Background Daily interruption of continuous infusion of sedatives has improved outcomes in patients receiving mechanical ventilation in open-label studies. Objectives To assess the feasibility of a protocol for a double-blind, randomized, controlled trial study on the impact of routine daily interruption of sedation in patients receiving mechanical ventilation. Methods A total of 50 patients receiving mechanical ventilation were randomized to daily interruption of fentanyl and/or midazolam infusions for up to 6 hours or to usual management of sedation. Blinding was achieved by using replacement infusions (saline or active drug in saline). Results The recruitment target of 80 patients was not met in an extended time frame. Propofol was used outside the protocol in 27% of patients in the intervention group and 17% of patients in the control group (P = .10). A total of 15% of the intervention group and 12% of the control group never had replacement infusions started (P = .77), and replacement infusions were started on only approximately one-third of eligible days in patients who received replacement infusions. The mean doses of fentanyl and midazolam were similar. The blinding strategy was safe and effective: no patients had unplanned extubations, and the most frequent reason for ending replacement infusions was completion of the maximum 6-hour period. Conclusions The double-blinded design for assessment of sedation interruption in patients receiving mechanical ventilation was safe and effective. Slow recruitment of patients and frequent noncompliance with the protocol suggest that modifications to the protocol are needed.
AD - Leonie Weisbrodt is a senior research coordinator in the intensive care unit at Nepean Hospital, Penrith, New South Wales, Australia; a lecturer at the Sydney Nursing School, University of Sydney; and was a research student with the Faculty of Nursing, Midwifery and Health, University of Technology, Sydney, New South Wales during conduct of this project. Sharon McKinley is a professor of critical care nursing at the Faculty of Nursing, Midwifery and Health, University of Technology, Sydney, New South Wales, and the Northern Sydney Local Health District. Andrea P. Marshall is Sesqui senior lecturer in critical care at Sydney Nursing School, The University of Sydney, New South Wales. Louise Cole is a staff specialist in the Department of Intensive Care Medicine at Nepean Hospital and is subdean of education at the Nepean Clinical School, University of Sydney. Ian M. Seppelt is a staff specialist in the Department of Intensive Care Medicine at Nepean Hospital and is an honorary fellow in the critical care and trauma division of the George Institute in Sydney, New South Wales. Anthony Delaney is a staff specialist in the intensive care unit at Royal North Shore Hospital and a senior lecturer at Sydney Medical School-Northern, University of Sydney, St Leonards, New South Wales. AN - 21724628 BT - American Journal of Critical Care DA - -48254475307 ET - 2011/07/05 LA - Eng M1 - 4 N1 - American journal of critical care : an official publication, American Association of Critical-Care NursesAm J Crit Care. 2011 Jul;20(4):e90-e98. N2 -Background Daily interruption of continuous infusion of sedatives has improved outcomes in patients receiving mechanical ventilation in open-label studies. Objectives To assess the feasibility of a protocol for a double-blind, randomized, controlled trial study on the impact of routine daily interruption of sedation in patients receiving mechanical ventilation. Methods A total of 50 patients receiving mechanical ventilation were randomized to daily interruption of fentanyl and/or midazolam infusions for up to 6 hours or to usual management of sedation. Blinding was achieved by using replacement infusions (saline or active drug in saline). Results The recruitment target of 80 patients was not met in an extended time frame. Propofol was used outside the protocol in 27% of patients in the intervention group and 17% of patients in the control group (P = .10). A total of 15% of the intervention group and 12% of the control group never had replacement infusions started (P = .77), and replacement infusions were started on only approximately one-third of eligible days in patients who received replacement infusions. The mean doses of fentanyl and midazolam were similar. The blinding strategy was safe and effective: no patients had unplanned extubations, and the most frequent reason for ending replacement infusions was completion of the maximum 6-hour period. Conclusions The double-blinded design for assessment of sedation interruption in patients receiving mechanical ventilation was safe and effective. Slow recruitment of patients and frequent noncompliance with the protocol suggest that modifications to the protocol are needed.
PY - 2011 SN - 1937-710X (Electronic)1062-3264 (Linking) SP - e90 EP - e98 T2 - American Journal of Critical Care TI - Daily Interruption of Sedation in Patients Receiving Mechanical Ventilation VL - 20 ER -