Effect of Lung Protective One-lung Ventilation With Fix and Variable Positive End-expiratory Pressure (PEEP) on Oxygenation and Outcome: Randomized, Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypoxemia
- Sponsor
- University of Debrecen
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Intraoperative oxygenation
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
During One-lung ventilation, the use of lower tidal volumes (VT) is helpful to avoid over-distension, provide sufficient oxygenation, but can result in increased atelectasis.
Nevertheless, it is not known if, during one-lung ventilation with constant low VT, moderate levels of PEEP combined with lung recruitment maneuvers are superior to variable PEEP for intraoperative oxygenation and protection against PPCs.
Aim of the study is to compare a strategy using constant tidal volume with recruitment maneuvers versus variable PEEP with recruitment maneuvers during thoracic surgery in adults.
The investigators hypothesize that in adult, non-obese patients undergoing thoracic surgery under standardized OLV with variable PEEP and recruitment maneuvers as compared to constant PEEP without recruitment maneuvers prevent PPCs.
Patients will be randomly assigned to one of two groups:
FIX PEEP VOLUME GROUP (Groupfix): mechanical ventilation with constant (6 ml/kgIBW) tidal volume and PEEP of 5 cmH2O with recruitment maneuvers
VARIABLE PEEP GROUP (Groupvar): mechanical ventilation with constant (6 ml/kgIBW) tidal volume with variable PEEP with recruitment maneuvers.
Detailed Description
Lung separation will be performed by DLT technique. Mechanical ventilation will be applied in volume-controlled mode. During two-lung ventilation, VT will be set at 8 mL/kg predicted body weight. During one-lung ventilation, in GroupFix VT will be decreased to 6 mL/kg PBW with 5 cmH2O PEEP. In GroupVar VT mechanical ventilation with constant (6 ml/kgIBW) tidal volume with variable PEEP with recruitment maneuvers.
Investigators
Tamas Vegh, MD
Head, Division General, Vascular and Thoracic Anaesthesia
University of Debrecen
Eligibility Criteria
Inclusion Criteria
- •Patient scheduled for open thoracic or video-assisted thoracoscopic surgery under general anesthesia requiring OLV (no emergency surgery)
- •BMI \< 35 kg/m2
- •Age ≥ 18 years
- •Expected duration of surgery \> 60 min
- •Expected duration of anesthesia \> 90 min
Exclusion Criteria
- •COPD GOLD 3+4, lung fibrosis, documented bullae, severe emphysema, pneumothorax
- •uncontrolled asthma
- •NYHA 3+4, CCS 3+4
- •previous thoracic surgery
- •ARDS (Berlin definition)
- •documented pulmonary arterial hypertension \> 40 mmHg syst
- •documented or suspected neuromuscular disease (thymoma, myasthenia)
- •planned mechanical ventilation after surgery
- •bilateral procedures
- •lung separation with other method than DLT (eg diff. airway, trachestomy)
Outcomes
Primary Outcomes
Intraoperative oxygenation
Time Frame: 1 day
PaO2 \< 60 mmHg
Secondary Outcomes
- Postoperative pulmonary complications(90 days)
- 30 day survival/mortality(30 days)
- Postoperative oxygenation(90 days)
- 90 day survival/mortality(90 days)
- Postoperative extra-pulmonary complications(90 days)