Clinical trial NCT03182062: Individualized Perioperative Open-Lung Ventilatory Strategy During One-Lung Ventilation
Official title: Postoperative Complication and Hospital Stay Reduction With a Individualized Perioperative Lung Protective Ventilation During One-lung Ventilation: A Prospective, Multicenter, Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thoraric Surgery
Surgery Time Expected More Than Two Hours
Keywords: one lung ventilation
postoperative pulmonary complication
perioperative lung protective ventilation
Lead sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Sponsor class: OTHER
First posted: 2017-06-09
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether individualized ventilatory management during one-lung ventilation in patients scheduled for thoracic surgery, combining the use of low tidal volumes, alveolar recruitment maneuvers, individually titrated positive end-expiratory pressure and individually indicated ventilatory support will decrease postoperative pulmonary complications, ICU and hospital length of stay compared to a standardized Lung Protective Ventilation (LPV).


Eligibility criteria: Inclusion Criteria:

* Planned thoracic surgery \> 2 hours.
* Signed informed consent for participation in the study.

Exclusion Criteria:

* Age less than 18 years.
* Pregnant or breast-feeding.
* Patients with BMI \>35.
* Syndrome of moderate or severe respiratory distress: PaO2/FiO2 \< 200 mmHg.
* Heart failure: NYHA IV.
* Hemodynamic failure: CI \<2.5 L/min/m2 and / or requirements before surgery ionotropic support.
* Diagnosis or suspicion of intracranial hypertension (intracranial pressure\> 15 mmHg).
* Mechanical ventilation in the last 15 days.
* Presence of pneumothorax. Presence of giant bullae on chest radiography or computed tomography (CT).
* Patient with preoperatively CPAP.
* Participation in another experimental protocol at the time of intervention selection.

Primary outcomes:
measure: Reduction of postoperative pulmonary complications
timeFrame: Up to 7 postoperative days
Secondary outcomes:
measure: Reduction of composite of postoperative pulmonary complications
timeFrame: Up to 30 postoperative days
measure: Reduction of composite of postoperative complications
timeFrame: Up to 7 and 30 postoperative days
measure: Intensive care unit and hospital length of stay reduction
timeFrame: 1 year
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Valencia
country: Spain
facility: Hospital clínico universitario
Study officials:
affiliation: Department of Anesthesia and Critical Care; Hospital Clinico Universitario
name: Javier Belda, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Ferrando C, Mugarra A, Gutierrez A, Carbonell JA, Garcia M, Soro M, Tusman G, Belda FJ. Setting individualized positive end-expiratory pressure level with a positive end-expiratory pressure decrement trial after a recruitment maneuver improves oxygenation and lung mechanics during one-lung ventilation. Anesth Analg. 2014 Mar;118(3):657-65. doi: 10.1213/ANE.0000000000000105.
citation: Fleisher LA, Linde-Zwirble WT. Incidence, outcome, and attributable resource use associated with pulmonary and cardiac complications after major small and large bowel procedures. Perioper Med (Lond). 2014 Oct 7;3:7. doi: 10.1186/2047-0525-3-7. eCollection 2014.
citation: Licker MJ, Widikker I, Robert J, Frey JG, Spiliopoulos A, Ellenberger C, Schweizer A, Tschopp JM. Operative mortality and respiratory complications after lung resection for cancer: impact of chronic obstructive pulmonary disease and time trends. Ann Thorac Surg. 2006 May;81(5):1830-7. doi: 10.1016/j.athoracsur.2005.11.048.