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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06393179
• Other study ID #: OPEN-RESPIRATORY
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 30, 2024
• Est. completion date: August 30, 2024

Study information

• Verified date: April 2024
• Source: Southeast University, China
• Contact: ling liu, phD
• Phone: 15901599659
• Email: liulingdoctor[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Mechanical Ventilation Pressure High

Intervention

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.

Locations

Country	Name	City	State
China	Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of airway closure and alveolar collapse	airway closure and alveolar collapse are monitored by PV curve with a low-flow insufflation of 5 L/min	up to 24 hours
Primary	Phenotype of respiratory open pressure	According to the characteristics of the low inflation point of PV curve, the respiratory open pressure phenotype was constructed	up to 24 hours
Secondary	respiratory system compliance	Respiratory system compliance is calculated as the ratio of tidal volume to the difference between plateau pressure and positive end-expiratory pressure.	up to 24 hours