Optimization of Respiratory Effort With Titrated Sedation in AHRF
ConditionAHRF
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
Pregnancy;
Exacerbation of asthma or chronic obstructive pulmonary disease;
Chronic lung disease, requiring oxygen therapy at home;
Cardiogenic pulmonary oedema;
Trial 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
40 Participants
are grouped into 2 trial groupsGroup A: Dexmedetomidine during HFNC
Group B: Remifentanil during HFNC
Trial outcomes
Primary outcomes
1
Inspiratory effort, expressed in cmH2O
Negative deflection in esophageal pressure during inspiration
Time frame
During procedureSecondary outcomes
1
Dyspnea
Defined according to visual analog scale of dyspnea (0-10, where 10 represents worst perceivable dyspnea)
Time frame
During procedure2
Discomfort
Defined according to visual analog scale of discomfort (0-10, where 10 represents worst perceivable discomfort).
Time frame
During procedure3
PaO2/FiO2 ratio
Change in arterial Pa/FiO2 (in mmHg)
Time frame
During procedure4
Respiratory rate
Change in respiratory rate (breaths/minute)
Time frame
During procedureSponsors and contacts
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Source ClinicalTrials.gov
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