The Effect of Intraoperative Hyperoxemia on Postoperative Delirium in Geriatric Patients

NCT06326372 | Completed DMC

• 1 other identifier: Delirium
• Study Type: observational
• Target: 114
• 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; Delirium in Old Age

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 ORi and Delirium

  Correlation of ORİ and SpO2 values with delirium measured by CAM and CAM-ICU

  Up to 48 hours

Secondary Outcomes (1)

• Correlation of FiO2 and delirium

  first 10 th minutes after entubation and every 10 minutes until surgery is over

Study Arms (2)

Control group

In the control group, observation will be conducted solely by another anesthesia doctor or assistant participating in the study, and the data will be recorded blindly without being reported to the anesthesia doctor responsible for the surgery. The oxygen therapy administered by the anesthesia doctor in charge and the FiO2 values will be recorded independently and blindly, based solely on the clinician's own assessment, rather than according to the information obtained from ORi. Subsequently, for two days following the surgery, evaluations will be conducted twice daily at the same hours for ward patients using CAM, and for ICU patients using CAM-ICU. If delirium is detected, delirium subtyping will be performed using the Richmond Agitation-Sedation Scale (RASS).

Procedure: control

ORi+SpO2 group

In the SpO2+ORi group; It is aimed to maintain SpO2 between %95 and %98, and ORi at 0.00. Data will be recorded every 10 minutes. After extubation, patients will first be evaluated in the postoperative recovery room. Subsequently, for two days following the surgery, evaluations will be conducted twice daily at the same hours for ward patients using CAM, and for ICU patients using CAM-ICU. If delirium is detected, delirium subtyping will be performed using the Richmond Agitation-Sedation Scale (RASS).

Procedure: ORi+SpO2

Interventions

control PROCEDURE

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

Control group

ORi+SpO2 PROCEDURE

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

ORi+SpO2 group

Eligibility Criteria

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

Study Population

Patients aged 65 and older. Geriatric patients

You may qualify if:

• Patients aged 65 and older
• Patients expected to have surgery lasting more than 2 hours
• Patients with ASA (American Society of Anesthesiologists) classification 1-2-3-4
• Patients planned to have at least 2 days of postoperative hospitalization

You may not qualify if:

• Patients with preoperative central nervous system disorders or dementia
• Patients with MMSE (Mini-Mental State Examination) scores of 23 or below
• Patients unable to communicate
• Emergency surgeries
• Patients who refuse to participate in the study
• Patients using high-dose vasopressors
• Patients with peripheral hypoperfusion
• Hemodynamically unstable patients

Sponsors & Collaborators

• Tepecik Training and Research Hospital: lead

Study Sites (1)

Aykut Saritaş

Izmir, 35640, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hyperoxia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associated professor

Study Record Dates

• First Submitted: March 16, 2024
• First Posted: March 22, 2024
• Study Start: October 1, 2023
• Primary Completion: July 5, 2024
• Study Completion: July 7, 2024
• Last Updated: July 9, 2024

Record last verified: 2024-03

Locations

TU (1)