Early goal-directed sedation versus standard sedation in mechanically ventilated critically III patients: a pilot study

Yahya Shehabi, Rinaldo Bellomo, Michael C Reade, Michael John Bailey, Frances Bass, Belinda Duval Howe, Colin McArthur, Lynnette Joy Murray, Ian M Seppelt, Steven Webb, Leonie Weisbrodt

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Abstract

Objective: To assess the feasibility and safety of delivering early goal-directed sedation compared with standard sedation. Design: Pilot prospective, multicenter, randomized, controlled trial. Setting: Six ICUs. Patients: Critically ill adults mechanically ventilated for greater than 24 hours. Interventions: Patients randomized to early goal-directed sedation received a dexmedetomidine-based algorithm targeted to light sedation (Richmond Agitation Sedation Score of -2 to 1). Patients randomized to standard sedation received propofol and/or midazolam-based sedation as clinically appropriate. Measurements and Main Results: The main feasibility outcomes were time to randomization and proportion of Richmond Agitation Sedation Score assessments in the first 48 hours in the light and deep sedation range. Safety outcomes were delirium-free days, vasopressor and physical restraints use, and device removal. Randomization occurred within a median (interquartile range) of 1.1 hours (0.46-1.9) after intubation or ICU admission for out of ICU intubation. Patients in the early goal-directed sedation (n = 21) mean (SD) Acute Physiology and Chronic Health Evaluation II score was 20.2 (6.2) versus 18.6 (8.8; p = 0.53) in the standard sedation (n = 16). A significantly higher proportion of patients was lightly sedated on days 1, 2, and 3 (12/19 [63.2 , 19/21 [90.5 , and 18/20 [90 vs 2/14 [14.3 , 8/15 [53.3 , and 9/15 [60 ; p = 0.005, 0.011, 0.036) and more Richmond Agitation Sedation Scale assessments between (-2 and 1), in the first 48 hours (203/307 [66 versus (74/197 [38 ; p = 0.01) in the early goal-directed sedation versus standard sedation, respectively. Early goal-directed sedation patients received midazolam on 6 of 173 (3.5 ) versus 4 of 114 (3.5 ) standard sedation patient-days when dexmedetomidine was given. Propofol was given to 16 of 21 (76 ) of early goal-directed sedation versus 16 of 16 (100 ) of standard sedation patients (p = 0.04). Early goal-directed sedation patients had 101 of 175 (58 ) versus 54 of 114 (47 ; p = 0.27) delirium-free days and required significantly less physical restraints 1 (5 ) versus 5 (31 ; p = 0.03) than standard sedation patients. There were no differences in vasopressor use and self-extubation. Conclusions: Delivery of early goal-directed sedation was feasible, appeared safe, achieved early light sedation, minimized benzodiazepines and propofol, and decreased the need for physical restraints. The findings of this pilot study justify further investigation of early goal-directed sedation.
Original languageEnglish
Pages (from-to)1983 - 1991
Number of pages9
JournalCritical Care Medicine
Volume41
Issue number8
DOIs
Publication statusPublished - 2013

Cite this

@article{935e6c9e0ddd4305986a6f81ea88b92a,
title = "Early goal-directed sedation versus standard sedation in mechanically ventilated critically III patients: a pilot study",
abstract = "Objective: To assess the feasibility and safety of delivering early goal-directed sedation compared with standard sedation. Design: Pilot prospective, multicenter, randomized, controlled trial. Setting: Six ICUs. Patients: Critically ill adults mechanically ventilated for greater than 24 hours. Interventions: Patients randomized to early goal-directed sedation received a dexmedetomidine-based algorithm targeted to light sedation (Richmond Agitation Sedation Score of -2 to 1). Patients randomized to standard sedation received propofol and/or midazolam-based sedation as clinically appropriate. Measurements and Main Results: The main feasibility outcomes were time to randomization and proportion of Richmond Agitation Sedation Score assessments in the first 48 hours in the light and deep sedation range. Safety outcomes were delirium-free days, vasopressor and physical restraints use, and device removal. Randomization occurred within a median (interquartile range) of 1.1 hours (0.46-1.9) after intubation or ICU admission for out of ICU intubation. Patients in the early goal-directed sedation (n = 21) mean (SD) Acute Physiology and Chronic Health Evaluation II score was 20.2 (6.2) versus 18.6 (8.8; p = 0.53) in the standard sedation (n = 16). A significantly higher proportion of patients was lightly sedated on days 1, 2, and 3 (12/19 [63.2 , 19/21 [90.5 , and 18/20 [90 vs 2/14 [14.3 , 8/15 [53.3 , and 9/15 [60 ; p = 0.005, 0.011, 0.036) and more Richmond Agitation Sedation Scale assessments between (-2 and 1), in the first 48 hours (203/307 [66 versus (74/197 [38 ; p = 0.01) in the early goal-directed sedation versus standard sedation, respectively. Early goal-directed sedation patients received midazolam on 6 of 173 (3.5 ) versus 4 of 114 (3.5 ) standard sedation patient-days when dexmedetomidine was given. Propofol was given to 16 of 21 (76 ) of early goal-directed sedation versus 16 of 16 (100 ) of standard sedation patients (p = 0.04). Early goal-directed sedation patients had 101 of 175 (58 ) versus 54 of 114 (47 ; p = 0.27) delirium-free days and required significantly less physical restraints 1 (5 ) versus 5 (31 ; p = 0.03) than standard sedation patients. There were no differences in vasopressor use and self-extubation. Conclusions: Delivery of early goal-directed sedation was feasible, appeared safe, achieved early light sedation, minimized benzodiazepines and propofol, and decreased the need for physical restraints. The findings of this pilot study justify further investigation of early goal-directed sedation.",
author = "Yahya Shehabi and Rinaldo Bellomo and Reade, {Michael C} and Bailey, {Michael John} and Frances Bass and Howe, {Belinda Duval} and Colin McArthur and Murray, {Lynnette Joy} and Seppelt, {Ian M} and Steven Webb and Leonie Weisbrodt",
year = "2013",
doi = "10.1097/CCM.0b013e31828a437d",
language = "English",
volume = "41",
pages = "1983 -- 1991",
journal = "Critical Care Medicine",
issn = "0090-3493",
publisher = "Lippincott Williams & Wilkins",
number = "8",

}

Early goal-directed sedation versus standard sedation in mechanically ventilated critically III patients: a pilot study. / Shehabi, Yahya; Bellomo, Rinaldo; Reade, Michael C; Bailey, Michael John; Bass, Frances; Howe, Belinda Duval; McArthur, Colin; Murray, Lynnette Joy; Seppelt, Ian M; Webb, Steven; Weisbrodt, Leonie.

In: Critical Care Medicine, Vol. 41, No. 8, 2013, p. 1983 - 1991.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Early goal-directed sedation versus standard sedation in mechanically ventilated critically III patients: a pilot study

AU - Shehabi, Yahya

AU - Bellomo, Rinaldo

AU - Reade, Michael C

AU - Bailey, Michael John

AU - Bass, Frances

AU - Howe, Belinda Duval

AU - McArthur, Colin

AU - Murray, Lynnette Joy

AU - Seppelt, Ian M

AU - Webb, Steven

AU - Weisbrodt, Leonie

PY - 2013

Y1 - 2013

N2 - Objective: To assess the feasibility and safety of delivering early goal-directed sedation compared with standard sedation. Design: Pilot prospective, multicenter, randomized, controlled trial. Setting: Six ICUs. Patients: Critically ill adults mechanically ventilated for greater than 24 hours. Interventions: Patients randomized to early goal-directed sedation received a dexmedetomidine-based algorithm targeted to light sedation (Richmond Agitation Sedation Score of -2 to 1). Patients randomized to standard sedation received propofol and/or midazolam-based sedation as clinically appropriate. Measurements and Main Results: The main feasibility outcomes were time to randomization and proportion of Richmond Agitation Sedation Score assessments in the first 48 hours in the light and deep sedation range. Safety outcomes were delirium-free days, vasopressor and physical restraints use, and device removal. Randomization occurred within a median (interquartile range) of 1.1 hours (0.46-1.9) after intubation or ICU admission for out of ICU intubation. Patients in the early goal-directed sedation (n = 21) mean (SD) Acute Physiology and Chronic Health Evaluation II score was 20.2 (6.2) versus 18.6 (8.8; p = 0.53) in the standard sedation (n = 16). A significantly higher proportion of patients was lightly sedated on days 1, 2, and 3 (12/19 [63.2 , 19/21 [90.5 , and 18/20 [90 vs 2/14 [14.3 , 8/15 [53.3 , and 9/15 [60 ; p = 0.005, 0.011, 0.036) and more Richmond Agitation Sedation Scale assessments between (-2 and 1), in the first 48 hours (203/307 [66 versus (74/197 [38 ; p = 0.01) in the early goal-directed sedation versus standard sedation, respectively. Early goal-directed sedation patients received midazolam on 6 of 173 (3.5 ) versus 4 of 114 (3.5 ) standard sedation patient-days when dexmedetomidine was given. Propofol was given to 16 of 21 (76 ) of early goal-directed sedation versus 16 of 16 (100 ) of standard sedation patients (p = 0.04). Early goal-directed sedation patients had 101 of 175 (58 ) versus 54 of 114 (47 ; p = 0.27) delirium-free days and required significantly less physical restraints 1 (5 ) versus 5 (31 ; p = 0.03) than standard sedation patients. There were no differences in vasopressor use and self-extubation. Conclusions: Delivery of early goal-directed sedation was feasible, appeared safe, achieved early light sedation, minimized benzodiazepines and propofol, and decreased the need for physical restraints. The findings of this pilot study justify further investigation of early goal-directed sedation.

AB - Objective: To assess the feasibility and safety of delivering early goal-directed sedation compared with standard sedation. Design: Pilot prospective, multicenter, randomized, controlled trial. Setting: Six ICUs. Patients: Critically ill adults mechanically ventilated for greater than 24 hours. Interventions: Patients randomized to early goal-directed sedation received a dexmedetomidine-based algorithm targeted to light sedation (Richmond Agitation Sedation Score of -2 to 1). Patients randomized to standard sedation received propofol and/or midazolam-based sedation as clinically appropriate. Measurements and Main Results: The main feasibility outcomes were time to randomization and proportion of Richmond Agitation Sedation Score assessments in the first 48 hours in the light and deep sedation range. Safety outcomes were delirium-free days, vasopressor and physical restraints use, and device removal. Randomization occurred within a median (interquartile range) of 1.1 hours (0.46-1.9) after intubation or ICU admission for out of ICU intubation. Patients in the early goal-directed sedation (n = 21) mean (SD) Acute Physiology and Chronic Health Evaluation II score was 20.2 (6.2) versus 18.6 (8.8; p = 0.53) in the standard sedation (n = 16). A significantly higher proportion of patients was lightly sedated on days 1, 2, and 3 (12/19 [63.2 , 19/21 [90.5 , and 18/20 [90 vs 2/14 [14.3 , 8/15 [53.3 , and 9/15 [60 ; p = 0.005, 0.011, 0.036) and more Richmond Agitation Sedation Scale assessments between (-2 and 1), in the first 48 hours (203/307 [66 versus (74/197 [38 ; p = 0.01) in the early goal-directed sedation versus standard sedation, respectively. Early goal-directed sedation patients received midazolam on 6 of 173 (3.5 ) versus 4 of 114 (3.5 ) standard sedation patient-days when dexmedetomidine was given. Propofol was given to 16 of 21 (76 ) of early goal-directed sedation versus 16 of 16 (100 ) of standard sedation patients (p = 0.04). Early goal-directed sedation patients had 101 of 175 (58 ) versus 54 of 114 (47 ; p = 0.27) delirium-free days and required significantly less physical restraints 1 (5 ) versus 5 (31 ; p = 0.03) than standard sedation patients. There were no differences in vasopressor use and self-extubation. Conclusions: Delivery of early goal-directed sedation was feasible, appeared safe, achieved early light sedation, minimized benzodiazepines and propofol, and decreased the need for physical restraints. The findings of this pilot study justify further investigation of early goal-directed sedation.

UR - http://www.ncbi.nlm.nih.gov/pubmed/23863230

U2 - 10.1097/CCM.0b013e31828a437d

DO - 10.1097/CCM.0b013e31828a437d

M3 - Article

VL - 41

SP - 1983

EP - 1991

JO - Critical Care Medicine

JF - Critical Care Medicine

SN - 0090-3493

IS - 8

ER -