NCT05275283

Brief Summary

The aim of this study is to determine whether application of positive end-expiratory pressure (PEEP) improves respiratory data including respiratory compliance in children who receive positive pressure ventilation using supraglottic airway device (SAD).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

January 3, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 11, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

March 11, 2022

Status Verified

March 1, 2022

Enrollment Period

2 years

First QC Date

November 29, 2021

Last Update Submit

March 1, 2022

Conditions

Positive End Expiratory Pressure

Outcome Measures

Primary Outcomes (1)

  • Respiratory system compliance

    total lung and chest wall compliance, ml/cmH2O

    at the end of surgery, about 2 hours after starting of mechanical ventilation

Secondary Outcomes (5)

  • Respiratory system compliance

    10 minutes, 30 minutes, 60 minutes after starting of mechanical ventilation

  • oropharyngeal leak pressure

    immediate after SAD insertion

  • Electrical impedance tomography parameter - dynamic compliance

    throughout anesthesia (about during 1-3 hours)

  • Electrical impedance tomography parameter - regional ventilation delay

    throughout anesthesia (about during 1-3 hours)

  • Electrical impedance tomography parameter - pulmonary opening pressure

    throughout anesthesia (about during 1-3 hours)

Study Arms (2)

Control group

NO INTERVENTION

Applying tidal volume 7 ml/kg without PEEP

PEEP group

EXPERIMENTAL

Applying tidal volume 7 ml/kg with 6 cmH2O of PEEP

Other: PEEP

Interventions

PEEPOTHER

6 cmH2O of PEEP

PEEP group

Eligibility Criteria

AgeUp to 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Pediatric patients under 6 years of age who are scheduled simple operation under general anesthesia
  • SAD was used for mechanical ventilation

You may not qualify if:

  • Abdominal distension, risk of pulmonary aspiration
  • Bronchopulmonary dysplasia/respiratory distress syndrome
  • Pneumothorax
  • Airway surgery
  • Thoracic surgery or laparotomy
  • Surgery under prone position

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hee-Soo Kim

Seoul, 03080, South Korea

RECRUITING

Central Study Contacts

Hee-Soo Kim, MD, PhD

CONTACT

02-2072-3659dami0605@snu.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 29, 2021

First Posted

March 11, 2022

Study Start

January 3, 2022

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

March 11, 2022

Record last verified: 2022-03

Locations

KR(1)