Compare the Concentration of Exhaled Nitric Oxide in Patients With Different Severity of RFNCT06680895
FeNO Observation Study in ICU Patients With ARS
An observational study of Compare the Concentration of Exhaled Nitric Oxide in Patients With Different Severity of RF, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
1. Main Objective: To compare the concentration of exhaled nitric oxide in patients with different severity of respiratory failure in ICU. 2. Secondary Purpose: 1. To observe the change of nitric oxide concentration in exhaled breath of patients with mechanical ventilation over time; 2. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Compare the Concentration of Exhaled Nitric Oxide in Patients With Different Severity of RF
- What is being tested?
- FeNO Observation
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 31 Dec 2025
- 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 18 to 80 years
- All sexes
- Adult, Older adult
Study population: ICU patients with advanced respiratory support
Who may be able to join
- Adult patients (≥18 years of age) with mechanical ventilation or advanced respiratory support in the ICU, regardless of gender;
- The expected mechanical ventilation time of tracheal intubation is more than 24 hours;
- The initial ventilator Settings of clinical routine were adopted: oxygen fraction (FIO2) = 50%, respiratory rate = 15/min, positive end-expiratory pressure (PEEP) = 5 cmH2O, tidal volume = 6-8 ml/kg ideal body weight (IBW), inspiration-exhalation ratio =1:2;
- Agree to participate in this experiment and sign the informed consent.
Who cannot join
- 1.Use of any NO-containing drugs (such as nitroglycerin), anti-inflammatory drugs, or drugs or means that affect the airway diameter within 6 hours before the first FeNO measurement; 2. Participating in other clinical research projects; 3. Patients deemed unsuitable by the investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Zhongshan hospital
Shanghai, Shanghai Municipality, 200030
Huan Wang, Master, 13472735075, wang.huan@zs-hospital.sh.cn
About this study
Official title: An Observational Study of Fractional Exhaled Nitric Oxide Concentration in Patients With Advanced Respiratory Support
- Main Objective: To compare the concentration of exhaled nitric oxide in patients with different severity of respiratory failure in ICU.
- Secondary Purpose:
- To observe the change of nitric oxide concentration in exhaled breath of patients with mechanical ventilation over time;
- The relationship and differences between pulmonary ventilation blood flow levels in patients with different exhaled NO concentrations;
- Reactivity of patients with different exhaled NO concentrations to inhaled nitric oxide therapy and the relationship between them.
- Conditions
- Compare the Concentration of Exhaled Nitric Oxide in Patients With Different Severity of RF
- Being tested
- FeNO Observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FeNO ObservationOther
FeNO was observed and measured among patients with advanced respiratory support
What is being measured
The primary outcome is the main question the study is designed to answer.
FeNO concentration
Exhaled nitric oxide concentration of patients with different severity of respiratory failure in ICU
Measured: 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start1 Jul 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compare the Concentration of Exhaled Nitric Oxide in Patients With Different Severity of RFStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming Zhong, Doctor, Study director, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680895
- Sponsor's protocol ID
- ShanghaiZhongshanICU
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Fractional Exhaled Nitric Oxide Concentration in Patients With Advanced Respiratory Support
- ClinicalTrials.gov ID
- NCT06680895
- Acronym / sponsor ID
- ShanghaiZhongshanICU
- Conditions
- Compare the Concentration of Exhaled Nitric Oxide in Patients With Different Severity of RF
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Nov 2024 (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.
- Main Objective: To compare the concentration of exhaled nitric oxide in patients with different severity of respiratory failure in ICU.
- Secondary Purpose:
- To observe the change of nitric oxide concentration in exhaled breath of patients with mechanical ventilation over time;
- The relationship and differences between pulmonary ventilation blood flow levels in patients with different exhaled NO concentrations;
- Reactivity of patients with different exhaled NO concentrations to inhaled nitric oxide therapy and the relationship between them.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- ICU patients with advanced respiratory support
Key inclusion criteria (4 listed)
- Adult patients (≥18 years of age) with mechanical ventilation or advanced respiratory support in the ICU, regardless of gender;
- The expected mechanical ventilation time of tracheal intubation is more than 24 hours;
- The initial ventilator Settings of clinical routine were adopted: oxygen fraction (FIO2) = 50%, respiratory rate = 15/min, positive end-expiratory pressure (PEEP) = 5 cmH2O, tidal volume = 6-8 ml/kg ideal body weight (IBW), inspiration-exhalation ratio =1:2;
- Agree to participate in this experiment and sign the informed consent.
Key exclusion criteria (1 listed)
- 1.Use of any NO-containing drugs (such as nitroglycerin), anti-inflammatory drugs, or drugs or means that affect the airway diameter within 6 hours before the first FeNO measurement; 2. Participating in other clinical research projects; 3. Patients deemed unsuitable by the investigators.
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 |
|---|---|---|
| FeNO ObservationFeNO was observed and measured among patients with advanced respiratory support | Other | – |
Primary outcome
FeNO concentration
Time frame: 1.5 year
Exhaled nitric oxide concentration of patients with different severity of respiratory failure in ICU
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 8 Nov 2024.
- Individual participant dataSharing planned: Undecided
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.
Ming Zhong, Doctor study director
Fudan University
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 Compare the Concentration of Exhaled Nitric Oxide in Patients With Different Severity of RF, run by Shanghai Zhongshan Hospital at 1 site 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 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 8 Nov 2024. 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 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?
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 Huan Wang, Master (13472735075, wang.huan@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FeNO concentration (time frame: 1.5 year). 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 8 Nov 2024.