PICSNCT07002710
Impact of Persistent Inflammation-Immunosuppression-Catabolism Syndrome (PICS) on the Respiratory Physiology in Patients With Prolonged Mechanical Ventilation
An observational study of PICS, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Past research on PICS has mainly focused on the predictability and prognosis of PICS occurrence in ICU patients. Still, there is currently insufficient research on the role of PICS in the care setting of patients who have stabilized and are transferred to respiratory care units such as Respiratory Care Centers (RCCs)… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- PICS
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Mar 2025to 31 Dec 2026
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential candidates for screening are adult patients transferred from RCC who are still on ventilators and will undergo screening assessment by researchers.
Who may be able to join
- Patients are still receiving ventilator support when transferred to the ward where the study is conducted.
- Use the respirator continuously for at least 10 days.
- Vital signs are stable: blood pressure systolic blood pressure is not lower than 70 mmHg; heartbeat is not lower than 50/min and not higher than 160/min; respiratory rate is not higher than 50/min.
- When using respirator support, the oxygen concentration should not exceed 60%.
Who cannot join
- ．At least one of the following conditions occurs: 1. Pregnancy. 2. The patient refuses to undergo weaning from the respirator training. 3. The patient has no ability to drive spontaneous breathing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jih-Shuin Jerng, MD, PhD, Principal Investigator contact
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Jih-Shuin Jerng, MD, PhD, +886-2-23123456 ext. Ext. 263532, jsjerng@ntu.edu.tw
About this study
Past research on PICS has mainly focused on the predictability and prognosis of PICS occurrence in ICU patients. Still, there is currently insufficient research on the role of PICS in the care setting of patients who have stabilized and are transferred to respiratory care units such as Respiratory Care Centers (RCCs) for weaning attempts. To understand the impact of PICS on the respiratory physiology of patients undergoing weaning from prolonged mechanical ventilation, investigators propose a one-year research plan
Read the detailed description
Past research on PICS has mainly focused on the predictability and prognosis of PICS occurrence in ICU patients. Still, there is currently insufficient research on the role of PICS in the care setting of patients who have stabilized and are transferred to respiratory care units such as Respiratory Care Centers (RCCs) for weaning attempts. To understand the impact of PICS on the respiratory physiology of patients undergoing weaning from prolonged mechanical ventilation, investigators propose a one-year research plan with the hypothesis that PICS endotype patients in the RCC setting are more likely to develop alveolar collapse during weaning trials, leading to decreased oxygenation function, increased respiratory burden, and potentially more lung injury from repeated alveolar collapse and reopening. Investigators plan to enroll 60 PMV patients admitted to the RCC, perform laboratory analyses to categorize patients as PICS endotype or other types, and then collect clinical data, respiratory physiology data, and biomarkers during weaning trials, such as changes in oxygenation, respiratory work and energy expenditure, infection occurrence, diaphragm ultrasound, esophageal pressure measurements, electrical impedance tomography, and inflammatory biomarkers. The expected research outcomes include the prevalence of PICS in stable PMV patients in the RCC setting and the differences in respiratory physiology and weaning outcomes between PICS and non-PICS patients, which could inform differentiated or personalized weaning strategies in the future.
- Conditions
- PICS
- Keywords
- PICS
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Persistent Inflammation-Immunosuppression-Catabolism Syndrome (PICS) on the Respiratory Physiology in Patients with Prolonged Mechanical Ventilation
To understand whether weaning training strategies for PICS and non-PICS patients may have different considerations when patients undergo spontaneous breathing testing.
Measured: January 1st,2025 to December 31st,2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start18 Mar 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PICSStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07002710
- Sponsor's protocol ID
- 202407047RINE
- Status last verified
- Nov 2024
- First submitted
- 26 Dec 2024
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Persistent Inflammation-Immunosuppression-Catabolism Syndrome (PICS) on the Respiratory Physiology in Patients With Prolonged Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT07002710
- Acronym / sponsor ID
- 202407047RINE
- Conditions
- PICS
- Keywords
- PICS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Jun 2025 (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.
Past research on PICS has mainly focused on the predictability and prognosis of PICS occurrence in ICU patients. Still, there is currently insufficient research on the role of PICS in the care setting of patients who have stabilized and are transferred to respiratory care units such as Respiratory Care Centers (RCCs) for weaning attempts. To understand the impact of PICS on the respiratory physiology of patients undergoing weaning from prolonged mechanical ventilation, investigators propose a one-year research plan
Detailed description
Past research on PICS has mainly focused on the predictability and prognosis of PICS occurrence in ICU patients. Still, there is currently insufficient research on the role of PICS in the care setting of patients who have stabilized and are transferred to respiratory care units such as Respiratory Care Centers (RCCs) for weaning attempts. To understand the impact of PICS on the respiratory physiology of patients undergoing weaning from prolonged mechanical ventilation, investigators propose a one-year research plan with the hypothesis that PICS endotype patients in the RCC setting are more likely to develop alveolar collapse during weaning trials, leading to decreased oxygenation function, increased respiratory burden, and potentially more lung injury from repeated alveolar collapse and reopening. Investigators plan to enroll 60 PMV patients admitted to the RCC, perform laboratory analyses to categorize patients as PICS endotype or other types, and then collect clinical data, respiratory physiology data, and biomarkers during weaning trials, such as changes in oxygenation, respiratory work and energy expenditure, infection occurrence, diaphragm ultrasound, esophageal pressure measurements, electrical impedance tomography, and inflammatory biomarkers. The expected research outcomes include the prevalence of PICS in stable PMV patients in the RCC setting and the differences in respiratory physiology and weaning outcomes between PICS and non-PICS patients, which could inform differentiated or personalized weaning strategies in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential candidates for screening are adult patients transferred from RCC who are still on ventilators and will undergo screening assessment by researchers.
Key inclusion criteria (4 listed)
- Patients are still receiving ventilator support when transferred to the ward where the study is conducted.
- Use the respirator continuously for at least 10 days.
- Vital signs are stable: blood pressure systolic blood pressure is not lower than 70 mmHg; heartbeat is not lower than 50/min and not higher than 160/min; respiratory rate is not higher than 50/min.
- When using respirator support, the oxygen concentration should not exceed 60%.
Key exclusion criteria (1 listed)
- ．At least one of the following conditions occurs: 1. Pregnancy. 2. The patient refuses to undergo weaning from the respirator training. 3. The patient has no ability to drive spontaneous breathing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Impact of Persistent Inflammation-Immunosuppression-Catabolism Syndrome (PICS) on the Respiratory Physiology in Patients with Prolonged Mechanical Ventilation
Time frame: January 1st,2025 to December 31st,2026
To understand whether weaning training strategies for PICS and non-PICS patients may have different considerations when patients undergo spontaneous breathing testing.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
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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.
Jih-Shuin Jerng, MD, PhD, Principal Investigator contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PICS, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jih-Shuin Jerng, MD, PhD, Principal Investigator (+886-2-23123456 ext. Ext. 263532, jsjerng@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Persistent Inflammation-Immunosuppression-Catabolism Syndrome (PICS) on the Respiratory Physiology in Patients with Prolonged Mechanical Ventilation (time frame: January 1st,2025 to December 31st,2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2025.