Recruitment Maneuver Using Lung Ultrasound in Trauma Patients

Sponsor
Ajou University School of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT04008758
Collaborator
(none)
70
1
2
41
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Ultrasound
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized prospective trial st group is sono group using lung ultrasound nd group is control groupRandomized prospective trial st group is sono group using lung ultrasound nd group is control group
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Evaluation of Efficacy of Recruitment Maneuver Using Lung Ultrasound in Trauma Patients
Actual Study Start Date :
Aug 1, 2019
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. arterial oxygen partial pressure / fractional inspired oxygen ratio at end of surgery [2 hours]

    = 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

Secondary Outcome Measures

  1. Lung ultrasound score [2 hours]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ajou university school of medicine Suwon Gyeonggi-do Korea, Republic of 16499

Sponsors and Collaborators

  • Ajou University School of Medicine

Investigators

  • Principal Investigator: In Kyong Yi, MD, Ajou University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
In-kyong Yi, Clinical assistant professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier:
NCT04008758
Other Study ID Numbers:
  • AJIRB-MED-OBS-19-119
First Posted:
Jul 5, 2019
Last Update Posted:
Feb 18, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by In-kyong Yi, Clinical assistant professor, Ajou University School of Medicine
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 18, 2022