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

NCT ID: NCT06566690

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-29

Study Completion Date

2026-03-10

Brief Summary

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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.

Detailed Description

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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. The respiratory effects of neuraxial blockade up to mid-thoracic level are minimal in patients without lung disease. While the intercostal muscles may be paralysed by thoracic block, diaphragmatic function is preserved. 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

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Hyperoxia Hypoxia

Keywords

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hyperoxia hypoxia oxygen therapy spinal anaesthesia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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Addition of ORi monitoring to SpO2 monitoring

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\- ASA I-II

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kocaeli University

OTHER

Sponsor Role lead

Responsible Party

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Volkan Alparslan

Asist. Prof. M.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kocaeli University

Kocaeli, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Volkan Alparslan

Role: CONTACT

Phone: +905059374578

Email: [email protected]

Facility Contacts

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Volkan Alparslan, Md.

Role: primary

References

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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.

Reference Type RESULT
PMID: 28791567 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/28791567/

Related Info

Other Identifiers

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2024-KAEK-02

Identifier Type: -

Identifier Source: org_study_id