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OpenTrials
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NCT Number: NCT06393179

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University

Nanjing, Jiangsu, 210000, China

Location status: Recruiting

Location contact

ling liu, phD

CONTACT

[email protected]

86-25-83272201

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pressure-volume curve with a low-flow insufflation of 5 L/min

Other

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 outcomes

  1. the rate of airway closure and alveolar collapse

    Time frame: up to 24 hours

    airway closure and alveolar collapse are monitored by PV curve with a low-flow insufflation of 5 L/min

  2. Phenotype of respiratory open pressure

    Time frame: up to 24 hours

    According to the characteristics of the low inflation point of PV curve, the respiratory open pressure phenotype was constructed

Secondary outcomes

  1. respiratory system compliance

    Time frame: up to 24 hours

    Respiratory system compliance is calculated as the ratio of tidal volume to the difference between plateau pressure and positive end-expiratory pressure.

Study contacts

Contact information is provided by the study sponsor or research team.

ling liu, phD

CONTACT

[email protected]

15901599659

xueyan yuan, phD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 1, 2024
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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