FeNO Observation Study in ICU Patients With ARS

NCT ID: NCT06680895

Last Updated: 2024-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-12-31

Brief Summary

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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. The relationship and differences between pulmonary ventilation blood flow levels in patients with different exhaled NO concentrations;
3. Reactivity of patients with different exhaled NO concentrations to inhaled nitric oxide therapy and the relationship between them.

Detailed Description

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Conditions

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Compare the Concentration of Exhaled Nitric Oxide in Patients With Different Severity of RF

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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FeNO Observation

FeNO was observed and measured among patients with advanced respiratory support

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Adult patients (≥18 years of age) with mechanical ventilation or advanced respiratory support in the ICU, regardless of gender;
2. The expected mechanical ventilation time of tracheal intubation is more than 24 hours;
3. 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;
4. Agree to participate in this experiment and sign the informed consent.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ming Zhong, Doctor

Role: STUDY_DIRECTOR

Fudan University

Locations

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Shanghai Zhongshan hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Huan Wang, Master

Role: CONTACT

13472735075

Facility Contacts

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Huan Wang, Master

Role: primary

13472735075

Other Identifiers

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ShanghaiZhongshanICU

Identifier Type: -

Identifier Source: org_study_id

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