Efficacy of Mechanical Ventilation With Facial Mask to Reduce Gastric Insufflation

This study is currently recruiting participants.

Verified July 2012 by Universidad de Antioquia

Sponsor:

Information provided by (Responsible Party):

Olga Luci-a Giraldo Salazar, Universidad de Antioquia

ClinicalTrials.gov Identifier:

NCT01652924

First received: July 24, 2012

Last updated: July 27, 2012

Last verified: July 2012

History of Changes

Purpose

The purpose of this study is to determine whether mechanical ventilation with facial mask during induction anesthesia in the population of 1month to 14years is associated with less risk of gastric insufflations as compared with manual ventilation.

Condition	Intervention
Gastric Insufflation	Device: Mechanical ventilation with facial mask Device: Manual ventilation with facial mask

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Efficacy and Safety of Pressure-controlled Ventilation Compared With Manual Ventilation to Reduce Gastric Insufflation During Induction of Anesthesia in Children: Controlled Trial Randomized, Double-blind

Further study details as provided by Universidad de Antioquia:

Primary Outcome Measures:

Gastric insufflation determined by continuous epigastric auscultation until to secure the airway. [ Time Frame: From anesthetic induction until to secure airway with endotracheal tube, an expected average of 5 minutes ] [ Designated as safety issue: Yes ]
Intervention end up once the anesthesiologist to secure airway patient and during this time the investigator will auscultate the epigastrium

Secondary Outcome Measures:

Gastric insufflation determined by aspiration with orogastric tube after to secure the airway [ Time Frame: First 3 minutes after to secure airway with endotracheal tube ] [ Designated as safety issue: Yes ]
Intervention end up once the anesthesiologist to secure airway patient and complete aspiration with orogastric tube.

Other Outcome Measures:

Gastric insufflation determined by measurement abdominal circumference until to secure the airway and remove orogastric tube. [ Time Frame: Before anesthetic induction until to secure airway with endotracheal tube and to remove orogastric tube, an expected average of 20 minutes ] [ Designated as safety issue: No ]
Intervention end up once the anesthesiologist to secure airway patient and remove orogastric tube.

Estimated Enrollment:	180
Study Start Date:	May 2012
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Mechanical ventilation 1: Active Comparator Children 1 month-14 years of age Intervention:Mechanical ventilation with facial mask during anesthetic induction	Device: Mechanical ventilation with facial mask This group includes patients with the randomization process are assigned to mechanical ventilation with facial mask during induction of anesthesia, which will be maintained until to secure airway with endotracheal tube to determine the presence of gastric insufflation. The size of the facial mask is used according to the age and ventilation parameters are: inspiratory pressure 10 cmH2O, PEEP 5 cmH2O, respiratory frequency and relation I/E according to age . Other Name: Mechanical ventilation during anesthetic induction
Active Comparator: Manual ventilation 2: Active Comparator Children 1 month-14 years of age Intervention: Manual ventilation with facial mask during anesthetic induction	Device: Manual ventilation with facial mask This group includes patients with the randomization process are allocated to manual ventilation with facial mask during induction of anesthesia, which will be maintained until to secure airway with endotracheal tube to determine the presence of gastric insufflation. The size of the facial mask is used according to the age and ventilator y parameters are selected by the anesthesiologist. Other Name: Manual ventilation during anesthetic induction

Arms

Assigned Interventions

Experimental: Mechanical ventilation

1: Active Comparator Children 1 month-14 years of age Intervention:Mechanical ventilation with facial mask during anesthetic induction

Device: Mechanical ventilation with facial mask

This group includes patients with the randomization process are assigned to mechanical ventilation with facial mask during induction of anesthesia, which will be maintained until to secure airway with endotracheal tube to determine the presence of gastric insufflation. The size of the facial mask is used according to the age and ventilation parameters are: inspiratory pressure 10 cmH2O, PEEP 5 cmH2O, respiratory frequency and relation I/E according to age .

Other Name: Mechanical ventilation during anesthetic induction

Active Comparator: Manual ventilation

2: Active Comparator Children 1 month-14 years of age Intervention: Manual ventilation with facial mask during anesthetic induction

Device: Manual ventilation with facial mask

This group includes patients with the randomization process are allocated to manual ventilation with facial mask during induction of anesthesia, which will be maintained until to secure airway with endotracheal tube to determine the presence of gastric insufflation.

The size of the facial mask is used according to the age and ventilator y parameters are selected by the anesthesiologist.

Other Name: Manual ventilation during anesthetic induction

Show Detailed Description

Eligibility

Ages Eligible for Study:	1 Month to 14 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

ASA I and III children, 1 month-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:

Patients with limited mouth opening or cervical spine extension and classified as difficult airway
Respiratory diseases
Children with orogastric or nasogastric tubes
Children with gastrostomies
Patients with pulmonary aspiration risk: morbid obesity, intestinal obstruction, gastrointestinal bleeding, gastroparesis, gastroesophageal reflux.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01652924

Contacts

Contact: Olga Lucia Giraldo, MD

574 2637900

olgiraldos@une.net.co

Locations

Colombia
San Vincent Foundation, San Vincent Hospital	Recruiting
Medellin, Antioquia, Colombia, 05001000
Contact: Olga Lucia Giraldo, MD 574 2637900 olgiraldos@une.net.co
Principal Investigator: Olga Lucia Giraldo, MD
Sub-Investigator: Monica Lucia Soto, MD
Sub-Investigator: Sandra Diaz, MD
Sub-Investigator: Felipe Posada, MD

Sponsors and Collaborators

Universidad de Antioquia

Investigators

Principal Investigator:

Olga Lucia Giraldo, MD

Antioquia University

More Information

No publications provided

Responsible Party:	Olga Luci-a Giraldo Salazar, MD, Anesthesiologist, Universidad de Antioquia
ClinicalTrials.gov Identifier:	NCT01652924 History of Changes
Other Study ID Numbers:	Anestesia002
Study First Received:	July 24, 2012
Last Updated:	July 27, 2012
Health Authority:	Colombia: Institutional Review Board

Keywords provided by Universidad de Antioquia:

mechanical ventilation
manual ventilation

Additional relevant MeSH terms:

Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013

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