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

Uterine Myoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01379313
• Other study ID #: 2011-04-007
• Status: Completed
• Phase: N/A
• First received: June 21, 2011
• Last updated: September 27, 2012
• Start date: June 2011
• Est. completion date: March 2012

Study information

• Verified date: September 2012
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Laparoscopic Gynecologic Surgery
• Leiomyoma
• Ovarian Cyst
• Ovarian Cysts
• Uterine Myoma

Intervention

Procedure:
• conventional I:E ratio
conventional I:E ratio of 1:2 is applied.
• 1:1 ratio
I:E ratio of 1:1 is applied.
• 2:1 group
Inverse I:E ratio of 2:1 is applied.
• external PEEP
external positive end-expiratory pressure of 5 cmH2O is applied.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Seoul Hospital, Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	arterial CO2 partial pressure	arteial CO2 partial pressure	10 minutes after induction of general anesthesia	No
Primary	arterial CO2 partial pressure	arteial CO2 partial pressure	30 minutes after start of pneumoperitoneum	No
Primary	arterial CO2 partial pressure	arteial CO2 partial pressure	60 minutes after start of pneumoperitoneum	No
Secondary	arterial O2 partial pressure	arterial O2 partial pressure	10 min after induction, 30 and 60 min after start of pneumoperitoneum	No
Secondary	Mean airway pressure	Mean airway pressure	10 min after induction, 30 and 60 min after start of pneumoperitoneum	No
Secondary	tidal volume (setting)	tidal volume (setting)	10 min after induction, 30 and 60 min after start of pneumoperitoneum	No
Secondary	hemodynamic parameters	systolic/ diastolic blood pressure, heart rate, mean blood pressure	10 min after induction, 30 and 60 min after start of pneumoperitoneum	Yes
Secondary	end-tidal CO2 partial pressure	end-tidal CO2 partial pressure	10 min after induction, 30 and 60 min after start of pneumoperitoneum	No
Secondary	respiratory compliance	Dynamic compliance, Static compliance	10 min after induction, 30 and 60 min after start of pneumoperitoneum	No
Secondary	Dead space	physiologic dead space / tidal volume (VD/VT)	10 min after induction, 30 and 60 min after start of pneumoperitoneum	No
Secondary	work of breathing	work of breathing	10 min after induction, 30 and 60 min after start of pneumoperitoneum	No
Secondary	peak inspiratory pressure	peak inspiratory pressure	10 min after induction, 30 and 60 min after start of pneumoperitoneum	No
Secondary	plateau pressure	plateau pressure	10 min after induction, 30 and 60 min after start of pneumoperitoneum	No
Secondary	positive end-expiratory pressure	positive end-expiratory pressure	10 min after induction, 30 and 60 min after start of pneumoperitoneum	No
Secondary	tidal volume (exhaled)	tidal volume (exhaled)	10 min after induction, 30 and 60 min after start of pneumoperitoneum	No
Secondary	minute ventilation	minute ventilation	10 min after induction, 30 and 60 min after start of pneumoperitoneum	No