The Association Between Sensory Block Level, Oxygen Therapy, and ORi in Varicose Vein Patients Undergoing Spinal Anesthesia (ORi: Oxygen Reserve Index)

NCT06566690 | Completed

• 1 other identifier: 2024-KAEK-02
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The assessment of peripheral capillary oxygen saturation (SpO2) by pulse oximetry has become standard in perioperative care for the detection of hypoxaemia. The oxygen reserve index (ORI) can provide an early warning of deteriorating oxygenation long before a change in SpO2 occurs, reflect the response to oxygen administration, facilitate oxygen titration and prevent unwanted hyperoxia. The combination of ORI with pulse oximetry can help to accurately adjust inhaled oxygen concentration and prevent hypo- and hyperoxaemia. In spinal anaesthesia, neuraxial blockade can cause paralysis of accessory respiratory muscles and theoretically lead to bronchospasm. Therefore, in this study, the investigators planned to perform oxygen saturation monitoring using two modalities. The investigators wanted to investigate the correlation between ORI, SpO2, oxygen therapy and the degree of sensory block.

Conditions

Hyperoxia; Hypoxia

Keywords

hyperoxia; hypoxia; oxygen therapy; spinal anaesthesia

Outcome Measures

Primary Outcomes (1)

• The primary outcome of this study is to assess the correlation between the need for oxygen therapy, the ascension of sensory block level, and changes in Oxygen Reserve Index (ORi).

  The primary outcome measure of this study is to evaluate the potential correlation between three variables: the need for supplemental oxygen therapy, the cephalad progression of sensory block level, and fluctuations in oxygen reserve index (ORi) values.

  9 months

Interventions

Addition of ORi monitoring to SpO2 monitoring DEVICE

Integration of Oxygen Reserve Index (ORi) monitoring into standard SpO2 monitoring

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study aims to include ASA I-II patients aged 18-65 years scheduled for elective varicose vein surgery, with the sample size to be determined by a pilot study

You may qualify if:

• \- ASA I-II

You may not qualify if:

• Chronic Obstructive Pulmonary Disease (COPD)
• Smoking history of \>30 pack-years
• Cancer patients
• Interstitial lung disease patients
• Patients with Body Mass Index (BMI) \>30 kg/m²
• Patient refusal of spinal anesthesia
• Refusal to participate in the study

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University

Kocaeli, Turkey (Türkiye)

Location

Related Publications (1)

• Scheeren TWL, Belda FJ, Perel A. The oxygen reserve index (ORI): a new tool to monitor oxygen therapy. J Clin Monit Comput. 2018 Jun;32(3):379-389. doi: 10.1007/s10877-017-0049-4. Epub 2017 Aug 8.

  PMID: 28791567 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Hyperoxia; Hypoxia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asist. Prof. M.D

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 22, 2024
• Study Start: August 29, 2024
• Primary Completion: February 10, 2026
• Study Completion: March 6, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

TU (1)