Optimization of Respiratory Effort With Titrated Sedation in AHRF

NCT07679932 | Not Yet Recruiting

• 1 other identifier: 27387-1
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

AHRF

Outcome Measures

Primary Outcomes (1)

• Inspiratory effort, expressed in cmH2O

  Negative deflection in esophageal pressure during inspiration

  During procedure

Secondary Outcomes (13)

• Dyspnea

  During procedure

• Discomfort

  During procedure

• PaO2/FiO2 ratio

  During procedure

• Respiratory rate

  During procedure

• Recuitment of expiratory muscles, expressed in cmH2O of gastric pressure

  During procedure

Study Arms (2)

Dexmedetomidine during HFNC

The procedure performed as part of routine clinical practice involves the administration of high-flow nasal oxygen therapy (HFNC), with an initial flow set at 60 L/min, potentially reduced to the maximum tolerated flow in case of discomfort. FiO₂ is titrated to maintain the target SpO₂ of 92-96%. Humidification chamber is heated at 37°C or 34°C according to patient's comfort. During the procedure, patients receive sedative-analgesic treatment with dexmedetomidine as a clinical indication decided by the attending physician.

Remifentanil during HFNC

The procedure performed as part of routine clinical practice involves the administration of high-flow nasal oxygen therapy (HFNC), with an initial flow set at 60 L/min, potentially reduced to the maximum tolerated flow in case of discomfort. FiO₂ is titrated to maintain the target SpO₂ of 92-96%. Humidification chamber is heated at 37°C or 34°C according to patient's comfort. During the procedure, patients receive sedative-analgesic treatment with remifentanil as a clinical indication decided by the attending physician.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hypoxemic respiratory failure treated with high-flow oxygen therapy for whom the attending physician, based on clinical indications, has decided to initiate sedative-analgesic treatment with dexmedetomidine or remifentanil. The study plans to enroll 40 patients, including 20 patients treated with dexmedetomidine and 20 patients treated with remifentanil.

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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A.Gemelli IRCCS

Roma, RM, 00168, Italy

Location

Central Study Contacts

Domenico Luca Grieco, MD

CONTACT

+393397681623; dlgrieco@outlook.it

Gaia Tempo, MD

CONTACT

+393450947767; gaia.tempo9@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Principal Investigator

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: July 1, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 1, 2026

Record last verified: 2026-06

Locations

IT (1)