Usefulness of oxygen reserve index (ORI) to avoid excessive hyperoxia undergoing orthopedic or general trauma surgery during general anesthesia: A prospective, randomized, open study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0008379

Enrollment

Registered

2023-04-21

Start date

2023-03-01

Completion date

Unknown

Last updated

2023-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : ? Upon the patient's arrival in the operating room, the ORI monitor should be attached simultaneously with other mornitoring devices, regardless of whether the patient is planned to r

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Trauma patients undergoing orthopedic or trauma surgery under general anesthesia Patients with ASA class 3 or higher Patients who have already had invasive arterial line or are scheduled to be placed and monitored during surgery Age: 20 to 79 years old Multiple trauma with/without heart or lung contusion Patients undergoing induction of general anesthesia in the operating room or already intubated in a trauma bay or ICU Patients with sufficient lung function to tolerate an initial FiO2 of up to 0.5 immediately after intubation Acute Respiratory Distress Syndrome ARDS, depending on the severity of ARDS, patients who can maintain SpO2 above 95% with an initial FiO2 of 0.5 If the consent of the principal or a guardian in a legal representative relationship (when the consent of the individual is impossible due to intubation, etc.) can be obtained in advance

Exclusion criteria

Exclusion criteria: Patients unable to maintain an SpO2 of 95 or higher from an initial FiO2 of 0.5 immediately after intubation pregnancy

Design outcomes

Primary

Measure	Time frame
Incidence of hyperoxia ;The percentage of hours with moderate hyperoxia	—

Secondary

Measure	Time frame
Minimum and maximum intraoperative FiO2 ;Minimum and maximum intraoperative PaO2 ;Number of hours with PaO2 equal or above to 100, 150, and 200 mmHg ;Number of intraoperative hypoxemia episode(defined by PaO2<60 mmHg);Number of atelectasis episodes, pneumonia, pulmonary edema, respiratory failure, surgical site infection, sepsis, mortality (within 7 days & within 28 days)	—

Countries

Korea, Republic of

Contacts

Public ContactTae Kwang Kim

Ajou University Hospital

itsagoodtimee@gmail.com+82-31-219-6434

Outcome results