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

Not Applicable

Recruiting

• Conditions: Mechanical Ventilation Pressure High; Critical Illness
• Interventions: Other: pressure-volume curve with a low-flow insufflation of 5 L/min

• Registration Number: NCT06393179
• Lead Sponsor: Southeast University, China

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-27
• Study First Submitted QC: 2024-04-27
• Study First Posted: 2024-05-01
• Study Start: 2024-05-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-16
• Primary Completion: 2024-08-30
• Study Completion: 2024-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
P-V curve group	pressure-volume curve with a low-flow insufflation of 5 L/min	Enrolled patients will receive a PV curve with a low-flow insufflation of 5 L/min starting from 0 cmH2O to a maximal airway pressure corresponding to the plateau pressure.

Primary Outcome Measures

Name	Time	Method
the rate of airway closure and alveolar collapse	up to 24 hours	airway closure and alveolar collapse are monitored by PV curve with a low-flow insufflation of 5 L/min
Phenotype of respiratory open pressure	up to 24 hours	According to the characteristics of the low inflation point of PV curve, the respiratory open pressure phenotype was constructed

Secondary Outcome Measures

Name	Time	Method
respiratory system compliance	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.

Trial Locations

Locations (1)

Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University; 🇨🇳 Nanjing, Jiangsu, China