Re-Adjustment of Sweep Gas Flow to the During the Rewarming Period of the Cardiopulmonary Bypass

Re-Adjustment of Sweep Gas Flow to the During the Rewarming Period of the Cardiopulmonary Bypass to Prevent Alkalosis

The investigators designed this prospective observational study with the theory that alkalosis caused by decreased CO2 solubility due to temperature increase during the rewarming period of the Cardiopulmonary Bypass could be prevented by reducing the sweep gas flow during the rewarming period.

Study Overview

• Status: Recruiting
• Conditions: Optimal Sweep Gas Flow; Determination of Optimal Sweep Gas Flow for Different Phases of Cardiopulmonary Bypass
• Intervention / Treatment: Other: Gas Flow Adjustment

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Melis Tosun, MD; Phone Number: 00905356694002; Email: melistosun@gmail.com

Study Locations

• Turkey
  • Altunizade
    • Istanbul, Altunizade, Turkey
      • Recruiting
      • Acıbadem Altunizade Hastanesi İstanbul
      • Contact: Melis Tosun, MD; Phone Number: 00905356694002; Email: melistosun@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients over 18 years of age scheduled for elective CPB surgery

Description

Inclusion Criteria:

• Patients over 18 years of age
• Elective CPB surgery

Exclusion Criteria:

• Patients undergoing minimally invasive surgery
• Patients undergoing robotic cardiac surgery,
• Patients undergoing deep hypothermia,
• Patients undergoing total circulatory arrest,
• Patients whose FiO2 requirement is high that cannot be applied to target gas flow

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Sweep Gas Flow did not changed (1.35 L/m2/min)
Group 2; Sweep Gas Flow decreased during rewarming (1.2 L/m2/min)	Other: Gas Flow Adjustment; Decreased gas flow causes PaCO2 to elevate and prevents alkalosis
Group 3; Sweep Gas Flow decreased during rewarming (1 L/m2/min)	Other: Gas Flow Adjustment; Decreased gas flow causes PaCO2 to elevate and prevents alkalosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial pH lever lower than 7.30	maintaining physiological pH	during the cardiopulmonary bypass and postoperative 24th hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rSO2 20% below initial value	observing the rSO2 of brain during rewarming period	during the cardiopulmonary bypass

Collaborators and Investigators

• Sponsor: Acıbadem Atunizade Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2023
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): November 1, 2034

Study Registration Dates

• First Submitted: August 16, 2023
• First Submitted That Met QC Criteria: August 24, 2023
• First Posted (Actual): August 28, 2023

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: cardiopulmonary bypass; rewarming; alkalosis; sweep gas flow
• Additional Relevant MeSH Terms: Metabolic Diseases; Acid-Base Imbalance; Alkalosis
• Other Study ID Numbers: ATADEK 2019-19/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No