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The Effect of Ventilation Modes on Cerebral Oxymetry In Operation

Primary Purpose

Cholecystitis; Gallstone, Mechanical Ventilation Pressure High, Intraabdominal Hypertension

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
mechanical ventilation modes
Sponsored by
Sisli Hamidiye Etfal Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cholecystitis; Gallstone focused on measuring laparoscopy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sisli Etfal Research and Training Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

v group

p group

Arm Description

patients will ventilate with volume controlled mode

patients will ventilate with pressure controlled mode

Outcomes

Primary Outcome Measures

NIRS
near infrared reflectance spectroscopy values recorded at before the anesthesia, after intubation, before and after deflation
oxygen saturation
oxygen saturation with pulse-oximeter at before the anesthesia, after intubation, before and after deflation
end-tidal carbon dioxide
end-tidal carbon dioxide with mechanical ventilator at before the anesthesia, after intubation, before and after deflation

Secondary Outcome Measures

partial oxygen pressure
partial oxygen pressure in blood gases at before the anesthesia, after intubation, before and after deflation
P peak
peak pressure in mechanical ventilation mod at before the anesthesia, after intubation, before and after deflation

Full Information

First Posted
January 20, 2021
Last Updated
October 13, 2021
Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04723043
Brief Title
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

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sisli Hamidiye Etfal Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis; Gallstone, Mechanical Ventilation Pressure High, Intraabdominal Hypertension
Keywords
laparoscopy

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
v group
Arm Type
Active Comparator
Arm Description
patients will ventilate with volume controlled mode
Arm Title
p group
Arm Type
Active Comparator
Arm Description
patients will ventilate with pressure controlled mode
Intervention Type
Device
Intervention Name(s)
mechanical ventilation modes
Intervention Description
ventilation with pressure controlled mode in laparoscopic abdominal surgery ventilation with volume controlled mode in laparoscopic abdominal surgery
Primary Outcome Measure Information:
Title
NIRS
Description
near infrared reflectance spectroscopy values recorded at before the anesthesia, after intubation, before and after deflation
Time Frame
0 to 3 hours (approximately)
Title
oxygen saturation
Description
oxygen saturation with pulse-oximeter at before the anesthesia, after intubation, before and after deflation
Time Frame
0 to 3 hours (approximately)
Title
end-tidal carbon dioxide
Description
end-tidal carbon dioxide with mechanical ventilator at before the anesthesia, after intubation, before and after deflation
Time Frame
0 to 3 hours (approximately)
Secondary Outcome Measure Information:
Title
partial oxygen pressure
Description
partial oxygen pressure in blood gases at before the anesthesia, after intubation, before and after deflation
Time Frame
0 to 3 hours (approximately)
Title
P peak
Description
peak pressure in mechanical ventilation mod at before the anesthesia, after intubation, before and after deflation
Time Frame
0 to 3 hours (approximately)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ayse surhan cinar
Organizational Affiliation
chief of anesthesia department
Official's Role
Study Director
Facility Information:
Facility Name
Sisli Etfal Research and Training Hospital
City
Şişli
State/Province
Istanbul
ZIP/Postal Code
34371
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21170237
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.
Results Reference
background
PubMed Identifier
16115985
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. Erratum In: Anesth Analg. 2006 Jun;102(6):1645. Fierro, Giovanni [corrected to Fierro, Giuseppe].
Results Reference
background
PubMed Identifier
24672486
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.
Results Reference
background

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The Effect of Ventilation Modes on Cerebral Oxymetry In Operation

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