Perioperative Oral Decontamination and ImmunoNuTrition (POINT) in Elderly

NCT05971810 | Recruiting DMC

• 1 other identifier: I-23PJ953
• Study Type: interventional
• Target: 592
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Postoperative Complications; Pulmonary Complication

Keywords

immunonutrition; oral decontamination; postoperative pulmonary complications

Outcome Measures

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.

  within 7 days after surgery

Secondary Outcomes (7)

• postoperative pneumonia

  within 7days and 30 days after surgery

• postoperative pulmonary complications

  within 30 days after surgery

• postoperative infectious complications

  within 7days and 30 days after surgery

• postoperative complications

  within 7days and 30 days after surgery

• postoperative recovery

  within 7days and 30 days after surgery

Study Arms (4)

Group A (immunonutrition and oral chlorhexidine decontamination, IN&CD)

EXPERIMENTAL

Patients in this group will receive immunonutrition supplementation from the day of allocation at the preoperative anesthesia clinic until the day before surgery (usually 1-3 weeks), which is oral intake of ORAL IMPACT™ 2 servings per day. Patients will also receive oral chlorhexidine decontamination using 0.12% chlorhexidine oral rinse twice daily from the day before surgery until postoperative day 3.

Dietary Supplement: immunonutrition supplement of ORAL IMPACT™; Other: oral chlorhexidine decontamination

Group B (immunonutrition and routine oral care, IN&RC)

EXPERIMENTAL

Patients in this group will receive immunonutrition supplementation from the day of allocation at the preoperative anesthesia clinic until the day before surgery (usually 1-3 weeks), which is oral intake of ORAL IMPACT™ 2 servings per day. For oral health care, they will receive routine oral care which is routine toothbrushing twice daily.

Dietary Supplement: immunonutrition supplement of ORAL IMPACT™

Group C (routine nutrition advice and oral chlorhexidine decontamination, RN&CD)

EXPERIMENTAL

Patients in this group will be advised to follow a standard nutrition advice with a total intake of 30kcal/kg/d and protein intake of 1.2g/kg/d. They will also receive oral chlorhexidine decontamination using 0.12% chlorhexidine oral rinse twice daily from the day before surgery until postoperative day 3.

Other: oral chlorhexidine decontamination

Group D (routine nutrition advice and routine oral care, RN&RC)

NO INTERVENTION

Patients in this group will be advised to follow a standard nutrition advice with a total intake of 30kcal/kg/d and protein intake of 1.2g/kg/d. They will also receive routine oral care which is routine toothbrushing twice daily.

Interventions

immunonutrition supplement of ORAL IMPACT™ DIETARY_SUPPLEMENT

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

Group A (immunonutrition and oral chlorhexidine decontamination, IN&CD); Group B (immunonutrition and routine oral care, IN&RC)

oral chlorhexidine decontamination OTHER

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

Group A (immunonutrition and oral chlorhexidine decontamination, IN&CD); Group C (routine nutrition advice and oral chlorhexidine decontamination, RN&CD)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;
• expected intervention of immunonutrition\<3 days.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Fujian Provincial Hospital: collaborator
• The Second Hospital of Hebei Medical University: collaborator
• Shenzhen Qianhai Shekou Free Trade Zone Hospital: collaborator
• Ningbo No.2 Hospital: collaborator
• Peking University International Hospital: collaborator
• Guizhou Provincial People's Hospital: collaborator

Study Sites (2)

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

RECRUITING

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Related Publications (1)

• Yu J, Che L, Zhu Q, Xu L, Fu J, Zhang Y, You M, Zheng X, Liu C, Huang L, Wang W, Yao L, Fan G, Chen J, Zhang J, Huang Y. Perioperative Oral decontamination and ImmunoNuTrition (POINT) to prevent postoperative pulmonary complications in elderly patients scheduled for elective non-cardiac surgeries: protocol for a multicentre, randomised controlled trial. BMJ Open. 2025 May 14;15(5):e092068. doi: 10.1136/bmjopen-2024-092068.

  PMID: 40374210 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yuguang Huang, Dr

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lu Che, Dr

CONTACT

69152020; tracymaobao@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 2, 2023
• Study Start: August 23, 2023
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: January 28, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: 6 months after publication of study results.
• Access Criteria: Data will be available from the corresponding author upon reasonable request.

Locations

CN (2)