Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Prospective Single Blind Controlled Study to Assess the Efficacy of a Lung Protective Ventilation Strategy in the Prevention of Reperfusion Lung Injury Following PTE
Brief Summary: Chronic thromboembolic pulmonary hypertension (CTEPH) is caused by unresolved thromboemboli in the pulmonary arteries, which lead to pulmonary hypertension and, left untreated, right heart failure. This disease can be potentially cured by performing a pulmonary thromboendarterectomy (PTE) to remove the blood clots. The surgery is not without risk and the most worrisome complication is the development of a form of acute lung injury called reperfusion lung injury, which occurs in about 40 percent of patients.

The landmark publication of the ARDSNET study demonstrated that a low tidal volume strategy of mechanical ventilation, decreased morbidity and mortality in patients who had acute respiratory distress syndrome (ARDS). Since then there have been some studies examining the role of a low tidal volume strategy in all patients who are mechanically ventilated. Some studies have demonstrated a decreased incidence of acute lung injury while others have failed to do the same. In patients at high risk for developing acute lung injury, such as patients undergoing PTE, there may be a benefit to using low tidal volumes to reduce the incidence of reperfusion lung injury.

To assess the efficacy of a low tidal volume ventilation strategy in patients undergoing PTE, 134 patients will be randomized at the time of surgery to either low tidal volumes (6ml/kg of ideal body weight), or standard tidal volumes (10ml/kg of ideal body weight). Patients will be followed clinically to assess for the development of reperfusion lung injury. This will be defined as the development of hypoxemia (PaO2/FiO2 ratio less than 300) and chest infiltrates in the area of reperfused lung with no other identifiable etiology within the first 72 hours of surgery. Patients will also be assessed for other factors known to contribute to acute lung injury including: plateau pressures, peak inspiratory pressures, fluid balance, and number of transfusions received. Secondary endpoints of the study will be: time to successful spontaneous breathing trial, ventilator free days, ICU free days, hospital free days, and mortality.


Options:
A: Intervention Type: OTHER; Name: Mild intraoperative hypercapnia (50 mmHg vs. 30 mmHg); Assigned to Arm(s): N/A | Intervention Type: OTHER; Name: Supplemental oxygen (80% vs. 30%); Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Dexamethasone; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): N/A
B: Arm Label: Low tidal volume; Type: EXPERIMENTAL; Interventions: Other: Ventilation Strategy | Arm Label: Usual care; Type: ACTIVE_COMPARATOR; Interventions: Other: Ventilation Strategy | Intervention Type: OTHER; Name: Ventilation Strategy; Assigned to Arm(s): Low tidal volume, Usual care
C: Arm Label: Individualized ventilation; Type: EXPERIMENTAL; Interventions: Procedure: Alveolar recruitment maneuver, Procedure: Calculation of optimal PEEP | Arm Label: Individualized vent. + postop. CPAP; Type: EXPERIMENTAL; Interventions: Procedure: Alveolar recruitment maneuver, Procedure: Calculation of optimal PEEP, Procedure: Postoperative CPAP | Arm Label: Standard ventilation; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Standard vent. + postoperative CPAP; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Postoperative CPAP | Intervention Type: PROCEDURE; Name: Alveolar recruitment maneuver; Assigned to Arm(s): Individualized vent. + postop. CPAP, Individualized ventilation | Intervention Type: PROCEDURE; Name: Calculation of optimal PEEP; Assigned to Arm(s): Individualized vent. + postop. CPAP, Individualized ventilation | Intervention Type: PROCEDURE; Name: Postoperative CPAP; Assigned to Arm(s): Individualized vent. + postop. CPAP, Standard vent. + postoperative CPAP
D: Arm Label: high VT group; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Low tidal volume; Type: EXPERIMENTAL; Interventions: Procedure: Low tidal volume, Other: low tidal volume | Intervention Type: PROCEDURE; Name: Low tidal volume; Assigned to Arm(s): Low tidal volume | Intervention Type: PROCEDURE; Name: Low tidal volume; Assigned to Arm(s): Low tidal volume | Intervention Type: OTHER; Name: low tidal volume; Assigned to Arm(s): Low tidal volume

Answer: B