The Role of Perioperative Ventilation (Gas Exchange) During Intrabdominal Surgery on Cognitive Function (ACDYS)
Primary Purpose
Response to Hyperoxia, Hypocapnia
Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
mechanical ventilation
Sponsored by
About this trial
This is an interventional prevention trial for Response to Hyperoxia focused on measuring cognitive dysfunction, mechanical ventilation, hyperoxia, hypocapnia
Eligibility Criteria
Inclusion Criteria:
- Informed consent
- Age > 18 years and below 80 yrs
- Elective abdominal endoscopic intervention
Exclusion Criteria:
- Known cerebral disorder, incl. traumatic injury and severe vascular impairment
- Known psychiatric illness
- Severe drug or alcohol abuse
- Resent stroke (during last 6 months)
- Pregnancy
- Within the 30 days prior to this study, either entry into any other randomized therapeutic study of an agent not licensed for the intended use or administration of any other investigational agent for the treatment of ALI. Patients must not participate in such studies for at least 30 days after enrolment into this study.
Sites / Locations
- City hospital # 1 / Northern State Medical University,
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
normoxia and normocapnia
hyperoxia and normocapnia
normoxia and hypocapnia
hyperoxia-hypocapnia
Arm Description
Normoxia PaO2 of 70-140 mm Hg Normocapnia PaCO2 of 35-48 mmHg
Hyperoxia 150-300 mm Hg Normocapnia PaCO2 of 35-48 mmHg
Normoxia PaO2 of 70-140 mm Hg Hypocapnia PaCO2 of 25-35 mmHg
Hyperoxia 150-300 mm Hg Hypocapnia PaCO2 of 25-35 mmHg
Outcomes
Primary Outcome Measures
Cognitive function
Cognitive function will be assessed using Montreal Cognitive Assessment Score (MoCA)
Secondary Outcome Measures
Psychological Changes
Using developed phone query (memory, cognition, anxiety etc.)
Pain perception
Using Visual Analog Score (VAS)
Pain perception
Using Visual Analog Score (VAS)
Full Information
NCT ID
NCT02267031
First Posted
October 2, 2014
Last Updated
September 21, 2016
Sponsor
Northern State Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02267031
Brief Title
The Role of Perioperative Ventilation (Gas Exchange) During Intrabdominal Surgery on Cognitive Function
Acronym
ACDYS
Official Title
The Role of Perioperative Ventilation (Gas Exchange) During Intrabdominal Surgery on Cognitive Function: a Randomized Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northern State Medical University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Abdominal surgery commonly requires perioperative relaxation and therefore controlled mechanical ventilation. However, respiratory support can be associated with minor, yet clinically significant changes in blood gas content. The inadvertent hyperoxia (excessively high oxygen) and/or hypocapnia (excessively low carbon dioxide) can result in transient changes in cerebral blood flow and cognitive impair.
Detailed Description
The moderate hyperventilation resulting in hypocapnia as well as hyperoxia are common features of mechanical ventilation during general anesthesia. While mild hyperventilation is routinely advocated in laparoscopic surgical interventions, increased FiO2 is set to reinforce safety of respiratory support. Hypocapnia may cause disturbances of cerebral blood flow due to narrowing of cerebral vessels and a decrease cerebral blood flow. Hypocapnia is particularly injurious to the brain in premature infants. Factors that may predispose the immature brain to such injury include poorly developed vascular supply to vulnerable areas, antioxidant depletion by excitatory amino acids, and the lipopolysaccharide and cytokine effects that potentiate destruction of white matter. Data from neonates clearly suggest that severe hypocapnia after hyperventilation contribute to adverse neurologic outcomes. The use of high concentrations of oxygen can lead to a number of events such as the formation of harmful free radicals and activation of lipid peroxidation, resulting in secondary brain injury due to hyperoxia, particularly after suffering anoxia of the brain in resuscitated victims of sudden cardiac arrest. It is recommended to use the fraction of oxygen to maintain saturation at the level of 94-98% when performing cardiopulmonary resuscitation (CPR), due to the risk of reperfusion injury. These disturbances of gas exchange, yet transient can interfere in cerebral blood flow and therefore mental functions.
The primary aim of this study was the assessment of the impact of intraoperative gas exchange (hypocapnia, hyperoxia and their combinations) on the state of higher nervous activity
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Response to Hyperoxia, Hypocapnia
Keywords
cognitive dysfunction, mechanical ventilation, hyperoxia, hypocapnia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
normoxia and normocapnia
Arm Type
Active Comparator
Arm Description
Normoxia PaO2 of 70-140 mm Hg Normocapnia PaCO2 of 35-48 mmHg
Arm Title
hyperoxia and normocapnia
Arm Type
Active Comparator
Arm Description
Hyperoxia 150-300 mm Hg Normocapnia PaCO2 of 35-48 mmHg
Arm Title
normoxia and hypocapnia
Arm Type
Active Comparator
Arm Description
Normoxia PaO2 of 70-140 mm Hg Hypocapnia PaCO2 of 25-35 mmHg
Arm Title
hyperoxia-hypocapnia
Arm Type
Active Comparator
Arm Description
Hyperoxia 150-300 mm Hg Hypocapnia PaCO2 of 25-35 mmHg
Intervention Type
Procedure
Intervention Name(s)
mechanical ventilation
Intervention Description
Patients subjected to scheduled laparoscopic cholecystectomy were enrolled to the ongoing prospective study and randomized into four groups: 1) normoxia and normocapnia (nO2-nCO2), 2) hyperoxia and normocapnia (hO2-nCO2), 3) normoxia and hypocapnia (nO2-lCO2), and 4) hyperoxia-hypocapnia (hO2-lCO2).
Normoxia PaO2 was referred to PaO2 of 70-140 mm Hg, hyperoxia 150-300 mm Hg, normocapnia PaCO2 of 35-48 mmHg and hypocapnia PaCO2 of 25-35 mmHg.
Primary Outcome Measure Information:
Title
Cognitive function
Description
Cognitive function will be assessed using Montreal Cognitive Assessment Score (MoCA)
Time Frame
36 hrs
Secondary Outcome Measure Information:
Title
Psychological Changes
Description
Using developed phone query (memory, cognition, anxiety etc.)
Time Frame
6 months
Title
Pain perception
Description
Using Visual Analog Score (VAS)
Time Frame
6 hrs
Title
Pain perception
Description
Using Visual Analog Score (VAS)
Time Frame
36 hrs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed consent
Age > 18 years and below 80 yrs
Elective abdominal endoscopic intervention
Exclusion Criteria:
Known cerebral disorder, incl. traumatic injury and severe vascular impairment
Known psychiatric illness
Severe drug or alcohol abuse
Resent stroke (during last 6 months)
Pregnancy
Within the 30 days prior to this study, either entry into any other randomized therapeutic study of an agent not licensed for the intended use or administration of any other investigational agent for the treatment of ALI. Patients must not participate in such studies for at least 30 days after enrolment into this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikhail Y. Kirov, MD, PhD
Organizational Affiliation
Northern State Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
City hospital # 1 / Northern State Medical University,
City
Arkhangelsk
ZIP/Postal Code
163001
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
The Role of Perioperative Ventilation (Gas Exchange) During Intrabdominal Surgery on Cognitive Function
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