Determination of Optimal Mask Ventilation Mode in Pediatrics Using Real-time Ultrasonography

Ultrasound Clinical Trial

Official title:

Determination of Optimal Mask Ventilation Mode in Pediatrics Using Real-time Ultrasonography

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03881033
• Other study ID #: AJIRB-MED-OBS-18-192
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: November 30, 2019

Study information

• Verified date: March 2019
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The peak inspiratory pressure during face mask ventilation for general anesthesia is closely correlated with gastric insufflation. High pressure increases the amount of air in stomach and low pressure could decrease the tidal volume, therefore ideal pressure means the pressure guarantee adequate ventilation with minimal gastric insufflation.

The aim of this study is finding the proper pressure and mode of face mask ventilation in pediatric patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: November 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

Inclusion Criteria:

• The ASA class I,II and 1-5 years pediatric patients need general anesthesia

Exclusion Criteria:

• Oropharyngeal or facial pathology accompanied

• Obese (BMI > 30 kg/m2)

• GI tract obstruction

Related Conditions & MeSH terms

• Ultrasound
• Ventilator Lung

Intervention

Other:
• Peep 5cmH2O
Face mask ventilation with peak inspiratory pressure according to the group P7+5 means face mask ventilation with peak inspiratory pressure 7cmH2O plus PEEP 5 cmH2O.
• Peak inspiratory pressure
Face mask ventilation with peak inspiratory pressure according to the group P12 means face mask ventilation with peak inspiratory pressure 12cmH2O without PEEP.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The degree of atelectasis	After intubation, confirming endotracheal intubation, the ventilator is connected and turned on.	1min after ventilator-on
Secondary	The incidence of gastric insufflation		During face mask ventilation