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Hyperoxia vs Normoxia During Cardiopulmonary Bypass

NCT07510672 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2026-04-03

No results posted yet for this study

Summary

This single-center randomized controlled pilot trial evaluates the effects of intraoperative hyperoxia compared with normoxia during cardiopulmonary bypass (CPB) in adult patients undergoing elective cardiac surgery. The primary aim is to assess the impact on postoperative renal function. Secondary outcomes include inflammatory markers, cardiovascular and pulmonary complications, resource utilization, and short-term mortality.

Conditions

  • AKI
  • Renal Replacement Therapy
  • NGAL
  • Arrythmia
  • Mechanical Ventilation
  • Tracheostomy
  • Mechanical Circulatory Support
  • ICU Length of Stay
  • Hospital Length of Stay
  • Mortality
  • Surgical Complication
  • Cardiac Surgery

Interventions

OTHER

Hyperoxia group

After endotracheal intubation, FiO₂ was maintained at 0.8 and subsequently adjusted to achieve PaO₂ above 300 mmHg. During CPB, air and oxygen flows through the oxygenator were titrated to maintain a target PaO₂ greater than 300 mmHg.

OTHER

Normoxia group (control)

After endotracheal intubation, FiO₂ was initially set to 0.3 and subsequently adjusted to maintain PaO₂ between 70 and 150 mmHg. During CPB, air and oxygen flows through the oxygenator were titrated to maintain a target PaO₂ between 70 and 150 mmHg.

Sponsors & Collaborators

  • University of Padova

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2025-09-15
Completion
2025-10-15

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07510672 on ClinicalTrials.gov