Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03364465
Enrollment
140
Registered
2017-12-06
Start date
2017-02-01
Completion date
2018-04-01
Last updated
2019-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS, Human, Hypoxemia, Pneumonia, Pulmonary Sepsis

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 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.

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 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.

Interventions

change of tidal volume during one-lung ventilation

Sponsors

University of Debrecen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
intraoperative oxygenation1 dayPaO2 \< 60 mmHg

Secondary

MeasureTime frameDescription
postoperative pulmonary complications90 daysinfiltrate on chest X-ray, fever, laboratory and physical signs of infection
postoperative extra-pulmonary complications90 daysnew atrial fibrillation
30-day survival/mortality30 daysnumber of death within 30 days after surgery
90-day survival/mortality90 daysnumber of death death within 90 days after surgery

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026