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The Efficacy of P0.1-guided Sedation Protocol in Critically Ill Patients Receiving Invasive Mechanical Ventilation: A Randomized Controlled Trial

ConditionsRespiratory FailureCritical IllnessRespiratory Distress Syndrome, AdultLung InjuryMechanical Ventilation Complication
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSiriraj Hospital

About this trial

This clinical trial aims to assess the efficacy of sedation protocol targeting optimal respiratory drive using P0.1 and arousal level compared with conventional sedation strategy (targeting arousal level alone) in patients requiring mechanical ventilation in the medical intensive care unit.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients admitted to the medical intensive care unit at Department of Medicine, Siriraj Hospital

Age ≥18 years old

Receiving mechanical ventilation due to acute respiratory failure within 72 hours before enrollment (including patients receiving mechanical ventilation before ICU admission)

Disqualifiers

Patients receiving mechanical ventilation due to indications other than acute respiratory failure, such as postoperative procedures or airway protection in comatose patients

Patients receiving mechanical ventilation for >72 hours before enrollment

Patients receiving neuromuscular blocking agents prior to randomization

Patients with impaired secretion clearance or upper airway obstruction anticipating a tracheostomy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Titrating sedation targeting both optimal P0.1 and appropriate arousal level

    Procedure/Surgery

    * Sedation will be adjusted initially to target light sedation (RASS 0 to -2). * Sedative drugs include IV fentanyl (25-75 mcg/h), midazolam (0.02- 0.1 mg/kg/h), propofol (5-50 mcg/kg/min), dexmedetomidine (0.2-0.7 mcg/kg/h). * Deep sedation and neuromuscular blocking agents are allowed to facilitate mechanical ventilation adjustment in patients with refractory hypoxemia. * Dose of cisatracurium is 0.15-0.2 mg/kg intravenous bolus, then continuous infusion at 5 -20 mg/h. * Then sedation adjustment will be guided by P0.1 measurement. * If P0.1 value of 1.5-3.5 cmH2O is achieved, no further adjustment is required. * If P0.1 value \<1.5, sedation will be reduced. * If P0.1 value \>3.5, sedation will be increased. * If P0.1 value is still \>3.5 with deep sedation, cisatracurium will be allowed and titrated until P0.1 value \<3.5 cmH2O. * The study protocol will be continued for 48 hours or until the patients are considered ready for weaning.

  • Fentanyl

    Drug

    Continuous intravenous infusion of fentanyl 25-75 micrograms/hour

  • Midazolam

    Drug

    Continuous intravenous infusion of midazolam 0.02 - 0.1 milligrams/kilogram/hour

  • Propofol

    Drug

    Continuous intravenous infusion of propofol 5 - 50 micrograms/kilogram/minute

  • Dexmedetomidine

    Drug

    Continuous intravenous infusion of dexmedetomidine 0.2 - 0.7 micrograms/kilogram/hour

  • Cisatracurium

    Drug

    Continuous intravenous infusion of cisatracurium 5 - 20 milligrams/hour

Treatment groups

214 Participants
are divided into 2 treatment groups
Group A: Titrating sedation targeting both optimal P0.1 and appropriate arousal levelExperimental treatment 6 interventions
Group B: Titrating sedation targeting appropriate arousal level aloneNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Successful extubation within 14 days after randomization

Successful extubation within 14 days without reintubation within 28 days after ICU admission

Time frame
14 days after randomization

Secondary outcomes

1

Successful extubation within 7 days after randomization

Successful extubation within 7 days without reintubation within 28 days after ICU admission

Time frame
7 days after randomization
2

Successful extubation within 28 days after randomization

Successful extubation without reintubation within 28 days after ICU admission

Time frame
28 days after randomization
3

Duration of mechanical ventilation

Time from intubation to the last successful extubation

Time frame
From date of intubation until the date of last successful extubation or date of death from any cause, whichever came first, assessed up to 28 days
4

Ventilator-free days to day 28 after randomization

Number of days alive without mechanical ventilation

Time frame
28 days after randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Siriraj Hospital

Lead sponsor

Source ClinicalTrials.gov
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