Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT04327193
NCT04327193CompletedNot Applicable

The Effectiveness of Driving Pressure Based Ventilation Strategy in Robot-assisted Laparoscopic Surgeries With Steep Trendelenburg Position: a Randomized Controlled Trial

Seoul National University Hospital1 site in 1 country66 target enrollmentStarted: May 4, 2020Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
66
Locations
1
Primary Endpoint
Modified lung ultrasound score
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to investigate the effect of driving-pressure guided positive end-expiratory pressure (PEEP) titration.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Driving pressure

Experimental

The selected PEEP which makes the driving pressure lowest is applied during the operation.

Intervention: Titrated PEEP based on driving pressure (Procedure)

Conventional

Active Comparator

Conventional PEEP (5cmH2O) is applied.

Intervention: Conventional PEEP (Procedure)

Outcomes

Primary Outcomes

Modified lung ultrasound score

Time Frame: 30 minutes after PACU administration

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 Outcomes

  • Postoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio(30 minutes after PACU administration)
  • Intraoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio(Intraoperative (30 minutes after designated PEEP applied))
  • Incidence of intraoperative desaturation(Intraoperative)
  • Modified lung ultrasound score(Intraoperative (at the end of operation before emergence))
  • Postoperative pulmonary complications(After operation~ postoperative day 3)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Susie Yoon

Clinical Assistant Professor

Seoul National University Hospital

Study Sites (1)

Loading locations...

Similar Trials

Completed
Not Applicable
Driving Pressure Guided Ventilation Versus Conventional Lung Protective Strategy in Morbid Obese Patients Undergoing Laparoscopic Bariatric SurgeryDriving Pressure
NCT04861168Tanta University60
Completed
Not Applicable
The Comparison of the Effect of Pressure-controlled Ventilation and Volume-controlled Ventilation on the Gastric Insufflations in I-gelGeneral Anesthesia
NCT02466295Yonsei University68
Completed
Not Applicable
Effects of PEEP on Optic Nerve Sheath Diameter During Robot-Assisted Laparoscopic ProstatectomyOther Surgical Procedures
NCT02516566Asan Medical Center38
Recruiting
Not Applicable
Driving Pressure-guided Lung Protective VentilationVentilator LungHypoxemia
NCT06361420Yong Lin, PhD43
Unknown
Not Applicable
Efficacy Evaluation of Positive End-expiratory Pressure in Children Undergoing Mechanical Ventilation Using Supraglottic Airway DevicePositive End Expiratory Pressure
NCT05275283Seoul National University Hospital94