Postoperative ComplicationsPOINTNCT05971810
Perioperative Oral Decontamination and ImmunoNuTrition (POINT) in Elderly
A study testing immunonutrition supplement of ORAL IMPACT™ and oral chlorhexidine decontamination in people with Postoperative Complications and Pulmonary Complication, run by Peking Union Medical College Hospital at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Complications, Pulmonary Complication
- What is being tested?
- immunonutrition supplement of ORAL IMPACT™ and oral chlorhexidine decontamination
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 592 participants
- Where
- 2 sitesChina
- Study dates
- 23 Aug 2023to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Lu Che, M.D, tracymaobao@126.com
- Recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei
Chaolei Liu, verna521@163.com
About this study
Official title: Perioperative Oral Decontamination and ImmunoNuTrition (POINT) on Postoperative Pulmonary Complications in Elderly: a Multicenter Randomized Controlled 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.
Read the 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.
- Being tested
- immunonutrition supplement of ORAL IMPACT™, oral chlorhexidine decontamination
- Keywords
- immunonutrition, oral decontamination, postoperative pulmonary complications
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunonutrition supplement of ORAL IMPACT™Dietary supplement
For intervention group, patients will take immunonutrition supplement after recruitment until the day before surgery.
oral chlorhexidine decontaminationOther
For intervention group, patients will use 0.12% chlorhexidine for oral rinse twice daily from the day before surgery until 3 days after surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 7 days after surgery
Secondary outcomes (7)
postoperative pneumonia
defined according to the US Centers for Disease Control Definition
Measured: within 7days and 30 days after surgery
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.
Measured: within 30 days after surgery
postoperative infectious complications
composite outcome including surgical site infection, respiratory infection, urinary tract infection, intra-abdominal infection, blood stream infection, etc.
Measured: within 7days and 30 days after surgery
postoperative complications
defined using comprehensive complication index
Measured: within 7days and 30 days after surgery
postoperative recovery
assessed by 15-item quality of recovery questionnaire and WHO disability assessment schedule 2.0
Measured: within 7days and 30 days after surgery
hospitalization expenses
total expense during the hospital stay
Measured: upon hospital discharge, typically 1-2 weeks
length of hospital stay
days of in hospital stay
Measured: upon hospital discharge，typically 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start23 Aug 2023
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 592 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fujian Provincial Hospital, The Second Hospital of Hebei Medical University, Shenzhen Nanshan District Shekou People's Hospital, Ningbo No.2 Hospital, Peking University International Hospital, Guizhou Provincial People's Hospital
- Responsible party
- Sponsor
- Investigators
- Yuguang Huang, Dr, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971810
- Sponsor's protocol ID
- I-23PJ953
- Acronym
- POINT
- Status last verified
- Jul 2024
- First submitted
- 21 Jul 2023
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be available from the corresponding author upon reasonable request.
Publications
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.
PubMed 40374210
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Oral Decontamination and ImmunoNuTrition (POINT) on Postoperative Pulmonary Complications in Elderly: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05971810
- Acronym / sponsor ID
- POINT / I-23PJ953
- Keywords
- immunonutrition, oral decontamination, postoperative pulmonary complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 592 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Fujian Provincial Hospital, The Second Hospital of Hebei Medical University, Shenzhen Nanshan District Shekou People's Hospital, Ningbo No.2 Hospital, Peking University International Hospital, Guizhou Provincial People's Hospital
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A (immunonutrition and oral chlorhexidine decontamination, IN&CD) | Experimental | Dietary Supplement: immunonutrition supplement of ORAL IMPACT™, Other: oral chlorhexidine decontaminationPatients 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. |
| Group B (immunonutrition and routine oral care, IN&RC) | Experimental | Dietary Supplement: immunonutrition supplement of ORAL IMPACT™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. |
| Group C (routine nutrition advice and oral chlorhexidine decontamination, RN&CD) | Experimental | Other: oral chlorhexidine decontaminationPatients 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. |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immunonutrition supplement of ORAL IMPACT™For intervention group, patients will take immunonutrition supplement after recruitment until the day before surgery. | Dietary supplement | Group A (immunonutrition and oral chlorhexidine decontamination, IN&CD), Group B (immunonutrition and routine oral care, IN&RC) |
| oral chlorhexidine decontaminationFor intervention group, patients will use 0.12% chlorhexidine for oral rinse twice daily from the day before surgery until 3 days after surgery. | Other | Group A (immunonutrition and oral chlorhexidine decontamination, IN&CD), Group C (routine nutrition advice and oral chlorhexidine decontamination, RN&CD) |
Primary outcome
postoperative pulmonary complications
Time frame: within 7 days after surgery
composite outcome of postoperative pulmonary complications, including pneumonia, atelectasis, pneumothorax, bronchospasm, pleural effusion, hypoxemia, acute respiratory failure, prolonged mechanical ventilation, unplanned re-intubation,etc.
7 secondary outcomes
postoperative pneumonia
Time frame: within 7days and 30 days after surgery
postoperative pulmonary complications
Time frame: within 30 days after surgery
postoperative infectious complications
Time frame: within 7days and 30 days after surgery
postoperative complications
Time frame: within 7days and 30 days after surgery
postoperative recovery
Time frame: within 7days and 30 days after surgery
hospitalization expenses
Time frame: upon hospital discharge, typically 1-2 weeks
length of hospital stay
Time frame: upon hospital discharge，typically 1-2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Derived from this study: PubMed 40374210Yu 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.
- Individual participant dataSharing planned: Yes. All data will be available from the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuguang Huang, Dr principal investigator
Peking Union Medical College Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immunonutrition supplement of ORAL IMPACT™ and oral chlorhexidine decontamination in people with Postoperative Complications and Pulmonary Complication, run by Peking Union Medical College Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lu Che, Dr (69152020, tracymaobao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pulmonary complications (time frame: within 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05971810, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.