Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06430554
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-05-21
Brief Title:
Personalized Ventilation Based on Ventilation-perfusion Mismatch and Lung Recruitability
Sponsor:
Zhongda Hospital
Organization:
Zhongda Hospital
Study Overview
Official Title:
Personalized Ventilatory Strategy Based on Ventilation-perfusion Mismatch and Lung Recruitability in Moderate-to-severe ARDS Patients
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This observational study will explore the effects of PEEP and position on regional lung ventilation-perfusion mismatch by electrical impedance tomography EIT in moderate-to-severe ARDS patients with different lung recruitability
Detailed Description:
Acute respiratory distress syndrome ARDS is characterized by impaired ventilation-perfusion matching which not only indicates the severity of the condition but also contributes to ventilation-induced lung injury Higher positive end-expiratory pressure PEEP and prone position could improve ventilation-perfusion mismatch by recruiting collapsed lungs and facilitating more homogeneous ventilation but these benefits might depend on lung recruitability The present study aims to elucidate the regional effect of PEEPlow and high and body positionsupine and prone on the ventilation-perfusion matching Also endeavors to establish correlations between alterations in ventilation-perfusion matching patterns and the inherent lung recruitability
Participants will be deeply sedated and paralyzed ventilated in volume-controlled with protective ventilation tidal volume6-8 mLKg of predicted body weight and respiratory rate set to obtain normal pH Then the patients will be sequentially assigned to each of four conditions as follows
Low PEEP supine position High PEEP supine position Low PEEP prone position High PEEP prone position High PEEP and low PEEP is defined as 15 cmH2O and 5 cmH2O or airway opening pressure either of which was higher respectively Each measurement eg arterial blood gas analysis respiratory parameters hemodynamics EIT measurements will be performed at least 15 minutes after changing ventilator settings and at least 1 hour after changing body positions The timing of turning patients from supine to prone position is determined by the clinical team
To assess lung recruitability a single-breath derecruitment maneuver will be performed by changing PEEP 15 to 5 cmH2O or airway opening pressure either of which was higher in supine position Patients with recruitment-inflation ratio over the median value are defined as high recruiters
EIT data will be collected by standard device Infinity C500 Drager Germany with a sample rate of 50 Hz The EIT belt will be placed directly below the armpits between the third and fifth intercostal spaces This positioning of the EIT belt will be maintained consistently during both supine and prone positions A bolus of 10 ml 5 NaCl will be injected during a respiratory pause 8 s through the central venous catheter to assess lung ventilation and perfusion distributions The primary endpoint is EIT-based ventilation-perfusion matching VQ match
Participants will be deeply sedated and paralyzed ventilated in volume-controlled with protective ventilation tidal volume6-8 mLKg of predicted body weight and respiratory rate set to obtain normal pH Then the patients will be sequentially assigned to each of four conditions as follows
Low PEEP supine position High PEEP supine position Low PEEP prone position High PEEP prone position High PEEP and low PEEP is defined as 15 cmH2O and 5 cmH2O or airway opening pressure either of which was higher respectively Each measurement eg arterial blood gas analysis respiratory parameters hemodynamics EIT measurements will be performed at least 15 minutes after changing ventilator settings and at least 1 hour after changing body positions The timing of turning patients from supine to prone position is determined by the clinical team
To assess lung recruitability a single-breath derecruitment maneuver will be performed by changing PEEP 15 to 5 cmH2O or airway opening pressure either of which was higher in supine position Patients with recruitment-inflation ratio over the median value are defined as high recruiters
EIT data will be collected by standard device Infinity C500 Drager Germany with a sample rate of 50 Hz The EIT belt will be placed directly below the armpits between the third and fifth intercostal spaces This positioning of the EIT belt will be maintained consistently during both supine and prone positions A bolus of 10 ml 5 NaCl will be injected during a respiratory pause 8 s through the central venous catheter to assess lung ventilation and perfusion distributions The primary endpoint is EIT-based ventilation-perfusion matching VQ match
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None