The Effectiveness of FiO2 Titration Guided by the Oxygen Reserve Index in Preventing Hyperoxia.

NCT05770583 | Completed DMC

• 1 other identifier: Tepecik Training and research
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperoxia; Complication

Outcome Measures

Primary Outcomes (2)

• Correlation of FiO2 and ORi value

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

  Until the surgery is over

• Correlation of PaO2 and ORİ value

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

  Until surgery is over

Secondary Outcomes (5)

• Fraction of inspired oxygen (FiO2)

  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

• Diastolic blood pressure (DBP)

  First 10 th min after intubation and every hour until surgery is over

• Heart rate (HR)

  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

Study Arms (2)

Control group

ACTIVE COMPARATOR

Fraction of inspired oxygen (FiO2) is titrated guided by oxygen saturation in that range; %95\<oxygen saturation≤%98

Procedure: SpO2 (oxygen saturation)

ORi+SpO2 (oxygen saturation) group

EXPERIMENTAL

* FiO2 will be titrated by reducing 10% if Ori\>0.01 andSpO2 ≥ 98% until Ori is 0.00. * FiO2 will not be changed if Ori is 0.00 and %95\<oxygen saturation≤%98 * FiO2 will be increased by 10% if oxygen saturation \<95 or PaO2\<60 mmHg

Procedure: Titration of fraction of inspired oxygen (FiO2) guided by ORI and oxygen saturation

Interventions

Titration of fraction of inspired oxygen (FiO2) guided by ORI and oxygen saturation PROCEDURE

* FiO2 will be titrated by reducing 10% if Ori\>0.01 and oxygen saturation ≥ 98% until Ori is 0.00. * FiO2 will not be changed if Ori is 0.00 and %95\<oxygen saturation≤%98 * FiO2 will be increased by 10% if oxygen saturation \<95 or PaO2\<60 mmHg

Also known as: ORİ+SpO2

ORi+SpO2 (oxygen saturation) group

SpO2 (oxygen saturation) PROCEDURE

Fraction of inspired oxygen (FiO2) is titrated guided by oxygen saturation in that range; %95\<oxygen saturation≤%98

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• Pregnancy,
• 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.

Sponsors & Collaborators

• Tepecik Training and Research Hospital: lead

Study Sites (1)

Tepecik Research and Training Hospital

Izmir, Konak, 35110, Turkey (Türkiye)

Location

Related Publications (5)

• Pala Cifci S, Urcan Tapan Y, Turemis Erkul B, Savran Y, Comert B. The Impact of Hyperoxia on Outcome of Patients Treated with Noninvasive Respiratory Support. Can Respir J. 2020 May 6;2020:3953280. doi: 10.1155/2020/3953280. eCollection 2020.

  PMID: 32454913 BACKGROUND

• Mach WJ, Thimmesch AR, Pierce JT, Pierce JD. Consequences of hyperoxia and the toxicity of oxygen in the lung. Nurs Res Pract. 2011;2011:260482. doi: 10.1155/2011/260482. Epub 2011 Jun 5.

  PMID: 21994818 BACKGROUND

• Vos JJ, Willems CH, van Amsterdam K, van den Berg JP, Spanjersberg R, Struys MMRF, Scheeren TWL. Oxygen Reserve Index: Validation of a New Variable. Anesth Analg. 2019 Aug;129(2):409-415. doi: 10.1213/ANE.0000000000003706.

  PMID: 30138170 BACKGROUND

• Yoshida K, Isosu T, Noji Y, Ebana H, Honda J, Sanbe N, Obara S, Murakawa M. Adjustment of oxygen reserve index (ORi) to avoid excessive hyperoxia during general anesthesia. J Clin Monit Comput. 2020 Jun;34(3):509-514. doi: 10.1007/s10877-019-00341-9. Epub 2019 Jun 22.

  PMID: 31227971 BACKGROUND

• Scheeren TWL, Belda FJ, Perel A. Correction to: The oxygen reserve index (ORI): a new tool to monitor oxygen therapy. J Clin Monit Comput. 2018 Jun;32(3):579-580. doi: 10.1007/s10877-018-0104-9.

  PMID: 29445905 BACKGROUND

MeSH Terms

Conditions

Hyperoxia

Interventions

Oxygen Saturation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metabolism

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associated professor

Study Record Dates

• First Submitted: March 5, 2023
• First Posted: March 15, 2023
• Study Start: September 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: March 5, 2023
• Last Updated: March 16, 2023

Record last verified: 2023-03

Locations

TU (1)