The Role of Perioperative Ventilation (Gas Exchange) During Intrabdominal Surgery on Cognitive Function (ACDYS)

September 21, 2016 updated by: Northern State Medical University

The Role of Perioperative Ventilation (Gas Exchange) During Intrabdominal Surgery on Cognitive Function: a Randomized Clinical Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
109

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Arkhangelsk, Russian Federation, 163001
        • City hospital # 1 / Northern State Medical University,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: normoxia and normocapnia
Normoxia PaO2 of 70-140 mm Hg Normocapnia PaCO2 of 35-48 mmHg
Procedure: mechanical ventilation

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.
Active Comparator: hyperoxia and normocapnia
Hyperoxia 150-300 mm Hg Normocapnia PaCO2 of 35-48 mmHg
Procedure: mechanical ventilation

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.
Active Comparator: normoxia and hypocapnia
Normoxia PaO2 of 70-140 mm Hg Hypocapnia PaCO2 of 25-35 mmHg
Procedure: mechanical ventilation

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.
Active Comparator: hyperoxia-hypocapnia
Hyperoxia 150-300 mm Hg Hypocapnia PaCO2 of 25-35 mmHg
Procedure: mechanical ventilation

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cognitive function
Time Frame: 36 hrs
Cognitive function will be assessed using Montreal Cognitive Assessment Score (MoCA)
36 hrs

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Psychological Changes
Time Frame: 6 months
Using developed phone query (memory, cognition, anxiety etc.)
6 months
Pain perception
Time Frame: 6 hrs
Using Visual Analog Score (VAS)
6 hrs
Pain perception
Time Frame: 36 hrs
Using Visual Analog Score (VAS)
36 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northern State Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mikhail Y. Kirov, MD, PhD, Northern State Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AC-2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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