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Assessment of perioperative atelectasis by lung ultrasonography in patients undergoing abdominal surgery: comparison of conventional versus protective ventilation

Status Approved

First Submitted Date

2019/04/08
Registered Date

2019/04/12
Last Updated Date

2020/07/13

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0003746
Unique Protocol ID	EUMC 2018-07-087-001
Public/Brief Title	Assessment of perioperative atelectasis by lung ultrasonography in patients undergoing abdominal surgery: comparison of conventional versus protective ventilation
Scientific Title	Assessment of perioperative atelectasis by lung ultrasonography in patients undergoing abdominal surgery: comparison of conventional versus protective ventilation
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	EUMC 2018-07-087-001
Approval Date	2018-09-21
Institutional Review Board Name	institutional review board of Ewha Womans Hospital
Institutional Review Board Address	1071, Anyangcheon-ro, Yangcheon-gu, Seoul
Institutional Review Board Telephone	02-2650-5872
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	JAE HEE WOO
Title	Assistant Professor
Telephone	+82-2-6986-4959
Affiliation	Ewha Womans University Medical Center
Address	260, Gonghang-daero, Gangseo-gu, Seoul, 07804, Korea
Contact Person for Public Queries
Name	JAE HEE WOO
Title	Assistant Professor
Telephone	+82-2-6986-4959
Affiliation	Ewha Womans University Medical Center
Address	260, Gonghang-daero, Gangseo-gu, Seoul, 07804, Korea
Contact Person for Updating Information
Name	JAE HEE WOO
Title	Assistant Professor
Telephone	+82-2-6986-4959
Affiliation	Ewha Womans University Medical Center
Address	260, Gonghang-daero, Gangseo-gu, Seoul, 07804, Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2018-10-22 Actual
Target Number of Participant	42
Primary Completion Date	2019-08-13 , Actual
Study Completion Date	2019-11-30 , Actual
Name of Study	Ewha Womans University Medical Center
Recruitment Status	Completed
Date of First Enrollment	2018-10-22 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Ewha Womans University Medical Center
Organization Type	Medical Institute
Project ID
2. Source of Monetary/Material Support
Organization Name	Ministry of Science and ICT
Organization Type	Government
Project ID	NRF-2017R1C1B5018202

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Ewha Womans University Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	The purpose of this study was to evaluate lung ultrasound (LUS) score to determine the effect of protective closure technique on the incidence of atelectasis in patients undergoing abdominal surgery. In a retrospective analysis of 11,000 non-cardiac anesthesia during surgery, hypoxia is defined as a ratio of arterial oxygen partial pressure (PaO2) to oxygen fraction (FiO2) of less than 300, and approximately 50% of patients with general anesthesia develop hypoxia. Hypoxia, which occurs during general anesthesia, is caused by the shunt of pulmonary blood flow due to atelectasis. After abdominal surgery, diaphragmatic dysfunction is associated with atelectasis, pulmonary collapse or pneumonia, which may lead to longer hospital stay and increased medical costs. Several studies have shown that lung ultrasound is useful for tracking respiratory complications in patients undergoing surgery. Protective ventilation is commonly used in patients under general anesthesia. The purpose of this study was to evaluate the effect of protective ventilation on the incidence of atelectasis using lung ultrasound.

Study Summary Information

Lay Summary

The purpose of this study was to evaluate lung ultrasound (LUS) score to determine the effect of protective closure technique on the incidence of atelectasis in patients undergoing abdominal surgery.
In a retrospective analysis of 11,000 non-cardiac anesthesia during surgery, hypoxia is defined as a ratio of arterial oxygen partial pressure (PaO2) to oxygen fraction (FiO2) of less than 300, and approximately 50&#37; of patients with general anesthesia develop hypoxia. Hypoxia, which occurs during general anesthesia, is caused by the shunt of pulmonary blood flow due to atelectasis. After abdominal surgery, diaphragmatic dysfunction is associated with atelectasis, pulmonary collapse or pneumonia, which may lead to longer hospital stay and increased medical costs. Several studies have shown that lung ultrasound is useful for tracking respiratory complications in patients undergoing surgery. Protective ventilation is commonly used in patients under general anesthesia. The purpose of this study was to evaluate the effect of protective ventilation on the incidence of atelectasis using lung ultrasound.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Diagnosis
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator, Caregiver
Allocation	RCT
Intervention Type	/Procedure/Surgery
Intervention Description	Patients are divided into groups that receive a traditional or protective ventilation by randomization. For patients receiving conventional ventilation, a tidal volume of 9-10 ml / kg predicted body weight is used with no PEEP. In patients using the protective ventilation, a tidal volume of 6 - 8 ml / kg predicted body weight and PEEP 5 mmHg will be applied after induction of anesthesia. Lung ultrasound is performed at each of the following time points; before the induction of anesthesia, 5 minute after the mechanical ventilation, and at the end of the operation and in the recovery room. All ultrasound examinations are performed by the same anesthesiologist who has more than 100 pulmonary ultrasound scan experience. We analyzed the pulmonary ultrasound scores according to the time of both groups.
Number of Arms	2
Arm 1	Arm Label conventional ventilation
	Target Number of Participant 21
	Arm Type Active comparator
	Arm Description For patients receiving conventional ventilation, a tidal volume of 9-10 ml / kg predicted body weight is used with no PEEP.
Arm 2	Arm Label protective ventilation
	Target Number of Participant 21
	Arm Type Experimental
	Arm Description In patients using the protective ventilation, a tidal volume of 6-8 ml / kg predicted body weight and PEEP 5 mmHg will be applied after induction of anesthesia.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (J00-J99)Diseases of the respiratory system (J98.10)Atelectasis patients undergoing abdominal surgery under general anesthesia
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~No Limit
	Description 19 or older with American Society of Anesthesiologists (ASA) physical status I to III, who were scheduled for open abdominal surgery with an expected duration of more than 2 h
Exclusion Criteria	(BMI)> 40 kg / m 2, American College of Anesthesiologists physical status IV or V, history of thoracic surgery including chest tube, severe obstructive pulmonary disease, difficult to cooperate, nervous system disease, diaphragmatic paralysis, a history of mechanical ventilation within a month preceding surgery
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	LUS (lung ultrasound score) score
Timepoint	Immediately before induction of anesthesia, 5 minutes after induction of anesthesia,After the operation,Recovery room
Secondary Outcome(s) 1
Outcome	arterial blood gas analysis
Timepoint	Immediately before induction of anesthesia, 5 minutes after induction of anesthesia,After the operation,Recovery room

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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