Perioperative Oral Decontamination and ImmunoNuTrition (POINT) in Elderly
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorPeking Union Medical College Hospital
About this trial
The goal of this multicenter randomized controlled trial is to explore the efficacy of perioperative oral decontamination and immunonutrition supplement to prevent postoperative pulmonary complications in elderly patients(≥65 years) receiving elective non-cardiac operations. Participants will be either given immunonutrition supplement versus routine nutrition advice, and oral chlorhexidine decontamination versus routine oral care randomly. The two interventions will be compared with control groups separately regarding postoperative pulmonary complications and other outcomes.
Eligibility criteria
Qualifiers
age≥65 years;
undergoing major non-cardiac surgery;
scheduled for general anesthesia and endotracheal intubation;
American Society of Anesthesiologists (ASA) physical status classification I-IV;
Disqualifiers
emergency surgery;
preoperative pneumonia;
allergic to chlorhexidine;
severe hepatic/renal dysfunction, incapable of oral feeding, with autoimmune diseases, taking immunosuppressant or immunoregulation medications, or with other contraindication to immunonutrition supplementation;
Trial design
Treatments tested in this trial
- immunonutrition supplement of ORAL IMPACT™
- oral chlorhexidine decontamination
Treatment groups
592 Participants
are divided into 4 treatment groupsSponsors and collaborators
Peking Union Medical College Hospital
Lead sponsor
Fujian Provincial Hospital
Collaborator
The Second Hospital of Hebei Medical University
Collaborator
Shenzhen Nanshan District Shekou People's Hospital
Collaborator
Ningbo No.2 Hospital
Collaborator
Peking University International Hospital
Collaborator
Guizhou Provincial People's Hospital
Collaborator
Source ClinicalTrials.gov