NCT06013189

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
103mo left

Started Aug 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress25%
Aug 2023Nov 2034

Study Start

First participant enrolled

August 7, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 28, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
11 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2034

Expected
Last Updated

August 28, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

August 16, 2023

Last Update Submit

August 24, 2023

Conditions

Optimal Sweep Gas FlowDetermination of Optimal Sweep Gas Flow for Different Phases of Cardiopulmonary Bypass

Keywords

sweep gas flowrewarmingcardiopulmonary bypassalkalosis

Outcome Measures

Primary Outcomes (1)

  • Arterial pH lever lower than 7.30

    maintaining physiological pH

    during the cardiopulmonary bypass and postoperative 24th hour

Secondary Outcomes (1)

  • rSO2 20% below initial value

    during the cardiopulmonary bypass

Study Arms (3)

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

Group 3

Sweep Gas Flow decreased during rewarming (1 L/m2/min)

Other: Gas Flow Adjustment

Interventions

Gas Flow AdjustmentOTHER

Decreased gas flow causes PaCO2 to elevate and prevents alkalosis

Group 2Group 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients over 18 years of age scheduled for elective CPB surgery

You may qualify if:

  • Patients over 18 years of age
  • Elective CPB surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acıbadem Altunizade Hastanesi İstanbul

Istanbul, Altunizade, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Alkalosis

Condition Hierarchy (Ancestors)

Acid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Melis Tosun, MD

CONTACT

00905356694002melistosun@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 16, 2023

First Posted

August 28, 2023

Study Start

August 7, 2023

Primary Completion

November 1, 2023

Study Completion (Estimated)

November 1, 2034

Last Updated

August 28, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)