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

NCT ID: NCT05770583

Last Updated: 2023-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2023-03-05

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Control group

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

Group Type: ACTIVE_COMPARATOR

SpO2 (oxygen saturation)

Intervention Type: PROCEDURE

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

ORi+SpO2 (oxygen saturation) group

• 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

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Interventions

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

• 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

Intervention Type: PROCEDURE

SpO2 (oxygen saturation)

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

Intervention Type: PROCEDURE

Other Intervention Names

ORİ+SpO2

Eligibility Criteria

Inclusion Criteria

1. Patients older than 18,

2. Patients scheduled for major abdominal surgery that are expected to last longer than 2 hours

3. Patients that have invasive arterial monitorization

4. American Society of Anesthesiologists physical class I, II or III.

Exclusion Criteria

1. Patients younger than 18

2. Patients that need to be treated with high doses of vasopressors,

3. Patients having peripheric hypoperfusion,

4. Hemodynamically unstable patients,

5. Patients with hemoglobinopathy,

6. Pregnancy,

7. Morbid obesity (bmi>40 kg/m2),

8. Patients with arrythmia that can result in hemodynamic instability, patients with acute coronary syndrome

9. Acute respiratory failure or ARDS.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tepecik Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Aykut Saritas

associated professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tepecik Research and Training Hospital

Izmir, Konak, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 32454913 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21994818 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30138170 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31227971 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29445905 (View on PubMed)

Other Identifiers

Tepecik Training and research

Identifier Type: -

Identifier Source: org_study_id