Individualized Perioperative Open Lung Ventilatory Strategy
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2014 |
| End Date: | December 2016 |
| Contact: | Carlos Ferrando, MD, PhD |
| Email: | info@anestesiaclinicovalencia.org |
| Phone: | 0034963862600 |
Postoperative Complication and Hospital Stay Reduction With a Individualized Perioperative Lung Protective Ventilation. A Comparative, Prospective, Multicenter, Randomized Controlled Trial.
The purpose of this study is to determine whether individualized ventilatory management
combining the use of low tidal volumes, alveolar recruitment maneuvers, individually
titrated positive end-expiratory pressure and postoperative individualized ventilatory
support will decrease postoperative complications, unplanned ICU readmissions, ICU and
hospital length of stay and mortality compared to a standardized Lung Protective Ventilation
(LPV) for all patients at risk.
combining the use of low tidal volumes, alveolar recruitment maneuvers, individually
titrated positive end-expiratory pressure and postoperative individualized ventilatory
support will decrease postoperative complications, unplanned ICU readmissions, ICU and
hospital length of stay and mortality compared to a standardized Lung Protective Ventilation
(LPV) for all patients at risk.
Inclusion Criteria:
- Age not less than 18
- Risk of postoperative pulmonary complication moderate-high defined by a score ≥ 26 on
the risk scale ARISCAT (based on the analysis of seven factors, where a score between
26 and 44 points defines a moderate risk, and a score> 44 points define a high risk,
included in the Information Booklet Investigator).
- Planned abdominal 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.
We found this trial at
2
sites
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Robert M Kacmared, MD, PhD
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Mar de Plata, Buenos Aires
Principal Investigator: Gerardo Tusman, MD, PhD
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