FeNO Observation Study in ICU Patients With ARS

Recruiting

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

• Registration Number: NCT06680895
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief 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. 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

Not available

Study Timeline

• Study Start: 2024-07-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-06
• Study First Submitted QC: 2024-11-06
• Last Update Submitted: 2024-11-06
• Study First Posted: 2024-11-08
• Last Update Posted: 2024-11-08
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
FeNO concentration	1.5 year	Exhaled nitric oxide concentration of patients with different severity of respiratory failure in ICU

Trial Locations

Locations (1)

Shanghai Zhongshan hospital; 🇨🇳 Shanghai, Shanghai, China