- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03435523
The Open Lung Approach During One Lung Ventilation in Thoracic Surgery
Optimal PEEP Based on the Open Lung Approach During One Lung Ventilation in Thoracic Surgery: a Physiological Study.
- Question: Ventilatory strategy to counterbalance the effect of one lung ventilation during thoracic surgery.
- Findings: the open lung approach improved oxygenation and lung compliance, reducing respiratory system driving pressure and transpulmonary driving pressure.
- Meaning: patients undergoing thoracic surgery during one lung ventilation may benefit of an open lung approach strategy to avoid ventilator lung injury.
Study Overview
Detailed Description
Background: During thoracic surgery in lateral decubitus, one lung ventilation (OLV) may impair respiratory mechanics and gas exchange. The investigators tested a strategy based on an open lung approach (OLA) consisting in lung recruitment immediately followed by a decremental positive-end expiratory pressure (PEEP) titration to the best respiratory system compliance (CRS) and separately quantified the elastic properties of the lung and the chest wall. The investigators hypothesis was that this approach would improve gas exchange and increase lung compliance (CL).
Methods: In thirteen patients undergoing upper left lobectomy the investigators studied lung and chest wall mechanics, transpulmonary pressure (PL), respiratory system and transpulmonary driving pressure (ΔPRS and ΔPL), gas exchange and hemodynamics at two time-points (a) during OLV at zero end-expiratory pressure (OLVpre-OLA) and (b) after the application of the open-lung strategy (OLVpost-OLA).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age > 18 years,
- surgery and OLV lasting ≥ 60 min
Exclusion Criteria:
- lung reduction surgery, pneumonectomy, patients with severe COPD with preoperative forced expiratory volume in 1 s (FEV1) to forced vital capacity (FVC) ratio, expressed as a percentage (FEV1/FVC%) <60%, presence of large bullae, pleural diseases and/or acute or chronic uncompensated cardiac disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Open lung approach
Recruitment maneuver during OLV in thoracic surgery
|
the ventilator was switched to pressure-control ventilation with a driving pressure of 20 cmH2O.
After a 3 min equilibration, PEEP was applied in steps of 5,10,15 and 20 cmH2O every five respiratory breaths; subsequently, after setting a driving pressure of 15 cmH2O, PEEP was stepwise reduced, starting from 15 cmH2O, by 2 cmH2O every 2 minutes.
The recruiting pressure of 20/20 was applied for six breaths.
During the decremental PEEP trial, CRS was measured at every step.
The PEEP level corresponding to highest CRS during the decremental trial was identified as the "best PEEP".
Subsequently, the lungs were recruited again and the "best" PEEP was applied.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in respiratory mechanics before and after the open lung approach
Time Frame: During surgery
|
Respiratory mechanics parameters were recorded, digitized and collected on a personal computer through a 12-bit analog-to digital converter board (DAQCard 700; National Instrument, Austin, TX) at a sample rate of 200 Hz (ICU Lab, KleisTEK Engineering, Bari, Italy).
|
During surgery
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Università di Foggia
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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