Recruitment Maneuver Using Lung Ultrasound in Trauma Patients
Primary Purpose
Recruitment, Trauma
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ultrasound
Sponsored by
About this trial
This is an interventional supportive care trial for Recruitment focused on measuring recruitment, ultrasound, trauma, pulmonary contusion
Eligibility Criteria
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
Sites / Locations
- Ajou university school of medicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
sono group
control group
Arm Description
Evaluate the participant's lung condition using ultrasound and do recruitment maneuver if it is necessary
If participants need recruitment maneuver (decreasing saturation, peak airway pressure > 35 mmHg) by clinical judgement, do recruitment maneuver not using lung ultrasound
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04008758
First Posted
July 2, 2019
Last Updated
March 3, 2023
Sponsor
Ajou University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04008758
Brief Title
Recruitment Maneuver Using Lung Ultrasound in Trauma Patients
Official Title
Evaluation of Efficacy of Recruitment Maneuver Using Lung Ultrasound in Trauma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recruitment, Trauma
Keywords
recruitment, ultrasound, trauma, pulmonary contusion
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized prospective trial
st group is sono group using lung ultrasound
nd group is control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
sono group
Arm Type
Experimental
Arm Description
Evaluate the participant's lung condition using ultrasound and do recruitment maneuver if it is necessary
Arm Title
control group
Arm Type
No Intervention
Arm Description
If participants need recruitment maneuver (decreasing saturation, peak airway pressure > 35 mmHg) by clinical judgement, do recruitment maneuver not using lung ultrasound
Intervention Type
Diagnostic Test
Intervention Name(s)
Ultrasound
Intervention Description
Evaluate participant's lung condition using ultrasound. Using lung ultrasound scoring, more than 1 point needs recruitment maneuver
Primary Outcome Measure Information:
Title
arterial oxygen partial pressure / fractional inspired oxygen ratio at end of surgery
Description
= 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
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Lung ultrasound score
Description
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
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
In Kyong Yi, MD
Phone
+82-219-7522
Email
lyrin01@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hyemin Sohn, MD
Phone
+82-219-7521
Email
sfsohn@aumc.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In Kyong Yi, MD
Organizational Affiliation
Ajou University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ajou university school of medicine
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
In Kyong Yi, MD
Phone
+82-10-3012-6972
Email
lyrin01@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Recruitment Maneuver Using Lung Ultrasound in Trauma Patients
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