FeNO Observation Study in ICU Patients With ARS

An Observational Study of Fractional Exhaled Nitric Oxide Concentration in Patients With Advanced Respiratory Support

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.

Study Overview

• Status: Recruiting
• Conditions: Compare the Concentration of Exhaled Nitric Oxide in Patients With Different Severity of RF
• Intervention / Treatment: Other: FeNO Observation

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Huan Wang, Master; Phone Number: 13472735075; Email: wang.huan@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Shanghai Zhongshan Hospital
      • Contact: Huan Wang, Master; Phone Number: 13472735075; Email: wang.huan@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

ICU patients with advanced respiratory support

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FeNO concentration	Exhaled nitric oxide concentration of patients with different severity of respiratory failure in ICU	1.5 year

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Study Director: Ming Zhong, Doctor, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 6, 2024
• First Submitted That Met QC Criteria: November 6, 2024
• First Posted (Estimated): November 8, 2024

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 6, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ShanghaiZhongshanICU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No