Back to resultsPerioperative Oral Decontamination and ImmunoNuTrition (POINT) in Elderly (POINT)
Primary Purpose
Postoperative Complications, Pulmonary Complication
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
immunonutrition supplement of ORAL IMPACT™
oral chlorhexidine decontamination
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Complications focused on measuring immunonutrition, oral decontamination, postoperative pulmonary complications
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- The Second Hospital of Hebei Medical UniversityRecruiting
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
Group A (immunonutrition and oral chlorhexidine decontamination, IN&CD)
Group B (immunonutrition and routine oral care, IN&RC)
Group C (routine nutrition advice and oral chlorhexidine decontamination, RN&CD)
Group D (routine nutrition advice and routine oral care, RN&RC)
Arm Description
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
postoperative pneumonia
defined according to the US Centers for Disease Control Definition
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.
postoperative infectious complications
composite outcome including surgical site infection, respiratory infection, urinary tract infection, intra-abdominal infection, blood stream infection, etc.
postoperative complications
defined using comprehensive complication index
postoperative recovery
assessed by 15-item quality of recovery questionnaire and WHO disability assessment schedule 2.0
hospitalization expenses
total expense during the hospital stay
length of hospital stay
days of in hospital stay
Full Information
NCT ID
NCT05971810
First Posted
July 21, 2023
Last Updated
September 3, 2023
Sponsor
Peking Union Medical College Hospital
Collaborators
Fujian Provincial Hospital, The Second Hospital of Hebei Medical University, Shenzhen Qianhai Shekou Free Trade Zone Hospital, Ningbo No.2 Hospital, Peking University International Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05971810
Brief Title
Perioperative Oral Decontamination and ImmunoNuTrition (POINT) in Elderly
Acronym
POINT
Official Title
Perioperative Oral Decontamination and ImmunoNuTrition (POINT) on Postoperative Pulmonary Complications in Elderly: a Multicenter Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2023 (Actual)
Primary Completion Date
August 1, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
Fujian Provincial Hospital, The Second Hospital of Hebei Medical University, Shenzhen Qianhai Shekou Free Trade Zone Hospital, Ningbo No.2 Hospital, Peking University International Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications, Pulmonary Complication
Keywords
immunonutrition, oral decontamination, postoperative pulmonary complications
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
592 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A (immunonutrition and oral chlorhexidine decontamination, IN&CD)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B (immunonutrition and routine oral care, IN&RC)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group C (routine nutrition advice and oral chlorhexidine decontamination, RN&CD)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group D (routine nutrition advice and routine oral care, RN&RC)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
immunonutrition supplement of ORAL IMPACT™
Intervention Description
For intervention group, patients will take immunonutrition supplement after recruitment until the day before surgery.
Intervention Type
Other
Intervention Name(s)
oral chlorhexidine decontamination
Intervention Description
For intervention group, patients will use 0.12% chlorhexidine for oral rinse twice daily from the day before surgery until 3 days after surgery.
Primary Outcome Measure Information:
Title
postoperative pulmonary complications
Description
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 Outcome Measure Information:
Title
postoperative pneumonia
Description
defined according to the US Centers for Disease Control Definition
Time Frame
within 7days and 30 days after surgery
Title
postoperative pulmonary complications
Description
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
Title
postoperative infectious complications
Description
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
Title
postoperative complications
Description
defined using comprehensive complication index
Time Frame
within 7days and 30 days after surgery
Title
postoperative recovery
Description
assessed by 15-item quality of recovery questionnaire and WHO disability assessment schedule 2.0
Time Frame
within 7days and 30 days after surgery
Title
hospitalization expenses
Description
total expense during the hospital stay
Time Frame
upon hospital discharge, typically 1-2 weeks
Title
length of hospital stay
Description
days of in hospital stay
Time Frame
upon hospital discharge，typically 1-2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lu Che, Dr
Phone
69152020
Email
tracymaobao@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuguang Huang, Dr
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chaolei Liu
Email
verna521@163.com
Facility Name
Peking Union Medical College Hospital
City
Peking
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lu Che, M.D
Email
tracymaobao@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Perioperative Oral Decontamination and ImmunoNuTrition (POINT) in Elderly
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