Efficacy of Mechanical Ventilation With Facial Mask to Reduce Gastric Insufflation

NCT01652924 | Unknown DMC

• 1 other identifier: Anestesia002
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Insufflation

Keywords

mechanical ventilation; manual ventilation

Outcome Measures

Primary Outcomes (1)

• Gastric insufflation determined by continuous epigastric auscultation until to secure the airway.

  Intervention end up once the anesthesiologist to secure airway patient and during this time the investigator will auscultate the epigastrium

  From anesthetic induction until to secure airway with endotracheal tube, an expected average of 5 minutes

Secondary Outcomes (1)

• Gastric insufflation determined by aspiration with orogastric tube after to secure the airway

  First 3 minutes after to secure airway with endotracheal tube

Other Outcomes (1)

• Gastric insufflation determined by measurement abdominal circumference until to secure the airway and remove orogastric tube.

  Before anesthetic induction until to secure airway with endotracheal tube and to remove orogastric tube, an expected average of 20 minutes

Study Arms (2)

Mechanical ventilation

EXPERIMENTAL

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

Manual ventilation

ACTIVE COMPARATOR

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

Interventions

Mechanical ventilation with facial mask DEVICE

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 .

Also known as: Mechanical ventilation during anesthetic induction

Mechanical ventilation

Manual ventilation with facial mask DEVICE

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.

Also known as: Manual ventilation during anesthetic induction

Manual ventilation

Eligibility Criteria

• Age: 1 Month - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Antioquia: lead

Study Sites (1)

San Vincent Foundation, San Vincent Hospital

Medellín, Antioquia, 05001000, Colombia

RECRUITING

MeSH Terms

Interventions

Respiration, Artificial

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Study Officials

• Olga Lucia Giraldo, MD

  Antioquia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olga Lucia Giraldo, MD

CONTACT

574 2637900; olgiraldos@une.net.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Anesthesiologist

Study Record Dates

• First Submitted: July 24, 2012
• First Posted: July 30, 2012
• Study Start: May 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: July 30, 2012

Record last verified: 2012-07

Locations

CO (1)