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OpenTrials
Completed

NCT Number: NCT02751047

Manual Ventilation Versus Pressure Controlled Mechanical Ventilation in Children

The investigator will compare the feasibility of manual ventilation and pressure-controlled mechanical ventilation during facemask ventilation in children. The hypothesis is that the incidence of gastric insufflation would be lower during pressure-controlled mechanical ventilation when compared to manual ventilation.

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Key information

Conditions

Ventilation Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

1 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children with American Society of Anesthesiologist (ASA) physical status 1, 2
  • Children with normal body mass index

Exclusion criteria

  • Difficult airway management
  • pulmonary disease
  • upper respiratory infection
  • risk of pulmonary aspiration
  • intestinal obstruction or abdominal distension
  • stroke history or moyamoya disease

Treatment and study plan

manual ventilation

Other

Facemask ventilation is performed by manual bagging with reservoir bag.

Pressure controlled mechanical ventilation

Other

Facemask ventilation is performed with mechanical ventilator by pressure controlled mode.

Primary outcomes

  1. Incidence of gastric insufflation

    Time frame: During facemask ventilation (90 seconds)

Secondary outcomes

  1. The number of patients with adequate tidal volume

    Time frame: During facemask ventilation (90 seconds)

    Tidal volume of 6 - 10 ml/kg

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Comparison Between Pressure Controlled Mechanical Ventilation and Manual Ventilation During Mask Ventilation for Induction of Anesthesia in Children

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Apr 26, 2016
Registry last updated
Aug 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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