NCT01379313

Brief Summary

In patients undergoing gynecologic laparoscopic surgery with trendelenburg position, the disturbance of pulmonary gas exchange frequently occurs due to high intra-abdominal pressure. The investigators tried to evaluate the effect of various inspiratory to expiratory ratio on pulmonary gas exchange by randomized controlled trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 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

Study Start

First participant enrolled

June 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 23, 2011

Completed
8 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

October 1, 2012

Status Verified

September 1, 2012

Enrollment Period

9 months

First QC Date

June 21, 2011

Last Update Submit

September 27, 2012

Conditions

Uterine MyomaOvarian CystLaparoscopic Gynecologic Surgery

Keywords

laparoscopic gynecologic surgerygas exchangeinspiratory timeexpiratory timeI:E ratio

Outcome Measures

Primary Outcomes (3)

  • arterial CO2 partial pressure

    arteial CO2 partial pressure

    10 minutes after induction of general anesthesia

  • arterial CO2 partial pressure

    arteial CO2 partial pressure

    30 minutes after start of pneumoperitoneum

  • arterial CO2 partial pressure

    arteial CO2 partial pressure

    60 minutes after start of pneumoperitoneum

Secondary Outcomes (13)

  • arterial O2 partial pressure

    10 min after induction, 30 and 60 min after start of pneumoperitoneum

  • Mean airway pressure

    10 min after induction, 30 and 60 min after start of pneumoperitoneum

  • tidal volume (setting)

    10 min after induction, 30 and 60 min after start of pneumoperitoneum

  • hemodynamic parameters

    10 min after induction, 30 and 60 min after start of pneumoperitoneum

  • end-tidal CO2 partial pressure

    10 min after induction, 30 and 60 min after start of pneumoperitoneum

  • +8 more secondary outcomes

Study Arms (4)

1:2 group

ACTIVE COMPARATOR

conventional I:E ratio group, inspiratory time : expiratory time = 1:1

Procedure: conventional I:E ratio

1:1 group

EXPERIMENTAL

1:1 I:E ratio group, inspiratory time : expiratory time = 1:1

Procedure: 1:1 ratio

2:1 group

EXPERIMENTAL

inverse ratio group, inspiratory time : expiratory time = 2:1

Procedure: 2:1 group

1:2 PEEP group

ACTIVE COMPARATOR

I:E ratio of 1:2 with external PEEP of 5 cm H2O

Procedure: conventional I:E ratioProcedure: external PEEP

Interventions

conventional I:E ratioPROCEDURE

conventional I:E ratio of 1:2 is applied.

1:2 PEEP group1:2 group
1:1 ratioPROCEDURE

I:E ratio of 1:1 is applied.

1:1 group
2:1 groupPROCEDURE

Inverse I:E ratio of 2:1 is applied.

2:1 group
external PEEPPROCEDURE

external positive end-expiratory pressure of 5 cmH2O is applied.

1:2 PEEP group

Eligibility Criteria

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

You may qualify if:

  • patients undergoing elective gynecologic laparoscopic surgery
  • the duration of pneumoperitoneum during laparoscopic surgery is more than 40 minutes

You may not qualify if:

  • ASA (American society of anesthesiologists) classification of the subjects more than III.
  • Age under 20, or more than 65 years.
  • Past history of pneumothorax, COPD, asthma.
  • Patients with ischemic heart disease, valvular heart disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Seoul Hospital, Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

MyofibromaOvarian Cysts

Interventions

BuspironePopulation Groups

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsConnective Tissue DiseasesSkin and Connective Tissue DiseasesCystsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Spiro CompoundsHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesPolycyclic CompoundsDemographyPopulation Characteristics

Study Officials

  • Tae Soo Hahm, M.D.,Ph.D.

    Samsung Medical Center

    STUDY DIRECTOR

  • Won Ho Kim, M.D.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 21, 2011

First Posted

June 23, 2011

Study Start

June 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

October 1, 2012

Record last verified: 2012-09

Locations

KR(1)