A randomized trial of daily awakening in critically ill patients managed with a sedation protocol : a pilot trial
OBJECTIVE: Protocolized sedation (PS) and daily sedative interruption (DI) in critically ill patients have both been shown to shorten the durations of mechanical ventilation (MV) and intensive care unit (ICU) stay. Our objective was to determine the safety and feasibility of a randomized trial to determine whether adults managed with both PS + DI have a shorter duration of MV than patients managed with PS alone.
DESIGN: Prospective randomized, concealed, unblinded, multicenter, pilot trial.
SETTING: Three university-affiliated medical-surgical ICUs.
PATIENTS: Sixty-five adults anticipated to require MV >48 hrs and receiving sedative/analgesic infusions.
INTERVENTIONS: Patients were randomized to PS alone, or PS + DI. PS was implemented by bedside nurses; sedatives/analgesics were titrated to achieve Sedation Agitation Score (SAS) 3-4. The PS + DI group also had infusions interrupted daily until the patients awoke.
MEASUREMENTS AND MAIN RESULTS: Diagnosis, age [mean +/- SD] (53 +/- 18.3 vs. 62.1 +/- 16.7 yrs) and Acute Physiology and Chronic Health Evaluation II (27.7 +/- 8.4 vs. 26.6 +/- 8.4) were similar in the PS and PS + DI groups, respectively. The median duration of MV in the PS and PS + DI groups was 8.0 vs. 10.5 days, and ICU stay was 10.0 vs. 13.0 days, respectively. The SAS was within target range (3-4) in 59% of 9,611 measurements, and within an acceptable range (2-5) in 86% of measurements. Self-assessed nursing and respiratory therapist workload was low in the majority of the cohort. Adverse events were similar in both groups. Patient recruitment was slower than projected (1.5 patients/mo).
CONCLUSION: This pilot trial comparing PS vs. PS + DI confirmed the safety and acceptability of the sedation protocol and DI, and guided important modifications to the protocol, thus enhancing the feasibility of a future multicenter trial. This trial was not designed to detect small but significant differences in clinically important outcomes.
| Errataetall: |
CommentIn: Crit Care Med. 2008 Jul;36(7):2205-6. - PMID 18594234 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2008 |
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| Erschienen: |
2008 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:36 |
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| Enthalten in: |
Critical care medicine - 36(2008), 7 vom: 15. Juli, Seite 2092-9 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Mehta, Sangeeta [VerfasserIn] |
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| Links: |
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| Themen: |
76I7G6D29C |
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| Anmerkungen: |
Date Completed 17.07.2008 Date Revised 30.03.2022 published: Print ClinicalTrials.gov: NCT00298493 CommentIn: Crit Care Med. 2008 Jul;36(7):2205-6. - PMID 18594234 Citation Status MEDLINE |
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| doi: |
10.1097/CCM.0b013e31817bff85 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
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| 100 | 1 | |a Mehta, Sangeeta |e verfasserin |4 aut | |
| 245 | 1 | 2 | |a A randomized trial of daily awakening in critically ill patients managed with a sedation protocol |b a pilot trial |
| 264 | 1 | |c 2008 | |
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| 500 | |a Date Completed 17.07.2008 | ||
| 500 | |a Date Revised 30.03.2022 | ||
| 500 | |a published: Print | ||
| 500 | |a ClinicalTrials.gov: NCT00298493 | ||
| 500 | |a CommentIn: Crit Care Med. 2008 Jul;36(7):2205-6. - PMID 18594234 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a OBJECTIVE: Protocolized sedation (PS) and daily sedative interruption (DI) in critically ill patients have both been shown to shorten the durations of mechanical ventilation (MV) and intensive care unit (ICU) stay. Our objective was to determine the safety and feasibility of a randomized trial to determine whether adults managed with both PS + DI have a shorter duration of MV than patients managed with PS alone | ||
| 520 | |a DESIGN: Prospective randomized, concealed, unblinded, multicenter, pilot trial | ||
| 520 | |a SETTING: Three university-affiliated medical-surgical ICUs | ||
| 520 | |a PATIENTS: Sixty-five adults anticipated to require MV >48 hrs and receiving sedative/analgesic infusions | ||
| 520 | |a INTERVENTIONS: Patients were randomized to PS alone, or PS + DI. PS was implemented by bedside nurses; sedatives/analgesics were titrated to achieve Sedation Agitation Score (SAS) 3-4. The PS + DI group also had infusions interrupted daily until the patients awoke | ||
| 520 | |a MEASUREMENTS AND MAIN RESULTS: Diagnosis, age [mean +/- SD] (53 +/- 18.3 vs. 62.1 +/- 16.7 yrs) and Acute Physiology and Chronic Health Evaluation II (27.7 +/- 8.4 vs. 26.6 +/- 8.4) were similar in the PS and PS + DI groups, respectively. The median duration of MV in the PS and PS + DI groups was 8.0 vs. 10.5 days, and ICU stay was 10.0 vs. 13.0 days, respectively. The SAS was within target range (3-4) in 59% of 9,611 measurements, and within an acceptable range (2-5) in 86% of measurements. Self-assessed nursing and respiratory therapist workload was low in the majority of the cohort. Adverse events were similar in both groups. Patient recruitment was slower than projected (1.5 patients/mo) | ||
| 520 | |a CONCLUSION: This pilot trial comparing PS vs. PS + DI confirmed the safety and acceptability of the sedation protocol and DI, and guided important modifications to the protocol, thus enhancing the feasibility of a future multicenter trial. This trial was not designed to detect small but significant differences in clinically important outcomes | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 7 | |a Hypnotics and Sedatives |2 NLM | |
| 650 | 7 | |a Neuromuscular Blocking Agents |2 NLM | |
| 650 | 7 | |a Morphine |2 NLM | |
| 650 | 7 | |a 76I7G6D29C |2 NLM | |
| 650 | 7 | |a Midazolam |2 NLM | |
| 650 | 7 | |a R60L0SM5BC |2 NLM | |
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| 700 | 1 | |a Martinez-Motta, J Carlos |e verfasserin |4 aut | |
| 700 | 1 | |a Stewart, Thomas E |e verfasserin |4 aut | |
| 700 | 1 | |a Hallett, David |e verfasserin |4 aut | |
| 700 | 1 | |a McDonald, Ellen |e verfasserin |4 aut | |
| 700 | 1 | |a Clarke, France |e verfasserin |4 aut | |
| 700 | 1 | |a Macdonald, Rod |e verfasserin |4 aut | |
| 700 | 1 | |a Granton, John |e verfasserin |4 aut | |
| 700 | 1 | |a Matte, Andrea |e verfasserin |4 aut | |
| 700 | 1 | |a Wong, Cindy |e verfasserin |4 aut | |
| 700 | 1 | |a Suri, Amit |e verfasserin |4 aut | |
| 700 | 1 | |a Cook, Deborah J |e verfasserin |4 aut | |
| 700 | 0 | |a Canadian Critical Care Trials Group |e verfasserin |4 aut | |
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