Optimization of Respiratory Effort With Titrated Sedation in AHRF
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: AHRF. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Optimization of Respiratory Effort With Titrated Sedation in Patients With Acute Hypoxemic Respiratory Failure - The OPTIREST Study
Overview
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.
Detailed description
Sedation in spontaneously breathing hypoxemic patients represents a critical physiological trade-off between lung protection and maintenance of adequate ventilation. While spontaneous breathing is generally encouraged to preserve diaphragm function and avoid invasive ventilation, excessive respiratory drive may promote patient self-inflicted lung injury (P-SILI) through increased inspiratory effort, elevated transpulmonary pressure swings, pendelluft phenomena, and regional stress amplification. Conversely, excessive sedation may suppress respiratory drive, resulting in hypoventilation, impaired gas exchange, and diaphragm disuse. Sedation therefore behaves as a double-edged sword, requiring careful titration to balance lung protection and adequate ventilation. Despite the widespread use of dexmedetomidine and remifentanil in this setting, limited information is available regarding their dose-dependent physiological effects on inspiratory effort, transpulmonary pressure, regional ventilation distribution, expiratory muscle recruitment, and lung stress. Current clinical practice relies mainly on symptom control (dyspnea, agitation, tachypnea) without direct assessment of the mechanical and regional effects of sedation on the injured lung; consequently, sedation strategies remain largely empirical and poorly standardized. The study aims to characterize the effects of sedation administered through Target-Controlled Infusion (TCI) on respiratory mechanics and regional lung behavior in spontaneously breathing patients receiving high-flow nasal oxygen. By integrating esophageal pressure monitoring and electrical impedance tomography, the effects of increasing effect-site concentrations of dexmedetomidine or remifentanil on inspiratory effort and its regional consequences will be investigated.
Primary outcome measures
- Inspiratory effort, expressed in cmH2O [Time frame: During procedure]
Secondary outcome measures (12)
- Dyspnea [Time frame: During procedure]
- Discomfort [Time frame: During procedure]
- PaO2/FiO2 ratio [Time frame: During procedure]
- Respiratory rate [Time frame: During procedure]
- Recuitment of expiratory muscles, expressed in cmH2O of gastric pressure [Time frame: During procedure]
- Tidal volume distribution [Time frame: During procedure]
- End-expiratory lung volume [Time frame: During procedure]
- Regional End-expiratory lung volume [Time frame: During procedure]
- Dynamic transpulmonary driving pressure [Time frame: During procedure]
- Global impedance-derived lung dynamic strain [Time frame: During procedure]
- Regional impedance-derived lung dynamic strain [Time frame: During procedure]
- Pendelluft [Time frame: During procedure]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Italy · 1 center
- Fondazione Policlinico Universitario A.Gemelli IRCCS — Roma
Identifiers
NCT: NCT07679932 · 27387-1