The Effect of Different I:E Ratio on Gas Exchange of Patients Undergoing Gynecologic Laparoscopic Surgery With Trendelenburg Position

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tae Soo Hahm, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01379313
First received: June 21, 2011
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Uterine Myoma
Ovarian Cyst
Laparoscopic Gynecologic Surgery
Procedure: conventional I:E ratio
Procedure: 1:1 ratio
Procedure: 2:1 group
Procedure: external PEEP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: The Effect of Different I:E Ratio on Gas Exchange of Patients Undergoing Gynecologic Laparoscopic Surgery With Trendelenburg Position

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • arterial CO2 partial pressure [ Time Frame: 10 minutes after induction of general anesthesia ] [ Designated as safety issue: No ]
    arteial CO2 partial pressure

  • arterial CO2 partial pressure [ Time Frame: 30 minutes after start of pneumoperitoneum ] [ Designated as safety issue: No ]
    arteial CO2 partial pressure

  • arterial CO2 partial pressure [ Time Frame: 60 minutes after start of pneumoperitoneum ] [ Designated as safety issue: No ]
    arteial CO2 partial pressure


Secondary Outcome Measures:
  • arterial O2 partial pressure [ Time Frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum ] [ Designated as safety issue: No ]
    arterial O2 partial pressure

  • Mean airway pressure [ Time Frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum ] [ Designated as safety issue: No ]
    Mean airway pressure

  • tidal volume (setting) [ Time Frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum ] [ Designated as safety issue: No ]
    tidal volume (setting)

  • hemodynamic parameters [ Time Frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum ] [ Designated as safety issue: Yes ]
    systolic/ diastolic blood pressure, heart rate, mean blood pressure

  • end-tidal CO2 partial pressure [ Time Frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum ] [ Designated as safety issue: No ]
    end-tidal CO2 partial pressure

  • respiratory compliance [ Time Frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum ] [ Designated as safety issue: No ]
    Dynamic compliance, Static compliance

  • Dead space [ Time Frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum ] [ Designated as safety issue: No ]
    physiologic dead space / tidal volume (VD/VT)

  • work of breathing [ Time Frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum ] [ Designated as safety issue: No ]
    work of breathing

  • peak inspiratory pressure [ Time Frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum ] [ Designated as safety issue: No ]
    peak inspiratory pressure

  • plateau pressure [ Time Frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum ] [ Designated as safety issue: No ]
    plateau pressure

  • positive end-expiratory pressure [ Time Frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum ] [ Designated as safety issue: No ]
    positive end-expiratory pressure

  • tidal volume (exhaled) [ Time Frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum ] [ Designated as safety issue: No ]
    tidal volume (exhaled)

  • minute ventilation [ Time Frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum ] [ Designated as safety issue: No ]
    minute ventilation


Enrollment: 100
Study Start Date: June 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1:2 group
conventional I:E ratio group, inspiratory time : expiratory time = 1:1
Procedure: conventional I:E ratio
conventional I:E ratio of 1:2 is applied.
Experimental: 1:1 group
1:1 I:E ratio group, inspiratory time : expiratory time = 1:1
Procedure: 1:1 ratio
I:E ratio of 1:1 is applied.
Experimental: 2:1 group
inverse ratio group, inspiratory time : expiratory time = 2:1
Procedure: 2:1 group
Inverse I:E ratio of 2:1 is applied.
Active Comparator: 1:2 PEEP group
I:E ratio of 1:2 with external PEEP of 5 cm H2O
Procedure: conventional I:E ratio
conventional I:E ratio of 1:2 is applied.
Procedure: external PEEP
external positive end-expiratory pressure of 5 cmH2O is applied.

Detailed Description:

In patients undergoing gynecologic laparoscopic surgery with trendelenburg position, the disturbance of pulmonary gas exchange frequently occurs due to high intra-abdominal pressure. During the laparoscopic surgery with abdominal gas insufflation, gas exchange disturbance such as CO2 retention, hypoxemia occurs in addition to high plateau airway pressure. The usual strategy against these kinds of problem is pressure-controlled ventilation. However, the gas exchange problem especially CO2 retention can not be solved in some cases. The inverse-ratio ventilation (IRV), which prolongs the inspiratory time greater than expiratory time, can be applied for adult respiratory distress syndrome. The efficacy of IRV is to improve gas-exchange status by increasing mean airway pressure and alveolar recruitment. There have been several clinical investigations which applied IRV during general anesthesia. However, there have been debates about the effect of IRV during general anesthesia. Therefore, we tried to apply the IRV for subjects undergoing laparoscopic surgery, and evaluate the effect of different I:E ratio on the pulmonary gas exchange and respiratory mechanics.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01379313

Locations
Korea, Republic of
Samsung Seoul Hospital, Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Study Director: Tae Soo Hahm, M.D.,Ph.D. Samsung Medical Center
Principal Investigator: Won Ho Kim, M.D. Samsung Medical Center
  More Information

No publications provided

Responsible Party: Tae Soo Hahm, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01379313     History of Changes
Other Study ID Numbers: 2011-04-007
Study First Received: June 21, 2011
Last Updated: September 27, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
laparoscopic gynecologic surgery
gas exchange
inspiratory time
expiratory time
I:E ratio

Additional relevant MeSH terms:
Ovarian Cysts
Cysts
Ovarian Diseases
Leiomyoma
Myofibroma
Adnexal Diseases
Connective Tissue Diseases
Endocrine System Diseases
Genital Diseases, Female
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neoplasms, Connective Tissue
Neoplasms, Muscle Tissue

ClinicalTrials.gov processed this record on October 20, 2014