Clinical trial NCT04723043: The Effect of Ventilation Modes on Cerebral Oxymetry In Operation
Official title: The Effect of Pressure Controlled and Volume Controlled Ventilation Modes on Cerebral Oxymetry and Blood Gases In Laparoscopic Cholecystectomy Operations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystitis; Gallstone
Mechanical Ventilation Pressure High
Intraabdominal Hypertension
Keywords: laparoscopy
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The first group was labelled as "Group V" as they are applied with mechanical ventilation under controlled volume, and the second group was labelled as "Group P" as they are applied with mechanical
Primary purpose: SCREENING

Brief summary: In laparoscopic cholecystectomy method, Insufflation of CO2 in abdominal cavity causes positioning of the diaphragm upwards, a decrease in lung's volume and its compliance, an increase in the airway resistance, mismatch between the atelectasis and the ventilation perfusion. Although there are numerous studies in laparoscopic surgery, only a few of them investigate the effects of laparoscopic surgery on the cardiopulmonary and the respiratory mechanics. The investigator aimed To examine the effects of pressure-controlled and volume-controlled ventilation modes on cerebral oximetry and blood gases in laparoscopic cholecystectomy operations.

Detailed description: Since the laparoscopic methods have been introduced to the surgical operations, laparoscopic cholecystectomy has become the golden standard in gall bladder surgical treatments. In this method, carbon dioxide (CO2) pneumoperitoneum method is used to achieve the desired surgical and visual conditions. Alongside the advantages of the Laparoscopic cholecystectomy method (e.g. shortening the patient's length of stay at the hospital, minimal postoperative pain and rapid recovery), it has various intraabdominal pressure related systemic disadvantages . Insufflation of CO2 in abdominal cavity causes positioning of the diaphragm upwards, a decrease in lung's volume and its compliance, an increase in the airway resistance, mismatch between the atelectasis and the ventilation perfusion. Various ventilation strategies have been introduced to increase arterial oxygenation, functional residual capacity (FRC), and the lung compliance. Recent studies; demonstrates that pressure-controlled mechanical ventilation is superior to volume-controlled mechanical ventilation in providing arterial and tissue oxygenation.

Although there are numerous studies in laparoscopic surgery, only a few of them investigate the effects of laparoscopic surgery on the cardiopulmonary and the respiratory mechanics. Several experimental and clinical studies describe that the cardiovascular effects of the high intraabdominal pressure and the CO2 insufflation is complex. In fact, the results are linked to the studied patients' population, the lung's position and its volume. As it is known in laparoscopic surgeries, the oxygenation in cerebral tissue decreases as the intraabdominal pressure increases. At present, bispectral index (BIS), electroencephalography (EEG), auditory evoke potential (AEP) (and several others) and functional NIRS (fNIRS) are used to measure cerebral oxygenation and anaesthetic depth. NIRS monitorisation makes use of the combined effects of the transmission, the reflection, the dispersion, and the absorption of light. It can also measure the oxygen saturation in tissues that does not have pulsatile circulation. The investigator aimed To examine the effects of pressure-controlled and volume-controlled ventilation modes on cerebral oximetry and blood gases in laparoscopic cholecystectomy operations.

Eligibility criteria: Inclusion Criteria:

* ASA (American Society of Anesthesiology) score of 1 and 2
* body mass index \< 30 kg/m2
* planned elective laparoscopic cholecystectomy operation
* 18-65 years old

Exclusion Criteria:

* who are applied with emergency laparoscopic cholecystectomy operation
* ASA (American Society of Anesthesiology) score of 3 and above
* hematocrit value 30 and below
* body mass index\> 30 kg/m2
* major pulmonary disease (this condition was defined as having capacity and currency flow speed values that are below %70 in respiratory functional tests)
* patients with a history of thoracic surgery

Primary outcomes:
measure: NIRS
timeFrame: 0 to 3 hours (approximately)
measure: oxygen saturation
timeFrame: 0 to 3 hours (approximately)
measure: end-tidal carbon dioxide
timeFrame: 0 to 3 hours (approximately)
Secondary outcomes:
measure: partial oxygen pressure
timeFrame: 0 to 3 hours (approximately)
measure: P peak
timeFrame: 0 to 3 hours (approximately)
Other outcomes:
Locations:
city: Şişli
country: Turkey
facility: Sisli Etfal Research and Training Hospital
state: Istanbul
Study officials:
affiliation: chief of anesthesia department
name: ayse surhan cinar
role: STUDY_DIRECTOR
References:
citation: Gipson CL, Johnson GA, Fisher R, Stewart A, Giles G, Johnson JO, Tobias JD. Changes in cerebral oximetry during peritoneal insufflation for laparoscopic procedures. J Minim Access Surg. 2006 Jun;2(2):67-72. doi: 10.4103/0972-9941.26651.
citation: Casati A, Fanelli G, Pietropaoli P, Proietti R, Tufano R, Danelli G, Fierro G, De Cosmo G, Servillo G; Collaborative Italian Study Group on Anesthesia in Elderly Patients. Continuous monitoring of cerebral oxygen saturation in elderly patients undergoing major abdominal surgery minimizes brain exposure to potential hypoxia. Anesth Analg. 2005 Sep;101(3):740-747. doi: 10.1213/01.ane.0000166974.96219.cd.
citation: Nielsen HB. Systematic review of near-infrared spectroscopy determined cerebral oxygenation during non-cardiac surgery. Front Physiol. 2014 Mar 17;5:93. doi: 10.3389/fphys.2014.00093. eCollection 2014.