Viewing Study NCT02267031



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Study NCT ID: NCT02267031
Status: COMPLETED
Last Update Posted: 2016-09-22
First Post: 2014-10-02

Brief Title: The Role of Perioperative Ventilation Gas Exchange During Intrabdominal Surgery on Cognitive Function
Sponsor: Northern State Medical University
Organization: Northern State Medical University

Study Overview

Official Title: The Role of Perioperative Ventilation Gas Exchange During Intrabdominal Surgery on Cognitive Function a Randomized Clinical Study
Status: COMPLETED
Status Verified Date: 2016-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ACDYS
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 andor 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None