Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Trial of Daily Sedative Interruption in Critically Ill, Mechanically Ventilated Patients Being Managed With a Sedation Protocol
Brief Summary: The purpose of this study is to determine whether the use of both a nurse-driven sedation protocol and daily sedative interruption, compared with a sedation protocol alone, result in better outcomes for mechanically ventilated adults.


Options:
A: Inclusion Criteria:

* Male or female adult patients admitted to the medical and surgical ICU for critical illnesses requiring mechanical ventilation with expectation of being mechanically ventilated for greater than 24 hours

Exclusion Criteria:

* Subjects who are less than 18 years of age
* Subjects who are pregnant (a pregnancy test will be performed on all women of child bearing age)
* Inability to obtain informed consent from the patient or his/her surrogate
* Subjects in the ICU due to a lack of beds elsewhere in the hospital, triage issues, or withdrawal of care decisions rather than severity of illness
* Subjects admitted with alcohol or drug overdoses, suicide attempts, or alcohol/delirium tremens
* Subjects who are physiologically benzodiazepine dependent, and at risk for withdrawal syndromes
* Subjects with chronic pain syndromes on maintenance narcotics
* Subjects treated within the last 30 days with a drug or device that has not received regulatory approval as of study entry
* Subjects with a psychiatric history for which they are on neuroleptic treatment
* Subjects with documented moderate to severe dementia
* Subjects with anoxic brain injuries, strokes, neurotrauma, or neuromuscular disorders such as myasthenia gravis or Guillain Barre syndrome
* Medical team following patient unwilling to use the sedation regimens
* Subjects whose family and/or physician have not committed to aggressive support for 72 hours or who are likely to withdraw within 72 hours
* Subjects who are moribund and not expected to survive 24 hours
* Subjects not expected to survive hospital discharge due to preexisting uncorrectable medical condition
* Documented allergy to study medications
* Subjects who have either Child-Pugh Class B or C cirrhosis
* Subjects with active coronary artery disease at time of screening as defined by any recent evidence of ischemia, documented myocardial infarction, or coronary intervention within the past 6 months.
* Subjects with advanced heart block at time of screening
B: Inclusion Criteria:

* Patients who are admitted to the intensive care unit and require invasive mechanical ventilation (endotracheal tube or tracheostomy) for more than 12 hours.
* Patients who are admitted to the intensive care unit and require non-invasive mechanical ventilation (BIPAP or CPAP with nasal or facial mask) for more than 1 hour.

Exclusion Criteria:

* Patients less than 18 years old
C: Inclusion Criteria:

* The attending physician thinks that the patient will be able to breathe spontaneously or the patients is already breathing spontaneously.
* No vasopressor or inotropic medication, unless the patient is receiving some digitalin or small doses of dopamine (\< 5 µg/kg/min)
* Slight or no endotracheal tube gas-leakage (\[Vti - Vte\]/Vti ≤ 20%)
* Mechanical ventilation with a plateau pressure ≤ 25 cmH2O over PEEP
* PEEP ≤ 8 cmH2O
* FiO2 ≤ 60% in order to obtain pulse oxymetry ≥ 95%
* PaCO2 \< 70 mmHg on the last blood gases
* Extubation not expected the day of inclusion

Exclusion Criteria:

* N/A
D: Inclusion Criteria:

* 18 years of age or over
* Mechanically ventilated, with anticipated need for MV ≥48 hrs
* ICU team has decided to initiate continuous sedative/analgesic infusion(s)
* informed consent from patient and/or SDM

Exclusion Criteria

* Admission after resuscitation from cardiac arrest
* Traumatic brain injury
* Currently receiving neuromuscular blocking agents
* Allergy to midazolam and lorazepam
* Lack of commitment to aggressive treatment
* Previous enrolment in SLEAP, or current enrolment in related trial

Answer: D