Exploration of the Appropriate Combination of Positive End Expiratory Pressure and Tidal Volume Using the Intratidal Compliance Volume Profile in Children

Respiratory Compliance Clinical Trial

Official title:

Exploration of the Appropriate Combination of Positive End Expiratory Pressure and Tidal Volume Using the Intratidal Compliance-volume Profile in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04633720
• Other study ID #: H2009-175-1162
• Status: Completed
• Phase: N/A
• Start date: December 2, 2020
• Est. completion date: May 30, 2021

Study information

• Verified date: May 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In children under 6 years of age undergoing regular surgery during general anesthesia, the intratidal compliance profile is evaluated when different tidal volumes are applied at different positive end expiratory pressures.

Then determine the most appropriate combination of positive end-tidal pressure and tidal volume.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 6 Years

Eligibility

Inclusion Criteria:

• Children undergoing surgery > 1 hour under general anesthesia

• Children = 6 years

• American society of anesthesiology physical status I, II

Exclusion Criteria:

• Previous lung surgery

• Bronchopulmonary dysplasia, respiratory distress syndrome

• Other interstitial lung disease

• Laparoscopic surgery

• Thoracic surgery, abdominal surgery

Related Conditions & MeSH terms

• Respiratory Compliance

Intervention

Other:
• Changes in positive end-expiratory pressure and tidal volume
When the patient is in the supine position 10 minutes after induction of anesthesia, the following 4 mechanical ventilator settings are applied to the patients in order. Positive end-expiratory pressure 8 cmH2O, tidal volume 8 ml/kg Positive end-expiratory pressure 10 cmH2O, tidal volume 5 ml/kg Positive end-expiratory pressure 10 cmH2O, tidal volume 8 ml/kg Positive end-expiratory pressure 12 cmH2O, tidal volume 5 ml/kg

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intratidal compliance profiles in each ventilator settings	The investigators will determine Intratidal compliance profile using the changes in compliance over time; --> I, merely increasing compliance profile; IH, increasing turning into horizontal compliance profile; D, merely decreasing compliance profile; HD, horizontal turning into decreasing compliance profile; IHD, increasing turning into horizontal and further turning into decreasing compliance profile If compliance profile is I, the PEEP is low. On the other hand, compliance profile is D, PEEP level is considered to be high.	During general anesthesia (up to about 50 min-1 hr after induction of anesthesia)
Secondary	Respiratory compliance	ml cmH2O-1	During general anesthesia (up to about 50 min-1 hr after induction of anesthesia)
Secondary	Driving pressure	cmH2O	During general anesthesia (up to about 50 min-1 hr after induction of anesthesia)
Secondary	Blood pressure	mmHg	During general anesthesia (up to about 50 min-1 hr after induction of anesthesia)