NCT01443962

Brief Summary

During the laparoscopic cholecystectomy, Pneumoperitoneum could affect to the regional oxygen saturation of brain. positive end expiratory pressure (PEEP)could improve the respiratory parameters include oxygenation. So applying PEEP could improve the regional brain oxygen saturation (rSO2)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 30, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

February 5, 2013

Status Verified

February 1, 2013

Enrollment Period

4 months

First QC Date

September 27, 2011

Last Update Submit

February 2, 2013

Conditions

Brain Ischemia

Keywords

laparoscopic cholecystectomyPEEPrSO2

Outcome Measures

Primary Outcomes (1)

  • change in regional brain oxygen saturation

    FiO2 0.6, Tidal vlume 8 ml/IBW (kg), PEEP 10 cm H2O or not, respiratory rate as end-tidal carbone dioxide concentration (ETCO2). During the peumoperitoneum record rSO2 every 10 minutes with respiratory parameters (Peak pressure, mean pressure, PEEP) and vital signs

    from baseline record rSO2 every 10 minutes

Study Arms (2)

Zero positive end expiratory pressure

EXPERIMENTAL

Number: 30, apply no PEEP during the pneumoperitoneum during the laparoscopic cholecystectomy PEEP was not applied whole investigation period

Other: PEEP

positive end expiratory pressure

ACTIVE COMPARATOR

applying PEEP 10 cmH2O during pneumoperitoneum continuously

Other: ZEEP

Interventions

PEEPOTHER

applying PEEP 0 cmH2O during pneumoperitoneum continuously

Also known as: PEEP 0
Zero positive end expiratory pressure
ZEEPOTHER

applying PEEP 10 cmH2O during pneumoperitoneum continuously

Also known as: PEEP 10
positive end expiratory pressure

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I or II,
  • year,
  • patient who undergoing laparoscopic cholecystectomy

You may not qualify if:

  • cerebrovascular disease,
  • coronary artery disease,
  • morbid obesity (BMI \> 30)
  • propofol allergy,
  • addictive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hyun Jeong Kwak

Incheon, South Korea

Location

MeSH Terms

Conditions

Brain Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Kyung Chon Lee, M.D., Ph.D

    Gachon University Gil Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 27, 2011

First Posted

September 30, 2011

Study Start

November 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

February 5, 2013

Record last verified: 2013-02

Locations

KR(1)