NCT02340741

Brief Summary

Effect of intraoperative insufflation of carbon dioxide on the neurologic complications in the early postoperative period after open cardiac surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
334

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

March 22, 2016

Status Verified

March 1, 2016

Enrollment Period

3 years

First QC Date

December 16, 2014

Last Update Submit

March 19, 2016

Conditions

Air EmbolismNeurological Damage

Keywords

carbon dioxidepostoperative cerebrovascular complicationsair embolism

Outcome Measures

Primary Outcomes (1)

  • postoperative neurological disorders (stroke, psychosis,encephalopathy), as measured by Confusion Assessment Method for the ICU, Richmond Agitation-Sedation Scale, Standardized Mini-Mental State Examination

    conducting tests: Confusion Assessment Method for the ICU, Richmond Agitation-Sedation Scale, Standardized Mini-Mental State Examination

    14 days

Secondary Outcomes (1)

  • hospital mortality

    14 days

Study Arms (2)

conventional prophylaxis of aeroembolism

OTHER

Procedure: cardiac surgery with opening of heart chambers. Will be including 167 patients to undergo cardiac surgery. After the main operation phase all heart cavities are sealed, left vent drainage is stopped, ascending aorta is punctured and cardiac massage is performed, ventilation is started and the heart is filled with volume. Operating table is positioned in the Trendelenburg position, and aorta is opened. The amount of air in the cavities is evaluated by transesophageal echocardiography.

Procedure: conventional prophylaxis of aeroembolismProcedure: cardiac surgery with opening of heart chambers

conventional prophylaxis plus CO2 insufflation

OTHER

Procedure: cardiac surgery with opening of heart chambers. Will be including 167 patients to undergo cardiac surgery. After the main phase of the operation standard measures of aeroembolism prevention are carried out. The amount of air in the cavities is evaluated by transesophageal echocardiography.

Procedure: conventional prophylaxis plus CO2 insufflationProcedure: cardiac surgery with opening of heart chambers

Interventions

conventional prophylaxis of aeroembolismPROCEDURE

167 patients will be enrolled. Will perform standard way of aeroembolism prevention

conventional prophylaxis of aeroembolism
conventional prophylaxis plus CO2 insufflationPROCEDURE

167 patients will be enrolled. Will perform standard way of aeroembolism prevention and insufflation of carbon dioxide

conventional prophylaxis plus CO2 insufflation
cardiac surgery with opening of heart chambersPROCEDURE

Patients with different clinical diagnoses, which is planned to cardiac surgery with the opening heart cavities

conventional prophylaxis of aeroembolismconventional prophylaxis plus CO2 insufflation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to sign Informed Consent and Release of Medical Information forms
  • Age 18 - 70 years
  • Patients scheduled on cardiac surgery with opening cavities

You may not qualify if:

  • History of stroke and TIA
  • Significant carotid artery stenosis
  • Presence of initial severe encephalopathy
  • Re-clamping of the aorta
  • Emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novosibirsk State Research Institute of Circulation Pathology

Novosibirsk, Novosibirsk Territory, 630055, Russia

RECRUITING

MeSH Terms

Conditions

Embolism, AirTrauma, Nervous System

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

EmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesNervous System DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Aleksandr V Bogachev-Prokophiev, PhD

    Meshalkin Research Institute of Pathology of Circulation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2014

First Posted

January 19, 2015

Study Start

September 1, 2014

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

March 22, 2016

Record last verified: 2016-03

Locations

RU(1)