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  • Status : Approved
    • First Submitted Date : 2017/11/29
    • Registered Date : 2018/02/09
    • Last Updated Date : 2018/01/04
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1. Background

Background Information
CRIS
Registration Number
KCT0002688 
Unique Protocol ID 학술15-033 
Public/Brief Title A comparison of ventilation mode undergoing laparoscopic cholecystectomy 
Scientific Title In patients undergoing laparoscopic cholecystectomy, measure changes in peak airway pressure and tidal volume according to ventilation  
Acronym  
MFDS Regulated Study Yes
IND/IDE Protocol  
Registered
at Other Registry
No
Healthcare Benefit
Approval Status
 

2. Institutional Review Board/Ethics Committee

Institutional Review Board Information
Board Approval Status Submitted approval 
Board Approval Number 학술15-033 
Approval Date 2015-06-23 
Institutional Review Board  
Name College of medicine, Inha university hospital IRB 
Address  
Telephone  
Data Monitoring Committee No  

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Jang Ho Song 
Title professor 
Telephone +82-32-890-3968 
Affiliation Inha University Hospital 
Address inha unversity hospital,Jung Gu, In Cheon 
Contact Person for Public Queries
Name Seung Won Ryu 
Title resident 
Telephone +82-32-890-3945 
Affiliation Inha University Hospital 
Address inha unversity hospital,Jung Gu, In Cheon 
Contact Person for Updating Information
Name Seung Won Ryu 
Title resident 
Telephone +82-32-890-3945 
Affiliation Inha University Hospital 
Address inha unversity hospital,Jung Gu, In Cheon 

4. Status

Status Information
Study Site Single
Overall Recruitment Status Completed  
Date of First Enrollment 2015-07-01 , Actual
Target Number of Participant 36
Primary Completion Date 2015-09-30 , Actual
Study Completion Date 2015-09-30 , Actual
Recruitment Status by Participating Study Site 1
Name of Study Site Inha University Hospital 
Recruitment Status Completed  
Date of First Enrollment 2015-07-01 , Actual

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Inha University Hospital 
Organization Type Medical Institute  
Project ID  

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
Organization Name Inha University Hospital 
Organization Type Medical Institute  

7. Study Summary

Study Summary Information
Lay Summary During laparoscopic surgery, changes in abdominal pressure, lung resistance and compliance may lead to changes in airway pressure and functional residual capacity.
We hypothesized that pressure controlled ventilation-volume guaranteed mode would maintain adequate tidal volume with reducing airway pressure, as compared with volume controlled ventilation.
We performed laparoscopic cholecystectomy under general anesthesia in healthy adult. Volume controlled ventilation group and pressure controlled ventilation-volume guaranteed group were divided into 18 patients.  

8. Study Design

Study Design Information
Study Type Observational Study 
Observational Study Model Case-control 
Time Perspective Prospective  
Target Number of Participant 36
Cohort/Group Number
Cohort/
Group 1
Cohort/Group
Label
volume controlled ventilation group 
Cohort/Group
Description
Set ventilation volume to 8 ml/kg of actual body weight, set breath rate to 12 times/minute, FiO2 to 0.3, PEEP not applied, and inspiration and expiration ratio to 1: 2 to keep EtCO2 at 35-40 mmHg. If EtCO2 is greater than 40, increase the respiratory rate by 2 in increments of 5 minutes to 18 times/minute. If not maintained, and the tidal volume is increased by 1 ml/kg every 5 minutes intervals to 12 ml/kg. If EtCO2 is less than 35mmHg, the respiratory rate is reduced by 2 at 5 minute intervals up to 8 times/minute. If not maintained, the tidal volume is decreased by 1 ml/kg at 5 minute intervals to 6 ml/Kg. Observe airway pressure and tidal volume during the laparoscopic surgery. 
Biospecimen
Collection & Archiving
Not collect nor Archive 
Biospecimen Description  
Cohort/
Group 2
Cohort/Group
Label
pressure controlled ventilation-volume guaranteed 
Cohort/Group
Description
Set ventilation volume to 8 ml/kg of actual body weight, set breath rate to 12 times/minute, FiO2 to 0.3, PEEP not applied, and inspiration and expiration ratio to 1: 2 to keep EtCO2 at 35-40 mmHg. If EtCO2 is greater than 40, increase the respiratory rate by 2 in increments of 5 minutes to 18 times/minute. If not maintained, and the tidal volume is increased by 1 ml/kg every 5 minutes intervals to 12 ml/kg. If EtCO2 is less than 35mmHg, the respiratory rate is reduced by 2 at 5 minute intervals up to 8 times/minute. If not maintained, the tidal volume is decreased by 1 ml/kg at 5 minute intervals to 6 ml/Kg. Observe airway pressure and tidal volume during the laparoscopic surgery. 
Biospecimen
Collection & Archiving
Not collect nor Archive 
Biospecimen Description  

9. Subject Eligibility

Subject Eligibility Information
Study Population Description Young healthy adult male  
Sampling Method Randomization was performed in each group using simple randomization  
Condition(s)/Problem(s) * Diseases of the digestive system
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 20 Year ~ 55 Year
Description Age from 20 to 55 years
Patients with a BMI less than 30
Patients with ASA class 1 or 2.
Patients undergoing laparoscopic cholecystectomy under general anesthesia.
 
Exclusion Criteria Patients over 30 BMI
Patients expected to have difficulty in tracheal intubation
Patients with asthma, chronic obstructive pulmonary disease or patients with interstitial lung disease
Patients with heart disease
Patients who were switched to open surgery during surgery
The peak airway pressure is above 30 or the oxygen saturation is below 95 during surgery
Patients who refused to participate in the study  
Healthy Volunteers  

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome /Safety/Efficacy 
Primary Outcome(s) 1 
Outcome peak airway pressure 
Timepoint 15 minutes after intubation, 15 minutes, 30 minutes after CO2 insufflation 
Primary Outcome(s) 2 
Outcome tidal volume 
Timepoint 15 minutes after intubation, 15 minutes, 30 minutes after CO2 insufflation 
Secondary Outcome(s) 1 
Outcome PaO2, 
Timepoint 15 minutes after intubation, 15 minutes, 30 minutes after CO2 insufflation 
Secondary Outcome(s) 2 
Outcome PaCO2 
Timepoint 15 minutes after intubation, 15 minutes, 30 minutes after CO2 insufflation 
Secondary Outcome(s) 3 
Outcome Blood pressure 
Timepoint 15 minutes after intubation, 15 minutes, 30 minutes after CO2 insufflation 

11. Study Results and Publication

Study Results and Publication Information
Result Registerd  

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

Sharing of Study Data Information
Sharing Statement Not provided at time of Registration 
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