Clinical Trials Directory

Trials / Completed

CompletedNCT07050719

Can Atelectasis Be Prevented With Oxygen Reserve Index (ORI) Monitoring?

Can Atelectasis be Prevented in Robotic Surgery by Monitoring With Oxygen Reserve Index (ORI)? A Randomized Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
58 (actual)
Sponsor
Antalya Training and Research Hospital · Other Government
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

This single-center randomized controlled trial aims to evaluate whether intraoperative monitoring using the Oxygen Reserve Index (ORI) reduces the incidence of postoperative atelectasis, as assessed by lung ultrasound (LUS), in adult patients undergoing elective robotic surgery under general anesthesia.

Detailed description

Postoperative atelectasis is observed in 60-90% of patients undergoing general anesthesia. Factors such as high inspired oxygen concentration, muscle relaxation, and reduced functional residual capacity contribute to its development through mechanisms like absorption atelectasis. The persistence of atelectasis increases the risk of pneumonia, hypoxia, prolonged hospital stay, healthcare costs, and mortality. Despite the well-known pathophysiology, the optimal intraoperative fraction of inspired oxygen (FiO₂) remains unclear. The Oxygen Reserve Index (ORI) is a non-invasive, continuous parameter that reflects the oxygen reserve within the moderate hyperoxia range (100-200 mmHg). It may facilitate individualized FiO₂ titration to avoid hyperoxia-related atelectasis. Lung ultrasound (LUS) is a reliable, radiation-free bedside tool for detecting atelectasis. This study hypothesizes that ORI-guided oxygen therapy will reduce the incidence of postoperative atelectasis compared to standard Peripheral Capillary Oxygen Saturation (SpO₂)-guided therapy.

Conditions

Interventions

TypeNameDescription
PROCEDUREPeripheral Oxygen Saturation (SpO₂) GroupFiO₂ adjusted based on pulse oximetry to maintain SpO₂ ≥98%
PROCEDUREPeripheral Oxygen Saturation and Oxygen Reserve Index (SpO₂-ORI) GroupFiO₂ adjusted using both SpO₂ and ORI to maintain ORI between 0-0.3

Timeline

Start date
2025-07-15
Primary completion
2025-12-08
Completion
2025-12-08
First posted
2025-07-03
Last updated
2025-12-10

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07050719. Inclusion in this directory is not an endorsement.