Perioperative Oral Decontamination and ImmunoNuTrition (POINT) in Elderly

Postoperative Complications Clinical Trial

— POINT  

Official title:

Perioperative Oral Decontamination and ImmunoNuTrition (POINT) on Postoperative Pulmonary Complications in Elderly: a Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05971810
• Other study ID #: I-23PJ953
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2023
• Est. completion date: September 1, 2025

Study information

• Verified date: July 2023
• Source: Peking Union Medical College Hospital
• Contact: Lu Che, Dr
• Phone: 69152020
• Email: tracymaobao[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This study is a prospective, multicenter, two-by-two factorial randomized controlled trial evaluating the efficacy of immunonutrition supplementation and oral chlorhexidine decontamination. Patients aged 65 years and older who are scheduled for elective non-cardiac surgeries will be recruited. Participants will be excluded if they have contraindication to the intervention. The patients will be randomized into four groups in 1:1:1:1 ratio (oral decontamination vs routine oral care, immunonutrition supplementation vs routine nutrition advice). The primary outcome is the incidence of postoperative pulmonary complications within 7 days after surgery. Secondary outcomes include incidence of pneumonia, infectious complications, comprehensive complication index, postoperative functional recovery, length of hospital stay and hospital expense.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 592
• Est. completion date: September 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. age=65 years;

2. undergoing major non-cardiac surgery;

3. scheduled for general anesthesia and endotracheal intubation;

4. American Society of Anesthesiologists (ASA) physical status classification I-IV;

5. with intermediate to high risk of respiratory complications assessed by Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) score;

6. informed consent obtained.

Exclusion Criteria:

1. emergency surgery;

2. preoperative pneumonia;

3. allergic to chlorhexidine;

4. severe hepatic/renal dysfunction, incapable of oral feeding, with autoimmune diseases, taking immunosuppressant or immunoregulation medications, or with other contraindication to immunonutrition supplementation;

5. expected intervention of immunonutrition<3 days.

Related Conditions & MeSH terms

• Postoperative Complications
• Pulmonary Complication

Intervention

Dietary Supplement:
• immunonutrition supplement of ORAL IMPACT™
For intervention group, patients will take immunonutrition supplement after recruitment until the day before surgery.

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

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Peking
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (6)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Fujian Provincial Hospital, Ningbo No.2 Hospital, Peking University International Hospital, Shenzhen Qianhai Shekou Free Trade Zone Hospital, The Second Hospital of Hebei Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	within 7 days after surgery
Secondary	postoperative pneumonia	defined according to the US Centers for Disease Control Definition	within 7days and 30 days after surgery
Secondary	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.	within 30 days after surgery
Secondary	postoperative infectious complications	composite outcome including surgical site infection, respiratory infection, urinary tract infection, intra-abdominal infection, blood stream infection, etc.	within 7days and 30 days after surgery
Secondary	postoperative complications	defined using comprehensive complication index	within 7days and 30 days after surgery
Secondary	postoperative recovery	assessed by 15-item quality of recovery questionnaire and WHO disability assessment schedule 2.0	within 7days and 30 days after surgery
Secondary	hospitalization expenses	total expense during the hospital stay	upon hospital discharge, typically 1-2 weeks
Secondary	length of hospital stay	days of in hospital stay	upon hospital discharge,typically 1-2 weeks