Andre P Schmidt
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
NCT Number: NCT03616210
Background and goal of the study: Postoperative complications following major surgeries are associated with a significant increase in costs and mortality. There is increasing evidence that mechanical ventilation with a protective strategy using low tidal volume prevents postoperative pulmonary complications. Peripheral vascular surgeries include particularly surgeries for arterial revascularization of the lower limbs in patients with advanced peripheral vascular disease. These procedures are strongly associated with major cardiovascular morbidity postoperatively. In this specific group of patients, the presence of postoperative pulmonary complications (PPC) may be associated with worsening of clinical outcomes with a consequent significant increase in perioperative morbidity.
Subjects and methods: In this study, the investigators aimed to compare the effects of controlled mechanical ventilation with the use of a protective strategy (low tidal volume associated with elevated PEEP) when compared to the conventional strategy (higher tidal volume associated with reduced PEEP levels) on the rate of PPC in patients undergoing peripheral vascular surgery. This study was delineated as a prospective trial, compared to the control group (conventional ventilation strategy). Patients and researchers were blinded during data collection. The investigators included adult patients, ASA status II to IV, aged over 18 years, scheduled to undergo lower limb arterial bypass surgery. Patients were randomized to treatment with conventional mechanical ventilation (tidal volume between 9 to 10 ml.kg-1 of predicted body weight and PEEP between 3 and 5 cmH2O - Group I or control) or treatment with protective ventilation strategy (tidal volume of 6 to 7 ml.kg-1 of predicted body weight and PEEP of 6 to 8 cmH2O - Group II or treatment). The primary outcome was PPC and the secondary endpoint included hemodynamic and metabolic changes perioperatively. Statistical analysis was performed using the intention-to-treat method.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Protective ventilation strategy with tidal volume of 6 to 7 ml.kg-1 of predicted body weight and PEEP of 6 to 8 cmH2O.
Time frame: 7 days
The main outcome was the presence of any pulmonary complication (composite endpoint) after surgery and until discharge. These pulmonary complications included severe hypoxemia, suspected pulmonary infection, documented atelectasis or pulmonary infiltrate, bronchospasm, pulmonary edema, pleural effusion, pneumothorax, or development of ARDS. The presence of at least one of the findings described above was considered as a positive primary outcome.
Time frame: 7 days
Hypotension and need for continuous vasopressors (i.e., systolic arterial blood pressure < 90 mmHg for more than 5 min).
Hospital de Clinicas de Porto Alegre
Other
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.
Published trials that share one or more normalized conditions with this study.
NCT07552779
COVID-19, COVID-19 (Coronavirus Disease 2019)
Brussels, Bruxelles-capitale, Région de, Belgium
View Trial DetailsNCT04776447
Bronchial Neoplasms, Carcinoma Bronchiogenic Stage III
Alicante, Spain
View Trial DetailsNCT06728709
Gynecologic Cancer, Lung Diseases
Cairo, Cairo Governorate, Egypt
View Trial DetailsNCT03250897
Lung Diseases, Respiratory Tract Diseases
Rennes, France
View Trial Details