CompletedNot Applicable

Very Low Tidal Volume vs Conventional Ventilatory Strategy for One-lung Ventilation in Thoracic Anesthesia

Italy984 participantsStarted 2013-09

Plain-language summary

The purpose of this study is to determine if a protective ventilatory strategy during one-lung ventilation (OLV) based on low tidal volume, PEEP and alveolar recruitment maneuver can reduce Acute Respiratory Distress Syndrome (ARDS) and Postoperative pulmonary complications (PPCs) after major pulmonary resection. Primary endpoint: Evaluation of postoperative ARDS incidence Secondary endpoint: Evaluation od PPC incidence and postoperative outcomes (other complications, unplanned Intensive Care Admission, hospital and ICU length of stay, in-hospital mortality)

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients ≥ 18 years * ASA IV * Elective thoracotomies or thoracoscopic major lung resection surgery (lobectomy, bilobectomy, pneumonectomy) Exclusion Criteria: * Emergency surgery * Wedge resection or atypical resection * Non-resective lung surgery requiring OLV * Patients \< 18 years * BMI \< 20 and BMI \> 29 * Heart disease with ejection fraction \<50% and/or severe valvulopathy * Pulmonary hypertension * Renal failure requiring dialytic treatment * Drug addiction * Mental retardation, depression and psychiatric disease * Motor or sensory deficit * Pregnancy

What they're measuring

Acute Respiratory Distress Syndrome (ARDS) incidence

Timeframe: Hospital stay (7 days average expected)

Trial details

NCT IDNCT01504893

SponsorAzienda Ospedaliera S. Maria della Misericordia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-08

View on ClinicalTrials.gov More Acute Respiratory Distress Syndrome trials