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Crit Care Med. 2020 Jan 6. doi: 10.1097/CCM.0000000000004176. [Epub ahead of print]

Promotion of Regular Oesophageal Motility to Prevent Regurgitation and Enhance Nutrition Intake in Long-Stay ICU Patients. A Multicenter, Phase II, Sham-Controlled, Randomized Trial: The PROPEL Study.

Author information

1
CIUSSS de-l'Est-de-l'Île-de-Montréal - Hôpital Maisonneuve-Rosemont, Montreal, QC, Canada.
2
Department of Critical Care Medicine, Université de Sherbrooke, Sherbrooke, QC, Canada.
3
Centre de recherche du CHU de Sherbrooke, Sherbrooke, QC, Canada.
4
Centre de Recherche Hôpital du Sacré-Cœur de Montréal, Université de Montréal, Montréal, QC, Canada.
5
CHU de Québec - Université Laval Research Center, Population Health and Optimal Health Practices Research Unit, (Traumatology-Emergency-Critical Care Medicine), Université Laval, Québec City, QC, Canada.
6
Division of Critical Care Medicine, Department of Anesthesiology and Critical Care Medicine, Université Laval, Québec City, QC, Canada.
7
Departments of Surgery and Critical Care Medicine, McGill University Health Centre, Montreal, QC, Canada.
8
Department of Medicine, University of Manitoba, Winnipeg, MB, Canada.
9
Nova Scotia Health Authority and the Department of Critical Care Medicine Dalhousie University, Halifax, NS, Canada.
10
Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
11
Department of Critical Care Medicine, Faculty of Medicine and Dentistry, The University of Alberta, Edmonton, AB, Canada.
12
Division of Critical Care Medicine, Department of Medicine, London Health Sciences Centre & Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.
13
Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH.
14
Clinical Evaluation Research Unit, Kingston General Hospital, Kingston, ON, Canada.

Abstract

OBJECTIVES:

To evaluate the effect of esophageal stimulation on nutritional adequacy in critically ill patients at risk for enteral feeding intolerance.

DESIGN:

A multicenter randomized sham-controlled clinical trial.

SETTING:

Twelve ICUs in Canada.

PATIENTS:

We included mechanically ventilated ICU patients who were given moderate-to-high doses of opioids and expected to remain alive and ventilated for an additional 48 hours and who were receiving enteral nutrition or expected to start imminently.

INTERVENTIONS:

Patients were randomly assigned 1:1 to esophageal stimulation via an esophageal stimulating catheter (E-Motion Tube; E-Motion Medical, Tel Aviv, Israel) or sham treatment. All patients were fed via these catheters using a standardized feeding protocol.

MEASUREMENTS AND MAIN RESULTS:

The co-primary outcomes were proportion of caloric and protein prescription received enterally over the initial 7 days following randomization. Among 159 patients randomized, the modified intention-to-treat analysis included 155 patients: 73 patients in the active treatment group and 82 in the sham treatment group. Over the 7-day study period, the percent of prescribed caloric intake (± SE) received by the enteral route was 64% ± 2 in the active group and 65% ± 2 in sham patients for calories (difference, -1; 95% CI, -8 to 6; p = 0.74). For protein, it was 57% ± 3 in the active group and 60% ± 3 in the sham group (difference, -3; 95% CI, -10 to 3; p = 0.30). Compared to the sham group, there were more serious adverse events reported in the active treatment group (13 vs 6; p = 0.053). Clinically important arrhythmias were detected by Holter monitoring in 36 out of 70 (51%) in the active group versus 22 out of 76 (29%) in the sham group (p = 0.006).

CONCLUSIONS:

Esophageal stimulation via a special feeding catheter did not improve nutritional adequacy and was associated with increase risk of harm in critically ill patients.

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