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Completed

NCT Number: NCT03364465

Lung Protective One-lung Ventilation With Fix and Variable Tidal Volume

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 low tidal volume 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 tidal volume with recruitment maneuvers during thoracic surgery in adults.

We hypothesize that in adult, non-obese patients undergoing thoracic surgery under standardized OLV with variable tidal volumes, modearte PEEP and recruitment maneuvers as compared to constant without recruitment maneuvers prevent PPCs.

Patients will be randomly assigned to one of two groups:

FIX TIDAL VOLUME GROUP (Groupfix): mechanical ventilation with constant (6 ml/kgIBW) tidal volume and PEEP of 5 cmH2O with recruitment maneuvers

VARIABLE TIDAL VOLUME GROUP (Groupvar): mechanical ventilation with variable (6 ml/kgIBW ± 33%) tidal volume with variable respiratory rate to maintain constant minute ventilation and PEEP of 5 cmH2O with recruitment maneuvers.

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Key information

Conditions

Hypoxemia ARDS, Human Hypoxia Infections Lung Diseases Pathological Conditions, Signs and Symptoms Pneumonia Pulmonary Sepsis Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Debrecen, Department of Anesthesiology and Intensive Care

Debrecen, 4032, Hungary

About this study

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 will be 6 ml/kg predicted body weight ±33% with 5 cmH2O PEEP. Respiratory rate will be adjusted to maintain same minute ventilation as during two-lung ventilation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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, tracheostomy)
  • 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)

Treatment and study plan

Change of ventilatory settings

Other

change of tidal volume during one-lung ventilation

Primary outcomes

  1. intraoperative oxygenation

    Time frame: 1 day

    PaO2 < 60 mmHg

Secondary outcomes

  1. postoperative pulmonary complications

    Time frame: 90 days

    infiltrate on chest X-ray, fever, laboratory and physical signs of infection

  2. postoperative extra-pulmonary complications

    Time frame: 90 days

    new atrial fibrillation

  3. 30-day survival/mortality

    Time frame: 30 days

    number of death within 30 days after surgery

  4. 90-day survival/mortality

    Time frame: 90 days

    number of death death within 90 days after surgery

Sponsors and collaborators

Lead sponsor

University of Debrecen

Other

Registry information

Official study title

Effect of Lung Protective One-lung Ventilation With Fix and Variable Tidal Volume on Oxygenation and Outcome: Randomized, Controlled Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 6, 2017
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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