Pulmonary Complication, Thoracic Surgery
Conditions
Keywords
driving pressure, one-lung ventilation
Brief summary
This study aims to investigate the feasibility of a driving pressure limited mechanical ventilation strategy compared to a conventional strategy in patients undergoing one-lung ventilation during Video-assisted thoracoscopic lobectomy.
Detailed description
• More recently, the so-called lung-protective intraoperative ventilation strategies have been advocated to prevent lung injury. Such strategies aim at minimizing lung hyperinflation as well as cycling collapse and reopening of lung units, through the use of low tidal volumes (VTs) and positive end-expiratory pressure (PEEP). However, despite huge improvements in surgical and anesthesia techniques and management. It is surprising that, so far, mortality and pulmonary complication rates were not reduced over time .Recently, several investigations suggest an association between high driving pressure (the difference between the plateau pressure and the level of PEEP) and outcome for patients with acute respiratory distress syndrome. It is uncertain whether a similar association exists for high driving pressure during surgery and the occurrence of postoperative pulmonary complications. In this issue, Ary S Neto and colleagues report an individual patient data meta-analysis further investigating the risk of mechanical ventilation in healthy individuals during general anesthesia .After both a multivariate and mediation analysis, the driving pressure, but not the tidal volume or the positive end-expiratory pressure applied, seemed to be the only parameter that was associated with the development of postoperative pulmonary complications. This randomized controlled trial is aims to prove that driving pressure limited ventilation is superior in preventing postoperative pulmonary complications to existing protective ventilation.
Interventions
PROCEDUREProtective ventilation 1
Low tidal volume, high inspired oygen fraction (FiO2) and recruitment maneuver.
PROCEDUREProtective ventilation 2
Low tidal volume, PEEP, moderate inspired oygen fraction (FiO2) and recruitment maneuver.
PROCEDUREDriving Pressure Limited Ventilation
Positive end expiratory pressure is adjusted to minimize driving pressure, plateau pressure minus end expiratory pressure from 3 to 10 cmH2O during one-lung ventilation and a FiO2 of 60%
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults greater than or equal to 18 years 2. ARISCAT（Assess Respiratory Risk in Surgical Patients in Catalonia）≥26 points 3. Patients undergoing video-assisted thoracoscopic lobectomy
Exclusion criteria
1. The American Society of Anesthesiologists (ASA) Physical Status classification greater than or equal to 4 2. Emergency surgery 3. Pulmonary hypertension 4. Forced vital capacity or forced expiratory volume in 1 sec \< 70% of the predicted values 5. Coagulation disorder 6. Pulmonary or extrapulmonary infections 7. History of treatment with steroid in 3 months before surgery 8. History of recurrent pneumothorax 9. History of lung resection surgery 10. History of mechanical ventilation in 2 weeks 11. Body Mass Index\[≥35 kg／m2 \] 12. Patient who is contraindicated with application of positive end expiratory pressure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of postoperative pulmonary complications | within the first 3 days after surgery | Patient is regarded to have postoperative pulmonary complication when 4 or more positive variables exists according to Melbourne Group Scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| respiratory compliance | during surgery | Dynamic compliance, Static compliance |
| TNF-α | the start of one-lung ventilation, 1 hour of one-lung ventilation and the end of one-lung ventilation | — |
| IL-8 | the start of one-lung ventilation, 1 hour of one-lung ventilation and the end of one-lung ventilation | — |
| Partial pressure of oxygen in arterial blood | 15 min after induction, 20 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation, 1 hour after the end of surgery | — |
| In-hospital mortality | Patients will be followed during the period of hospital stay, an expected average of 28 days | — |
| 28-day survival | From day 0 to day 28 | — |
| ICU mortality | Patients will be followed during the period of hospital stay, an expected average of 28 days | — |
Countries
China
Contacts
Primary ContactLiu gongjian, M.D/Ph.D
Outcome results
None listed