NCT04008758

Brief Summary

In trauma patients, the incidence of pulmonary contusion is frequent. Recruit maneuver using lung ultrasound could be improve oxygenation in trauma populatioin, howevere, there is no previous study. The aim of this study is evaluation of the efficacy of lung recruitment using ultrasound in perioperative period in trauma patients.

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
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Longer than P75 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
27 days until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 6, 2023

Status Verified

March 1, 2023

Enrollment Period

4.4 years

First QC Date

July 2, 2019

Last Update Submit

March 3, 2023

Conditions

Keywords

recruitmentultrasoundtraumapulmonary contusion

Outcome Measures

Primary Outcomes (1)

  • arterial oxygen partial pressure / fractional inspired oxygen ratio at end of surgery

    = P /F ratio; Smaller value respresents poor outcome Using arterial blood gas analysis the difference between baseline (immediate after intubation) and end of surgery : If P/F ratio difference is improved compared to baseline, it means recruitment maneuver is effective

    2 hours

Secondary Outcomes (1)

  • Lung ultrasound score

    2 hours

Study Arms (2)

sono group

EXPERIMENTAL

Evaluate the participant's lung condition using ultrasound and do recruitment maneuver if it is necessary

Diagnostic Test: Ultrasound

control group

NO INTERVENTION

If participants need recruitment maneuver (decreasing saturation, peak airway pressure \> 35 mmHg) by clinical judgement, do recruitment maneuver not using lung ultrasound

Interventions

UltrasoundDIAGNOSTIC_TEST

Evaluate participant's lung condition using ultrasound. Using lung ultrasound scoring, more than 1 point needs recruitment maneuver

sono group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Who need surgery under general anesthesia due to trauma
  • The position of the surgery is supine

You may not qualify if:

  • Who has been ventilator care before the surgery
  • Thoracic surgery
  • Who had cardiopulmonary resuscitation
  • Who has acute respiratory distress syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou university school of medicine

Suwon, Gyeonggi-do, 16499, South Korea

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • In Kyong Yi, MD

    Ajou University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

In Kyong Yi, MD

CONTACT

Hyemin Sohn, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized prospective trial 1. st group is sono group using lung ultrasound 2. nd group is control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

July 2, 2019

First Posted

July 5, 2019

Study Start

August 1, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

March 6, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations