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

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:

MedlinePlus related topics: Gas Ovarian Cysts

U.S. FDA Resources

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

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
Myoma
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type
Neoplasms
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 23, 2013