Closed-Loop O2 Use During High Flow Oxygen Treatment of Critical Care Adult Patients (CLOUDHFOT)

Launched by BAŞAKŞEHIR ÇAM & SAKURA CITY HOSPITAL · Apr 16, 2024

Keywords

ClinConnect Summary

The CLOUDHFOT clinical trial is studying a new system that automatically adjusts the amount of oxygen given to patients in the Emergency Room (ER) who need high-flow nasal oxygen therapy (HFNO). This therapy is used for patients experiencing severe breathing problems, and the goal is to keep their blood oxygen levels within a safe range. The new system is designed to help ensure that patients get just the right amount of oxygen without giving too much, which can be harmful. Researchers hope that this automatic system will help patients maintain better oxygen levels compared to traditional manual methods.

To participate in the trial, patients must be over 18 years old and admitted to the ER needing HFNO with a certain level of oxygen support. They should also be able to provide informed consent, either themselves or through a family member if they're unable to do so. During the trial, participants will receive oxygen treatment with the new closed-loop system, which adjusts oxygen levels as needed. This study is important because it could lead to better care for patients with severe breathing issues, especially in fast-paced environments like the ER.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient admitted to the ER
• • Requiring NHFO
• • Requiring FiO2 ≥ 30% to keep SpO2 in the target ranges defined by the clinician
• • Aged over 18 years
• • Written informed consent signed and dated by the patient or one relative in case that the patient is unable to consent, after full explanation of the study by the investigator and prior to study participation
• • In case that the consent is given by the relative, patient consent will be requested as soon as the patient will be able to provide informed written consent
• Exclusion Criteria:
• Patients who fulfil any of the following exclusion criteria are not eligible for study participation:
• • Patient with indication for immediate CPAP, NIV, or invasive mechanical ventilation
• • Hemodynamic instability defined as a need of continuous infusion of epinephrine or norepinephrine \> 1 mg/h
• • Low quality on the SpO2 measurement using finger and ear sensor (quality index below 60% on the Massimo SpO2 sensor, which is displayed by a red or orange color bar)
• • Severe acidosis (pH ≤ 7.30)
• • Pregnant woman
• • Patients deemed at high risk for need of mechanical ventilation within the next 12 hours
• • Chronic or acute dyshemoglobinemia: methemoglobin, CO poisoning, sickle cell disease
• • Tracheotomized patient
• • Formalized ethical decision to withhold or withdraw life support
• • Patient under guardianship
• • Patient deprived of liberties
• • Patient included in another interventional research study under consent
• • Patient already enrolled in the present study in a previous episode of acute respiratory failure
• • Post enrollment exclusion criteria
• • Apparition of a persistent low quality SpO2 signal
• • Need for an emergent intubation
• • Discharge from ER