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Clinical Trials/NCT05770583
NCT05770583
Completed
Not Applicable

Determination of the Incidence of Hyperoxia and the Effectiveness of FiO2 Titration Guided by the Oxygen Reserve Index in Preventing Hyperoxia.

Tepecik Training and Research Hospital1 site in 1 country62 target enrollmentSeptember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hyperoxia
Sponsor
Tepecik Training and Research Hospital
Enrollment
62
Locations
1
Primary Endpoint
Correlation of FiO2 and ORi value
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Oxygen therapy is the most common treatment modality for patients with hypoxemia, but target values for normoxemia are not clearly defined. Therefore, iatrogenic hyperoxemia is a very common situation. Even though there are many side effects reported related to hyperoxemia and hyperoxemia is shown to be related to worse outcome than expected; clinicians still observe hyperoxemia frequently.

Oxygen reserve index (ORi™) (Masimo Corp., Irvine, USA) can guide clinicians in detection of hyperoxia. ORi is a parameter which can evaluate partial pressure of oxygen (PaO2) rating from 0 to 1. There are growing evidences in ORi that it might be helpful to reduce hyperoxia in general anesthesia. Continuous ORi monitoring can be used for detecting and preventing hyperoxia. The ability to perform FiO2 titration with ORi may be an appropriate monitoring management to prevent the harmful effects of hyperoxia.In this study, in patients who underwent major abdominal surgery; It was aimed to investigate the effectiveness of ORi-guided FiO2 titration in preventing hyperoxia.

Registry
clinicaltrials.gov
Start Date
September 1, 2020
End Date
March 5, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Tepecik Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Aykut Saritas

associated professor

Tepecik Training and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients older than 18,
  • Patients scheduled for major abdominal surgery that are expected to last longer than 2 hours
  • Patients that have invasive arterial monitorization
  • American Society of Anesthesiologists physical class I, II or III.

Exclusion Criteria

  • Patients younger than 18
  • Patients that need to be treated with high doses of vasopressors,
  • Patients having peripheric hypoperfusion,
  • Hemodynamically unstable patients,
  • Patients with hemoglobinopathy,
  • Morbid obesity (bmi\>40 kg/m2),
  • Patients with arrythmia that can result in hemodynamic instability, patients with acute coronary syndrome
  • Acute respiratory failure or ARDS.

Outcomes

Primary Outcomes

Correlation of FiO2 and ORi value

Time Frame: Until the surgery is over

Correlation of FiO2 value and ORi value. FiO2 adjusted until ORi reaches to zero and %95\<oxygen saturation≤%98

Correlation of PaO2 and ORİ value

Time Frame: Until surgery is over

Pressure of arterial oxygen is obtain from arterial blood gas analysis as usual practice in 10 min and every hour until surgery is over

Secondary Outcomes

  • Heart rate (HR)(First 10 th min after intubation and every hour until surgery is over)
  • Diastolic blood pressure (DBP)(First 10 th min after intubation and every hour until surgery is over)
  • Positive end-expiratory pressure (PEEP)(First 10 th min after intubation and every hour until surgery is over)
  • Systolic blood pressure (SBP)(First 10 th min after intubation and every hour until surgery is over)
  • Fraction of inspired oxygen (FiO2)(First 10 th min after intubation and every hour until surgery is over)

Study Sites (1)

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