Clinical trial NCT01379313: The Effect of Different I:E Ratio on Gas Exchange of Patients Undergoing Gynecologic Laparoscopic Surgery With Trendelenburg Position
Official title: The Effect of Different I:E Ratio on Gas Exchange of Patients Undergoing Gynecologic Laparoscopic Surgery With Trendelenburg Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Myoma
Ovarian Cyst
Laparoscopic Gynecologic Surgery
Keywords: laparoscopic gynecologic surgery
gas exchange
inspiratory time
expiratory time
I:E ratio
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-06-23
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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 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.

Primary outcomes:
measure: arterial CO2 partial pressure
timeFrame: 10 minutes after induction of general anesthesia
measure: arterial CO2 partial pressure
timeFrame: 30 minutes after start of pneumoperitoneum
measure: arterial CO2 partial pressure
timeFrame: 60 minutes after start of pneumoperitoneum
Secondary outcomes:
measure: arterial O2 partial pressure
timeFrame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
measure: Mean airway pressure
timeFrame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
measure: tidal volume (setting)
timeFrame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
measure: hemodynamic parameters
timeFrame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
measure: end-tidal CO2 partial pressure
timeFrame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
measure: respiratory compliance
timeFrame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
measure: Dead space
timeFrame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
measure: work of breathing
timeFrame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
measure: peak inspiratory pressure
timeFrame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
measure: plateau pressure
timeFrame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
measure: positive end-expiratory pressure
timeFrame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
measure: tidal volume (exhaled)
timeFrame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
measure: minute ventilation
timeFrame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Seoul Hospital, Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Tae Soo Hahm, M.D.,Ph.D.
role: STUDY_DIRECTOR
affiliation: Samsung Medical Center
name: Won Ho Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References: