Back to resultsDriving Pressure-guided PEEP Titration in Robot-assisted Laparoscopic Surgeries
Primary Purpose
Atelectasis, Postoperative Pulmonary
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Titrated PEEP based on driving pressure
Conventional PEEP
Sponsored by
About this trial
This is an interventional prevention trial for Atelectasis, Postoperative Pulmonary focused on measuring Driving pressure, Positive end-expiratory pressure, Lung ultrasound
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing robot-assisted laparoscopic prostatectomy with Trendelenburg position
Exclusion Criteria:
- American Society of Anesthesiologists physical status IV or more
- Severe cardiovascular disease
- Severe chronic obstructive pulmonary disease, emphysema
- History of pneumothorax, bullae
- History of lung resection surgery
- Conversion to laparotomy
- Refusal to participate
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Driving pressure
Conventional
Arm Description
The selected PEEP which makes the driving pressure lowest is applied during the operation.
Conventional PEEP (5cmH2O) is applied.
Outcomes
Primary Outcome Measures
Modified lung ultrasound score
The score is calculated by adding up the 12 individual part scores assessed using lung ultrasound. The score for each part ranges from 0 to 3.
Secondary Outcome Measures
Modified lung ultrasound score
The score is calculated by adding up the 12 individual part scores assessed using lung ultrasound. The score for each part ranges from 0 to 3.
Incidence of intraoperative desaturation
Oxygen saturation by pulse oximetry< 95%
Intraoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Postoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Postoperative pulmonary complications
Extubation failure, Fever, respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, aspiration pneumonitis, pneumonia
Full Information
NCT ID
NCT04327193
First Posted
March 26, 2020
Last Updated
October 14, 2021
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04327193
Brief Title
Driving Pressure-guided PEEP Titration in Robot-assisted Laparoscopic Surgeries
Official Title
The Effectiveness of Driving Pressure Based Ventilation Strategy in Robot-assisted Laparoscopic Surgeries With Steep Trendelenburg Position: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 4, 2020 (Actual)
Primary Completion Date
October 6, 2020 (Actual)
Study Completion Date
October 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to investigate the effect of driving-pressure guided positive end-expiratory pressure (PEEP) titration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atelectasis, Postoperative Pulmonary
Keywords
Driving pressure, Positive end-expiratory pressure, Lung ultrasound
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Driving pressure
Arm Type
Experimental
Arm Description
The selected PEEP which makes the driving pressure lowest is applied during the operation.
Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
Conventional PEEP (5cmH2O) is applied.
Intervention Type
Procedure
Intervention Name(s)
Titrated PEEP based on driving pressure
Intervention Description
Alveolar recruitment and PEEP titration is performed at three time points: after intubation, after Trendelenburg, and after supine after CO2 deflation. The level of PEEP which makes the driving pressure lowest is selected and applied during the operation.
Intervention Type
Procedure
Intervention Name(s)
Conventional PEEP
Intervention Description
Alveolar recruitment is performed at three time points: after intubation, after Trendelenburg, and after supine after CO2 deflation. Conventional PEEP (5cmH2O) is applied during the operation.
Primary Outcome Measure Information:
Title
Modified lung ultrasound score
Description
The score is calculated by adding up the 12 individual part scores assessed using lung ultrasound. The score for each part ranges from 0 to 3.
Time Frame
30 minutes after PACU administration
Secondary Outcome Measure Information:
Title
Modified lung ultrasound score
Description
The score is calculated by adding up the 12 individual part scores assessed using lung ultrasound. The score for each part ranges from 0 to 3.
Time Frame
Intraoperative (at the end of operation before emergence)
Title
Incidence of intraoperative desaturation
Description
Oxygen saturation by pulse oximetry< 95%
Time Frame
Intraoperative
Title
Intraoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Description
Partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Time Frame
Intraoperative (30 minutes after designated PEEP applied)
Title
Postoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Description
Partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Time Frame
30 minutes after PACU administration
Title
Postoperative pulmonary complications
Description
Extubation failure, Fever, respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, aspiration pneumonitis, pneumonia
Time Frame
After operation~ postoperative day 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing robot-assisted laparoscopic prostatectomy with Trendelenburg position
Exclusion Criteria:
American Society of Anesthesiologists physical status IV or more
Severe cardiovascular disease
Severe chronic obstructive pulmonary disease, emphysema
History of pneumothorax, bullae
History of lung resection surgery
Conversion to laparotomy
Refusal to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susie Yoon, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Jongnogu
ZIP/Postal Code
03080
Country
Korea, Republic of
12. IPD Sharing Statement
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Driving Pressure-guided PEEP Titration in Robot-assisted Laparoscopic Surgeries
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