Investigation of the effect of positive pressure ventilation before extubation using Electrical impedance tomography

UMIN ID: UMIN000055489

Registered date:11/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Intubated patient
• Date of first enrollment: 2023/06/10
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

1) Considering weaning from the ventilator, patients scheduled to undergo SBT will be fitted with intraesophageal pressure monitor and EIT for monitoring prior to SBT (Monitoring 1). 2) Patients in both groups will undergo SBT (CPAP+PS mode, PSV 5 cmH2O, PEEP 5 cmH2O) for 30 minutes and undergo intraesophageal pressure + EIT monitoring. (Monitoring 2) 3) In Group A, positive pressure ventilation (CPAP+PS mode, PSV 15 cmH2O, PEEP 10 cmH2O) is performed for 30 minutes, followed by 30 minutes of management in ATC mode. In both cases, intraesophageal pressure + EIT monitoring will be performed. (Monitoring 3) 4) The SBT setting is returned again and continued for 30 minutes, and intraesophageal pressure + EIT monitoring is performed. (Monitoring 4) 5) In Group A, ATC mode is performed for 30 minutes, and intraesophageal pressure + EIT monitoring is performed. (Monitoring 5).
1) Considering weaning from the ventilator, patients scheduled to undergo SBT will be fitted with an intraesophageal pressure monitor and EIT and monitored before SBT is performed (Monitoring 1). 2) Perform SBT (CPAP+PS mode, PSV 5 cmH2O, PEEP 5 cmH2O) on the patient for 30 minutes and perform intraesophageal pressure + EIT monitoring. (Monitoring 2) 3) Group B will perform ATC mode for 30 minutes. Intraesophageal pressure + EIT monitoring will be performed. (Monitoring 3) 4) The SBT setting is returned again and continued for 30 minutes, and intraesophageal pressure + EIT monitoring is performed. (Monitoring 4) 5) In Group B, positive pressure ventilation (CPAP + PS mode, PSV 15 cmH2O, PEEP 10 cmH2O) is performed for 30 minutes, followed by 30 minutes of management in ATC mode. In both cases, intraesophageal pressure + EIT monitoring will be performed. (Monitoring 5).

Outcome(s)

• Primary Outcome: work of breathing (pressure time product with esophageal pressure), transpulmonary pressure (inspiratory transpulmonary pressure, delta transpulmonary pressure), oxygenation after extubation, end-expiratory lung volume (end-expiratory impedance), ventilation distribution (tidal impedance variation), and pendelluft phenomenon.
• Secondary Outcome: Successful weaning from ventilator Respiratory failure and reintubation rate at 72 hours after extubation Respiratory complications (pneumonia, hypoxemia, upper airway obstruction, bronchospasm, etc.) for 5 days after extubation or until ICU discharge

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: Patients who cannot maintain airway patency (impaired consciousness, weak cough reflex, high airway secretions, positive cufflink test, etc.), severely obese (BMI>35 kg/m2), patients with chest trauma or other difficulties in EIT monitoring, post esophageal surgery, etc.

Related Information

• Primary Sponsor: The University of Tokushima Hospital Department of Emergency and Intensive Care Medicine
• Source(s) of Monetary Support: none