An Evaluation of End-Expiratory Lung Volume and Pulmonary Mechanics With Different PEEP Levels in Mechanical Ventilation in ARDS Patients
1 other identifier
interventional
14
1 country
1
Brief Summary
ARDS management is quite complex, and mortality is high. PEEP titration is very important in mechanical ventilation. However, the most appropriate approach for PEEP titration has yet to be determined. Currently, the emphasis is on focused PEEP implementation. The present study aimed to evaluate the volume gain at different PEEP levels over the pressure-volume curve, the changes in EELV measured by the modified multiple nitrogen wash-out/wash-in technique, and the compliance with respiratory mechanics. 14 adult ARDS patients undergoing invasive mechanical ventilation were included in the study. According to the Berlin Criteria, There were two mild, seven moderates, and five severe ARDS patients. FRC and EELV with decreased PEEP titration estimates (5 cmH2O) were measured by the multiple nitrogen wash-out/washin technique. Gain and compliance values were measured over the dynamic pressure-volume curves created by the intracheal pressure sensor.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 26, 2021
CompletedFirst Submitted
Initial submission to the registry
July 31, 2023
CompletedFirst Posted
Study publicly available on registry
August 15, 2023
CompletedAugust 15, 2023
August 1, 2023
24 days
July 31, 2023
August 8, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Does volume gain indicate recruited lung volume?
A dynamic compliance curve was generated during the analysis, and volume changes in this curve were determined at each PEEP level. The difference in EELV at two different PEEP levels during a descending PEEP trial was calculated as ∆EELV, and the difference between ∆EELV and the volume derived from the pressure-volume curve was calculated as "volume gain" (gain = ∆EELV - volume derived from the curve). The estimated lung volume recovered was calculated using the formula ∆EELV - (∆PEEP x Compliance PEEPlow) and compared with the volume gain.
Patients were ventilated for 10 minutes at each PEEP level.Measurement was taken after 10 minutes.]
Secondary Outcomes (4)
Static compliance correlation with volume gain.
Patients were ventilated for 10 minutes at each PEEP level.Measurement was taken after 10 minutes.
Calculation of respiratory system elastance and its correlation with volume gain.
Patients were ventilated for 10 minutes at each PEEP level.Measurement was taken after 10 minutes.
Examination of the relationship between static strain and volume gain.
Patients were ventilated for 10 minutes at each PEEP level.Measurement was taken after 10 minutes.
Investigation of the correlation between driving pressure and volume gain
Patients were ventilated for 10 minutes at each PEEP level.Measurement was taken after 10 minutes.
Other Outcomes (2)
Hemodynamic parameters of patient with ARDS were measured during different PEEP measurement.
Measurements were taken after 10 minutes of ventilating at the PEEP level.
Arterial blood gas analysis
Measurements were taken after 10 minutes of ventilating at the PEEP level.
Study Arms (1)
ARDS patient
OTHER14 patients with ARDS were included in the study. It was planned as a single group.
Interventions
Before the measurement, a recruitment maneuver was performed for 30-40 s at a PEEP level of 20 cmH2O. At four different PEEP levels of 15, 10, 5, and 0 cmH2O, a decreasing PEEP trial was performed, and the measurement results were recorded.The measurement time at each PEEP level was chosen as 10 minutes. At the end of the measurement, static compliance was measured by applying an end-inspiratory pause. Respiratory system elastance,static strain volume gain was calculated.The estimated lung volume recovered was calculated using the formula ∆EELV - (∆PEEP x Compliance PEEPlow) and compared with the volume gain.
Eligibility Criteria
You may qualify if:
- Patients diagnosed with ARDS according to the Berlin criteria
- Berlin definition criteria: (1) presence of acute hypoxemic respiratory failure, (2) onset within 7 days of insult, or or new (within 7 days) or worsening respiratory symptoms; (3) bilateral opacities on chest x-ray or CT not fully explained by effusions, lobar or lung collapse, or nodules; and (4) cardiac failure not primary cause of acute respiratory failure.
You may not qualify if:
- Patients with severe cardiovascular instability (Mean arterial pressure \<60 mmHg , Pulse \<45 or \>150), Patients with pneumothorax, Patients who have undergone pneumonectomy operation, Patients with Lung Transplantation, Patients with thoracic deformity, ARDS patients with cor pulmonale
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pamukkale University
Denizli, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Specialist, Department of Anesthesiology and Reanimation, MD
Study Record Dates
First Submitted
July 31, 2023
First Posted
August 15, 2023
Study Start
August 2, 2021
Primary Completion
August 26, 2021
Study Completion
August 26, 2021
Last Updated
August 15, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share