NCT01288248

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
338

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 2, 2011

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

July 26, 2012

Status Verified

July 1, 2012

Enrollment Period

1.8 years

First QC Date

January 31, 2011

Last Update Submit

July 25, 2012

Conditions

LaryngospasmBradycardia

Keywords

AirwayAirway laryngeal maskEndotracheal tubeRespiration artificialLaryngospasmSafety of airway laryngeal mask

Outcome Measures

Primary Outcomes (1)

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

    It should be noted that once the subject of study presents the primary outcome may end up changing the device to improve ventilation.

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

Secondary Outcomes (2)

  • 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

Study Arms (2)

Airway laryngeal mask classic

EXPERIMENTAL

Ventilation with Airway laryngeal mask classic during surgery

Device: Airway laryngeal mask classic

endotracheal tube

ACTIVE COMPARATOR

Ventilation with endotracheal tube during surgery

Device: endotracheal tube

Interventions

Airway laryngeal mask classicDEVICE

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

Also known as: airway laryngeal mask proseal
Airway laryngeal mask classic
endotracheal tubeDEVICE

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.

Also known as: laryngeal tube
endotracheal tube

Eligibility Criteria

Age2 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Foundation St. Vincent de Paul

Medellín, Antioquia, 05001000, Colombia

Location

MeSH Terms

Conditions

LaryngismusBradycardia

Condition Hierarchy (Ancestors)

Vocal Cord DysfunctionLaryngeal DiseasesRespiratory Tract DiseasesRespiration DisordersOtorhinolaryngologic DiseasesArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Olga Lucia Giraldo Salazar, MD, MsH

    Foundation Hospital San Vicente de Paul, St. Vincent Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Anestesiologist

Study Record Dates

First Submitted

January 31, 2011

First Posted

February 2, 2011

Study Start

January 1, 2012

Primary Completion

October 1, 2013

Study Completion

December 1, 2013

Last Updated

July 26, 2012

Record last verified: 2012-07

Locations

CO(1)