NCT02810080

FiO2 Closed Loop Control Ventilation

FiO2 Closed Loop Control Using the ZOLL 731 Series Ventilator

• Status: Completed
• Phase: —
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Zoll Medical Corporation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A randomized, multi-center trial involving critically-ill patients comparing conventional, manual control of inspired oxygen (FiO2) within a target range, with a computer-controlled, closed-loop FiO2 delivery using a continuous ventilator.

Detailed description

The trial will use a proportional-integral-derivative (PID) type controller for automatic adjustment of FiO2 to maintain the SpO2 within a target range, based on continuous use of pulse oximetry. Intubated subjects will be randomized to either manual control of FiO2 or closed-loop control of FiO2, during a 12-hour period. The PCLC is designed to respond to acute hypoxemia (SpO2 \<88%) within seconds while preventing hypoxemia and minimizing exposure to excessive inspired oxygen levels.

Conditions

• Wounds and Injuries
• Respiratory Failure

Interventions

Type	Name	Description
DEVICE	Closed Loop Control Ventilation	Closed loop control ventilation using ZOLL 731 ventilator with physiologic closed-loop control software
DEVICE	Manual Control Ventilation	Manual control ventilation using ZOLL 731 ventilator

Timeline

• Start date: 2016-12-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2016-06-22
• Last updated: 2024-08-15
• Results posted: 2024-08-15

Locations

1 site across 1 country: United States