OBJECTIVE: To examine whether patients assessed for initiation of oral intake only by Facial-Oral Tract Therapy had a greater risk of developing aspiration pneumonia during neurorehabilitation than patients assessed by Fibreoptic Endoscopic Evaluation of Swallowing. DESIGN: Randomized controlled trial. SETTING: Specialized, national neurorehabilitation centre. SUBJECTS:Adult patients with acquired brain injury. Six hundred and seventy-nine patients were assessed for eligibility and 138 were randomly allocated between June 2009 and April 2011. INTERVENTIONS: Assessment by Facial-Oral Tract Therapy (control group) or Fibreoptic Endoscopic Evaluation of Swallowing (intervention group). MAIN MEASURE: Primary outcome was the number of aspiration pneumonias that developed after initiation of oral intake. RESULTS:One hundred and nineteen patients were included in the analysis of the primary outcome (62 controls/57 interventions). Sixteen patients were clinically diagnosed with pneumonia (4 controls/12 interventions). Nine patients had to be excluded: 6 patients got pneumonia before initiating oral intake; 3 patients with the clinical diagnosis of pneumonia did not show radiological signs. Seven patients were left for analysis, 4 of whom developed aspiration pneumonia within 10 days after initiating oral intake (1 control/3 interventions). CONCLUSION: In the presence of a structured clinical assessment with the Facial-Oral Tract Therapy approach, it is unnecessary to undertake an instrumental investigation of swallowing before initiation of oral intake.
RCT Entities:
OBJECTIVE: To examine whether patients assessed for initiation of oral intake only by Facial-Oral Tract Therapy had a greater risk of developing aspiration pneumonia during neurorehabilitation than patients assessed by Fibreoptic Endoscopic Evaluation of Swallowing. DESIGN: Randomized controlled trial. SETTING: Specialized, national neurorehabilitation centre. SUBJECTS: Adult patients with acquired brain injury. Six hundred and seventy-nine patients were assessed for eligibility and 138 were randomly allocated between June 2009 and April 2011. INTERVENTIONS: Assessment by Facial-Oral Tract Therapy (control group) or Fibreoptic Endoscopic Evaluation of Swallowing (intervention group). MAIN MEASURE: Primary outcome was the number of aspiration pneumonias that developed after initiation of oral intake. RESULTS: One hundred and nineteen patients were included in the analysis of the primary outcome (62 controls/57 interventions). Sixteen patients were clinically diagnosed with pneumonia (4 controls/12 interventions). Nine patients had to be excluded: 6 patients got pneumonia before initiating oral intake; 3 patients with the clinical diagnosis of pneumonia did not show radiological signs. Seven patients were left for analysis, 4 of whom developed aspiration pneumonia within 10 days after initiating oral intake (1 control/3 interventions). CONCLUSION: In the presence of a structured clinical assessment with the Facial-Oral Tract Therapy approach, it is unnecessary to undertake an instrumental investigation of swallowing before initiation of oral intake.