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Perioperative Oral Decontamination and ImmunoNuTrition (POINT) in Elderly

ConditionsPostoperative ComplicationsPulmonary Complication
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

This trial does not accept healthy volunteers

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

Design model

Factorial

Treatments tested in this trial

  • immunonutrition supplement of ORAL IMPACT™

    Dietary supplement

    For intervention group, patients will take immunonutrition supplement after recruitment until the day before surgery.

  • oral chlorhexidine decontamination

    Other intervention

    For intervention group, patients will use 0.12% chlorhexidine for oral rinse twice daily from the day before surgery until 3 days after surgery.

Treatment groups

592 Participants
are divided into 4 treatment groups
Group A: Group A (immunonutrition and oral chlorhexidine decontamination, IN&CD)Experimental treatment 2 interventions
Group B: Group B (immunonutrition and routine oral care, IN&RC)Experimental treatment 1 intervention
Group C: Group C (routine nutrition advice and oral chlorhexidine decontamination, RN&CD)Experimental treatment 1 intervention
Group D: Group D (routine nutrition advice and routine oral care, RN&RC)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

postoperative pulmonary complications

composite outcome of postoperative pulmonary complications, including pneumonia, atelectasis, pneumothorax, bronchospasm, pleural effusion, hypoxemia, acute respiratory failure, prolonged mechanical ventilation, unplanned re-intubation,etc.

Time frame
within 7 days after surgery

Secondary outcomes

1

postoperative pneumonia

defined according to the US Centers for Disease Control Definition

Time frame
within 7days and 30 days after surgery
2

postoperative pulmonary complications

composite outcome of postoperative pulmonary complications, including pneumonia, atelectasis, pneumothorax, bronchospasm, pleural effusion, hypoxemia, acute respiratory failure, prolonged mechanical ventilation, unplanned re-intubation,etc.

Time frame
within 30 days after surgery
3

postoperative infectious complications

composite outcome including surgical site infection, respiratory infection, urinary tract infection, intra-abdominal infection, blood stream infection, etc.

Time frame
within 7days and 30 days after surgery
4

postoperative complications

defined using comprehensive complication index

Time frame
within 7days and 30 days after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
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