The Effect of Ventilation Modes on Cerebral Oxymetry In Operation

Mechanical Ventilation Pressure High Clinical Trial

Official title:

The Effect of Pressure Controlled and Volume Controlled Ventilation Modes on Cerebral Oxymetry and Blood Gases In Laparoscopic Cholecystectomy Operations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04723043
• Other study ID #: 1305
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: June 25, 2021

Study information

• Verified date: October 2021
• Source: Sisli Hamidiye Etfal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 25, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystitis; Gallstone
• Gallstones
• Intra-Abdominal Hypertension
• Intraabdominal Hypertension
• Mechanical Ventilation Pressure High

Intervention

Device:
• mechanical ventilation modes
ventilation with pressure controlled mode in laparoscopic abdominal surgery ventilation with volume controlled mode in laparoscopic abdominal surgery

Locations

Country	Name	City	State
Turkey	Sisli Etfal Research and Training Hospital	Sisli	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sisli Hamidiye Etfal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. Erratum in: Anesth Analg. 2006 Jun;102(6):1645. Fierro, Giovanni [corrected to Fierro, Giuseppe]. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NIRS	near infrared reflectance spectroscopy values recorded at before the anesthesia, after intubation, before and after deflation	0 to 3 hours (approximately)
Primary	oxygen saturation	oxygen saturation with pulse-oximeter at before the anesthesia, after intubation, before and after deflation	0 to 3 hours (approximately)
Primary	end-tidal carbon dioxide	end-tidal carbon dioxide with mechanical ventilator at before the anesthesia, after intubation, before and after deflation	0 to 3 hours (approximately)
Secondary	partial oxygen pressure	partial oxygen pressure in blood gases at before the anesthesia, after intubation, before and after deflation	0 to 3 hours (approximately)
Secondary	P peak	peak pressure in mechanical ventilation mod at before the anesthesia, after intubation, before and after deflation	0 to 3 hours (approximately)