Recruitment Maneuver Using Lung Ultrasound in Trauma Patients

Evaluation of Efficacy of Recruitment Maneuver Using Lung Ultrasound in Trauma Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Trauma; Recruitment
• Intervention / Treatment: Diagnostic test: Ultrasound

Detailed Description

In trauma patients, the incidence of pulmonary contusion is 17-75%. Pulmonary contusioin leads to atelectasis, lung consolidatioin. Finally it could results acute respiratory distress syndrome.

Lung ultrasound is non-invasive and available in anytime even during surgery. Previous studies showed recruitment maneuver using ultrasound improved postoperative oxygenation in pediatric cardiac surgery. In adults, recruitment maneuver not using ultrasound improved oxygenation after cardiopulmonary bypass. There is no study in adult trauma population.

The aim of this study is evaluation of the efficacy of lung recruitment using ultrasound in perioperative period in trauma patients.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: In Kyong Yi, MD; Phone Number: +82-219-7522; Email: lyrin01@gmail.com
• Study Contact Backup: Name: Hyemin Sohn, MD; Phone Number: +82-219-7521; Email: sfsohn@aumc.ac.kr

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Suwon, Gyeonggi-do, Korea, Republic of, 16499
      • Recruiting
      • Ajou University School of Medicine
      • Contact: In Kyong Yi, MD; Phone Number: +82-10-3012-6972; Email: lyrin01@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sono group; Evaluate the participant's lung condition using ultrasound and do recruitment maneuver if it is necessary	Diagnostic test: Ultrasound; Evaluate participant's lung condition using ultrasound. Using lung ultrasound scoring, more than 1 point needs recruitment maneuver
No Intervention: control group; If participants need recruitment maneuver (decreasing saturation, peak airway pressure > 35 mmHg) by clinical judgement, do recruitment maneuver not using lung ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung ultrasound score	Using lung ultrasound, evaluate lung condition in both group at end of surgery Scoring using "lung ultrasound scoring" Scoring range: 0, normal; 1, small loss of aeration; 2, moderate loss of aeration; 4, severe loss of aeration	2 hours

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: July 2, 2019
• First Submitted That Met QC Criteria: July 2, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: trauma; ultrasound; recruitment; pulmonary contusion
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: AJIRB-MED-OBS-19-119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No