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

NCT06393179 | Recruiting

• 1 other identifier: OPEN-RESPIRATORY
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation Pressure High; Critical Illness

Keywords

mechanical ventilation; airway closure; alveolar collapse

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• respiratory system compliance

  up to 24 hours

Study Arms (1)

P-V curve group

EXPERIMENTAL

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.

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

Interventions

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.

P-V curve group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• ling liu

  Zhongda Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ling liu, phD

CONTACT

15901599659; liulingdoctor@126.com

xueyan yuan, phD

CONTACT

18826401594@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Intensive Care Unit, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: April 27, 2024
• First Posted: May 1, 2024
• Study Start: May 30, 2024
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: August 16, 2024

Record last verified: 2024-08

Locations

CN (1)