NCT04753554

Brief Summary

In our study, we aimed to observe the usability of non-invasive monitoring methods in oxygenation management, using non-invasive monitoring techniques, preventing hyperoxia and avoiding oxidative damage-related complications in patients undergoing on-pump cardiac surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 15, 2021

Completed
Last Updated

February 15, 2021

Status Verified

February 1, 2021

Enrollment Period

4 months

First QC Date

February 11, 2021

Last Update Submit

February 11, 2021

Conditions

HyperoxiaOxygen Reserve IndexCardiac Surgery

Keywords

hyperoxiaORI

Outcome Measures

Primary Outcomes (3)

  • Oxygen saturation

    This will be measured preoperatively; routinely 4 times perioperatively, if there is any intervention after the intervention; and 3 times postoperatively. Reported as % (T1: Preoperative, T2: after intubation, T3: aortic cross clemp o, T4: aortic cross clemp off, T5: After decanullation; T6: 2 hours after operation; T7: After extubation; T8: 24 hours after operation)

    24 hours

  • Parsial oxygen pressure

    This will be measured preoperatively by blood gas analysis; routinely 4 times perioperatively, if there is any intervention after the intervention; and 3 times postoperatively. Reported as mmHg. (T1: Preoperative, T2: after intubation, T3: aortic cross clemp o, T4: aortic cross clemp off, T5: After decanullation; T6: 2 hours after operation; T7: After extubation; T8: 24 hours after operation)

    24 hours

  • Oxygen reserve index

    This will be measured only in ORI group patients using Masimo device preoperatively; routinely 4 times perioperatively and if there is any intervention after the intervention. (T1: Preoperative, T2: after intubation, T3: aortic cross clemp o, T4: aortic cross clemp off, T5: After decanullation)

    6 hours

Secondary Outcomes (5)

  • Lactate levels

    24 hours

  • Near-infrared Spectroscopy values (Left/Right)

    24 hours

  • Urine & Creatinine & ALT & AST

    24 hours

  • Lung Ultrasound Scores

    24 hours

  • CAM-ICU

    24 hours

Study Arms (2)

Conventional group

ACTIVE COMPARATOR

The patient group that whose oxygenation will be managed by blood gas analysis.

Device: ORI groupOther: Conventional group

ORI group

EXPERIMENTAL

The patient group that whose oxygenation will be managed by ORI values

Device: ORI group

Interventions

ORI groupDEVICE

The patient group whose oxygenation will be managed by ORI values. Hyperoxia or hypoxia will be prevented by using also blood gas analysis in critically ill patients.

Conventional groupORI group
Conventional groupOTHER

In this patient group oxygenation will be managed as usual, using blood gas analysis.

Conventional group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between the ages of 18 - 75
  • Patients undergoing on-pump cardiac surgery

You may not qualify if:

  • Patients with advanced CHF (EF \<40%)
  • Patients with advanced COPD (FEV1 \<60%)
  • Patients with a history of CVD
  • Patients with advanced carotid lesions (\> 50-70% of stenosis)
  • Patients with renal failure
  • Patients with liver failure
  • Patients with cardiac arrhythmia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Istanbul, Bakirkoy / Istanbul, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hyperoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist, MD

Study Record Dates

First Submitted

February 11, 2021

First Posted

February 15, 2021

Study Start

July 1, 2020

Primary Completion

October 15, 2020

Study Completion

October 15, 2020

Last Updated

February 15, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)