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

Not Applicable

Completed

• Conditions: Hypoxemia; Pulmonary Sepsis; ARDS, Human; Pneumonia
• Interventions: Other: Change of ventilatory settings

• Registration Number: NCT03968120
• Lead Sponsor: University of Debrecen

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.

Study Timeline

• Study Start: 2018-02-01
• Study First Submitted: 2019-05-14
• Study First Submitted QC: 2019-05-27
• Study First Posted: 2019-05-30
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-01
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Variable:One-lung ventilation with variable PEEP	Change of ventilatory settings	Variable group: lung protective one-lung ventilation with variable positive end-expiratory pressure (PEEP)

Primary Outcome Measures

Name	Time	Method
Intraoperative oxygenation	1 day	PaO2 \< 60 mmHg

Secondary Outcome Measures

Name	Time	Method
Postoperative pulmonary complications	90 days	Infiltrate or atelectasis on chest X-ray, fever, laboratory and physical signs of infection
30 day survival/mortality	30 days	number of death within 30 days after surgery
Postoperative oxygenation	90 days	SpO2/FiO2 ratio
90 day survival/mortality	90 days	number of death within 90 days after surgery
Postoperative extra-pulmonary complications	90 days	new atrial fibrillation, tachycardia, heart failure, myocardial infarct

Trial Locations

Locations (1)

University of Debrecen, Department of Anaesthesiology and Intensive Care; 🇭🇺 Debrecen, Hungary