Optimization of Respiratory Effort With Titrated Sedation in AHRF

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Conditions studied: AHRF

In brief

Prospective, observational, monocentric study to assess the physiological effects of dexmedetomidine and remifentanil in spontaneously breathing patients with acute hypoxemic respiratory failure receiving high-flow nasal oxygen.

Key facts

Study ID

NCT07679932

Run by

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

People needed

40

Starts

2026-07-01

Expected to finish

2028-07-01

Last updated by the study team

2026-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years
• PaO2/FiO2 ratio ≤ 200;
• PaCO2 < 45 mmHg;
• At least one symptom prompting the use of sedative-analgesic drugs according to the prescription of the attending physician: dyspnea and/or discomfort equal of greater than 4/10 (Visual Analog Scale - VAS), respiratory rate equal or greater than 25 breaths per minute, PaCO2<35 mmHg, pain (Numeric Rating Scale ≥ 4 or Behavioral Pain Scale - Non-Intubated ≥ 4);
• Informed consent signature.

You may not qualify if…

• Pregnancy;
• Exacerbation of asthma or chronic obstructive pulmonary disease;
• Chronic lung disease, requiring oxygen therapy at home;
• Cardiogenic pulmonary oedema;
• Hemodynamic instability (systolic blood pressure <90 mmHg or mean arterial pressure <65 mmHg) and/or lactic acidosis (lactate >5 mmol/L) and/or clinically diagnosed shock;
• Metabolic acidosis (pH <7.30 with normal or hypocarbia);
• Glasgow Coma Scale <13;
• Contraindications to esophageal balloon and/or EIT placement.

Where it is running

• Fondazione Policlinico Universitario A.Gemelli IRCCS — Roma, RM, Italy

Full record on ClinicalTrials.gov

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