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

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.

Study Overview

• Status: Completed
• Conditions: Uterine Myoma; Ovarian Cyst; Laparoscopic Gynecologic Surgery
• Intervention / Treatment: Procedure: conventional I:E ratio; Procedure: 1:1 ratio; Procedure: 2:1 group; Procedure: external PEEP

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Seoul Hospital, Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
arterial O2 partial pressure	arterial O2 partial pressure	10 min after induction, 30 and 60 min after start of pneumoperitoneum
Mean airway pressure	Mean airway pressure	10 min after induction, 30 and 60 min after start of pneumoperitoneum
tidal volume (setting)	tidal volume (setting)	10 min after induction, 30 and 60 min after start of pneumoperitoneum
hemodynamic parameters	systolic/ diastolic blood pressure, heart rate, mean blood pressure	10 min after induction, 30 and 60 min after start of pneumoperitoneum
end-tidal CO2 partial pressure	end-tidal CO2 partial pressure	10 min after induction, 30 and 60 min after start of pneumoperitoneum
respiratory compliance	Dynamic compliance, Static compliance	10 min after induction, 30 and 60 min after start of pneumoperitoneum
Dead space	physiologic dead space / tidal volume (VD/VT)	10 min after induction, 30 and 60 min after start of pneumoperitoneum
work of breathing	work of breathing	10 min after induction, 30 and 60 min after start of pneumoperitoneum
peak inspiratory pressure	peak inspiratory pressure	10 min after induction, 30 and 60 min after start of pneumoperitoneum
plateau pressure	plateau pressure	10 min after induction, 30 and 60 min after start of pneumoperitoneum
positive end-expiratory pressure	positive end-expiratory pressure	10 min after induction, 30 and 60 min after start of pneumoperitoneum
tidal volume (exhaled)	tidal volume (exhaled)	10 min after induction, 30 and 60 min after start of pneumoperitoneum
minute ventilation	minute ventilation	10 min after induction, 30 and 60 min after start of pneumoperitoneum

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Study Director: Tae Soo Hahm, M.D.,Ph.D., Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: June 21, 2011
• First Submitted That Met QC Criteria: June 22, 2011
• First Posted (Estimate): June 23, 2011

Study Record Updates

• Last Update Posted (Estimate): October 1, 2012
• Last Update Submitted That Met QC Criteria: September 27, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: laparoscopic gynecologic surgery; gas exchange; inspiratory time; expiratory time; I:E ratio
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Endocrine System Diseases; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma; Ovarian Cysts
• Other Study ID Numbers: 2011-04-007