Effect of Lung Protective One-lung Ventilation With Fix and Variable PEEP on Oxygenation and Outcome

University of Debrecen

Status: Completed

Conditions: Pulmonary Sepsis; ARDS, Human; Pneumonia; Hypoxemia

Treatments: Other: Change of ventilatory settings

Study type: Interventional

Funder types: Other

Identifiers

NCT03968120

DE RKEB/IKEB 4918-2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)
• surgery in prone position
• persistent hemodynamic instability, intractable shock
• intracranial injury or tumor
• enrollment in other interventional study or refusal of informed consent
• pregnancy (excluded by anamnesis and/or laboratory analysis)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

Group Fix:One-lung ventilation with constant PEEP

No Intervention group

Description:

Controll group: lung protective one-lung ventilation with fix positive end-expiratory pressure (PEEP)

Group Variable:One-lung ventilation with variable PEEP

Active Comparator group

Description:

Variable group: lung protective one-lung ventilation with variable positive end-expiratory pressure (PEEP)

Treatment:

Other: Change of ventilatory settings