Efficacy of Mechanical Ventilation With Facial Mask to Reduce Gastric Insufflation

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  Recruiting
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
  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

Resource links provided by NLM:


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

  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
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: 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 September 18, 2014