The Open Lung Approach During One Lung Ventilation in Thoracic Surgery
Primary Purpose
Hypoxemia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Recruitment maneuver
Sponsored by
About this trial
This is an interventional treatment trial for Hypoxemia
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Open lung approach
Arm Description
Recruitment maneuver during OLV in thoracic surgery
Outcomes
Primary Outcome Measures
Change in respiratory mechanics before and after the open lung approach
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT03435523
First Posted
February 8, 2018
Last Updated
February 14, 2018
Sponsor
University of Foggia
1. Study Identification
Unique Protocol Identification Number
NCT03435523
Brief Title
The Open Lung Approach During One Lung Ventilation in Thoracic Surgery
Official Title
Optimal PEEP Based on the Open Lung Approach During One Lung Ventilation in Thoracic Surgery: a Physiological Study.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2012 (Actual)
Primary Completion Date
November 30, 2012 (Actual)
Study Completion Date
November 30, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Foggia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open lung approach
Arm Type
Experimental
Arm Description
Recruitment maneuver during OLV in thoracic surgery
Intervention Type
Procedure
Intervention Name(s)
Recruitment maneuver
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in respiratory mechanics before and after the open lung approach
Description
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).
Time Frame
During surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
30382819
Citation
Rauseo M, Mirabella L, Grasso S, Cotoia A, Spadaro S, D'Antini D, Valentino F, Tullo L, Loizzi D, Sollitto F, Cinnella G. Peep titration based on the open lung approach during one lung ventilation in thoracic surgery: a physiological study. BMC Anesthesiol. 2018 Oct 31;18(1):156. doi: 10.1186/s12871-018-0624-3.
Results Reference
derived
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The Open Lung Approach During One Lung Ventilation in Thoracic Surgery
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