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

NCT03968120 | Completed

• 1 other identifier: DE RKEB/IKEB 4918-2017
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxemia; Pulmonary Sepsis; ARDS, Human; Pneumonia

Outcome Measures

Primary Outcomes (1)

• Intraoperative oxygenation

  PaO2 \< 60 mmHg

  1 day

Secondary Outcomes (5)

• Postoperative pulmonary complications

  90 days

• Postoperative extra-pulmonary complications

  90 days

• 30 day survival/mortality

  30 days

• 90 day survival/mortality

  90 days

• Postoperative oxygenation

  90 days

Study Arms (2)

Group Fix:One-lung ventilation with constant PEEP

NO INTERVENTION

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

Group Variable:One-lung ventilation with variable PEEP

ACTIVE COMPARATOR

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

Other: Change of ventilatory settings

Interventions

Change of ventilatory settings OTHER

Change of Positive End-Exspiratory Pressure during one-lung ventilation

Group Variable:One-lung ventilation with variable PEEP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Debrecen: lead

Study Sites (1)

University of Debrecen, Department of Anaesthesiology and Intensive Care

Debrecen, 4032, Hungary

Location

MeSH Terms

Conditions

Hypoxia; Respiratory Distress Syndrome; Pneumonia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Tract Infections; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Division General, Vascular and Thoracic Anaesthesia

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 30, 2019
• Study Start: February 1, 2018
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: January 5, 2024

Record last verified: 2024-01

Locations

HU (1)