and/or expiratory, no breath sounds, paradoxical movement of the thorax and abdomen and desaturation, bradycardia, central cyanosis.

Timeframe: The appearance of the outcome will be measured from anesthetic induction until the patient is fully awake

Trial details

NCT IDNCT01288248

SponsorUniversidad de Antioquia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-10

View on ClinicalTrials.gov More Laryngospasm trials