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Recruiting NCT06393179

Epidemiology and Treatment Strategy of Open Respiratory Phenotype in Critically Ill Patients

No phase Interventional Mechanical Ventilation Pressure High Critical Illness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: pressure-volume curve with a low-flow insufflation of 5 L/min.
Who it may be relevant to
Registry conditions: Mechanical Ventilation Pressure High, Critical Illness. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Monitoring airway pressure is essential for patients with mechanical ventilation. However, static airway pressure does not reflect alveolar pressure at all. Airway pressure is supposed to completely interrupt the communication between proximal airway opening and the distal alveolar and/or small airway structures. In this condition, some alveoli may still be inflated but do not communicate with proximal airways and auto-PEEP will give a biased estimated of mean alveolar pressure. To be note, distinguishing the airway closure and alveolar collapse can be challenging at times. The quasi-static PV curve is a useful bedside tool to set mechanical ventilation, which may help us to identify the airway closure and alveolar collapse. Meanwhile, the quasi-static PV curve can only reflects a global behaviour of the lung, while EIT may be a useful tool to assess the regional information on airway closure and alveolar collapse.

Interventions

  • Other pressure-volume curve with a low-flow insufflation of 5 L/min
    The patient undergoes a pressure-volume curve with a low-flow insufflation of 5 L/min while in a state of analgesia, sedation, and absence of spontaneous breathing.

Primary outcome measures

  • the rate of airway closure and alveolar collapse [Time frame: up to 24 hours]
  • Phenotype of respiratory open pressure [Time frame: up to 24 hours]
Secondary outcome measures (1)
  • respiratory system compliance [Time frame: up to 24 hours]

Eligibility criteria

Inclusion criteria

  • Adult patients undergoing controlled mechanical ventilation
  • The duration of endotracheal intubation < 48 hrs

Exclusion criteria

  • Severe hemodynamic instability
  • Severe chronic lung disease requiring long-term home oxygen therapy
  • Patients without analgesic sedation
  • Decline to participate in the study
  • Refusal to sign informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast Univ — Nanjing

Identifiers

NCT: NCT06393179 · OPEN-RESPIRATORY

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗