NCT05726877

Brief Summary

This study aimed to investigate the differences in positive end-expiratory pressure titration in the supine and prone positions by age in pediatric patients under 17 years of age who received general anesthesia and then evaluate the hemodynamic stability.

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
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 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

Study Start

First participant enrolled

October 17, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 14, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

February 14, 2023

Status Verified

January 1, 2023

Enrollment Period

1.2 years

First QC Date

January 6, 2023

Last Update Submit

February 3, 2023

Conditions

Ventilation Therapy; Complications

Outcome Measures

Primary Outcomes (2)

  • Optimal positive end-expiratory pressure (PEEP)

    result of decremental PEEP trial

    10 minutes after intubation

  • Optimal positive end-expiratory pressure (PEEP)

    result of decremental PEEP trial

    60 minutes after prone positioning

Secondary Outcomes (21)

  • Impedance tidal variation

    10 minutes after intubation

  • Impedance tidal variation

    60 minutes after prone positioning

  • regional respiratory system compliance

    60 minutes after prone positioning

  • regional respiratory system compliance

    10 minutes after intubation

  • overdistension or atelectasis

    10 minutes after intubation

  • +16 more secondary outcomes

Study Arms (1)

Experimental arm

EXPERIMENTAL

All patients will be enrolled in the same arm.

Other: ventilation strategy

Interventions

ventilation strategyOTHER

Titrating positive end-expiratory pressure

Experimental arm

Eligibility Criteria

Age0 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • patients who are scheduled to undergo general anesthesia in the prone position
  • patients who are in age under 17 years

You may not qualify if:

  • had cyanosis or chronic respiratory failure
  • had respiratory distress syndrome or bronchopulmonary dysplasia
  • had laryngotracheal diseases
  • had pulmonary hypertension
  • receiving oxygen therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Study Officials

  • Hee-Soo Kim, MD.Ph.D.

    Professor

    STUDY CHAIR

Central Study Contacts

Hee-Soo Kim, M.D., Ph.D.

CONTACT

02-2072-3664dami0605@snu.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2023

First Posted

February 14, 2023

Study Start

October 17, 2022

Primary Completion

December 31, 2023

Study Completion

August 31, 2024

Last Updated

February 14, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)