Intubation; Difficult Clinical Trial
Official title:
A Prospective, Randomized, Controlled Study on the Use of Dexmedetomidine to Facilitate Extubation in Surgical Intensive-Care-Unit Patients Who Failed Previous Weaning Attempts
Mechanical ventilation commonly is associated with patient agitation requiring sedation to
alleviate discomfort and reduce excessive central respiratory drive. Upon recovery from
acute respiratory failure, sedation is reduced to facilitate the withdrawal of ventilatory
support. In some patients, abrupt reduction in sedation provokes severe agitation that
causes catecholamine release resulting in severe hypertension, tachycardia and tachypnea.
This requires increased sedation to bring hemodynamic and respiratory function under
control.
Dexmedetomidine is an alpha-2 receptor agonist with both sedative and analgesic properties
that allows for the reduction in the anesthetic and analgesic requirements in the
perioperative setting. In addition to its sedative effects, alpha-2 receptor stimulation in
the central nervous system inhibits sympathetic activity and reduces plasma epinephrine and
norepinephrine levels, thereby lowering both arterial blood pressure and heart rate. Because
alpha-2 receptor stimulation does not cause respiratory depression, dexmedetomidine may
facilitate the transition to unassisted breathing in profoundly agitated patients. The
investigators will prospectively evaluate dexmedetomidine in 30 patients who could not be
extubated because of agitation with hemodynamic instability and tachypnea.
The purpose of this study is to test if a larger prospective randomized controlled pilot
study can show that dexmedetomidine facilitates weaning and extubation in patients who have
failed previous attempts because of agitation and hyperdynamic cardiopulmonary response.
Sixty patients who are admitted to the surgical intensive care unit (ICU) at San Francisco
General Hospital will be referred to the investigators for enrollment into a prospective,
unblinded, randomized study of dexmedetomidine. Each patient will be considered by the
critical care team as a suitable candidate for weaning and extubation based on inclusion/
exclusion criteria. Pregnant patients will not be enrolled and this will be determined by a
negative urine or serum pregnancy test from admission. If none is available a pregnancy test
will be performed prior to enrollment. Patients considered difficult to wean will be based
on the following criteria:
Eligible patients will be randomized to either the control arm or the dexmedetomidine arm in
a 1:1 ratio by using sealed envelopes.
Patient randomized to the control arm will be extubated per standard hospital protocol. This
arm of the study will be observational and these patients will be extubated by the attending
physician for that patient whenever they are hemodynamically stable enough to tolerate
another weaning trial. The study team will collect the same data points for the control arm
as in the dexmedetomidine arm. This includes ABGs, heart rate, mean blood pressure,
respiratory rate and RASS scores (see description below of data points and collection time
points.) Arterial blood gases will be drawn for the control arm of the study.
Patients on the dexmedetomidine arm will be started on dexmedetomidine at either 0.5
mcg/kg/hr or 0.7 mcg/kg/hr 1 hour prior to extubation. The drug calculation was based upon
an average taken between the patient's measured and predicted body weight. Background
sedation will be generally facilitated with lorazepam, midazolam or propofol, while
analgesia will be maintained with either fentanyl or hydromorphine. After starting
dexmedetomidine background sedation and analgesia will be titrated down and discontinued if
possible. Analgesia levels also will be reduced if tolerated. Dexmedetomidine will be
titrated according to blood pressure, RASS and heart rate response and the dose will be
lowered only after sedation is discontinued or markedly reduced. Aerosolized lidocaine (20
mg) therapy will be initiated prior to the weaning trial to prevent excessive coughing in
all patients.
Shortly after the dexmedetomidine infusion is started, PSV will be commenced at 5 cm H2O
above 5 cm H2O of continuous positive airway pressure (CPAP). Patients will be weaned to
CPAP and evaluated for extubation.
1.) Arterial blood gases will be obtained in all patients with an arterial line at three
points in time: just prior to dexmedetomidine infusion, during the CPAP trial, and
approximately 30 minutes after extubation.
3.) Heart rate, mean blood pressure, RASS, and respiratory rate will be collected at fifteen
minute intervals 1 hour prior to dexmedetomidine infusion, during the 1 hour infusion of
dexmedetomidine prior to the extubation then 5, 15, 30, 45, 60, 90 and 120 minutes after
extubation for a total of 4 hours of data collection.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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