search
Back to results

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
Northern State Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Response to Hyperoxia focused on measuring cognitive dysfunction, mechanical ventilation, hyperoxia, hypocapnia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 2, 2014
Last Updated
September 21, 2016
Sponsor
Northern State Medical University
search

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

We'll reach out to this number within 24 hrs