Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-25 @ 4:27 AM
Ignite Modification Date: 2025-12-25 @ 4:27 AM
NCT ID: NCT02105220
Brief Summary: The goal of this study is to describe the influence of the chest wall on the respiratory system mechanics in morbidly obese patients and in patients with high intra-abdominal pressure. The effects of increasing and decreasing positive end-expiratory pressure (PEEP) on chest wall and total respiratory system mechanics, lung volumes and gas exchange will be evaluated, both during controlled and assisted mechanical ventilation. Patients will be studied, first, during the acute phase of respiratory failure, when requiring intubation and controlled mechanical ventilation. Then, patients will be evaluated again during weaning from the ventilator to assess the influence of PEEP in assisted ventilation prior to extubation.
Detailed Description: The goal of this study is to describe the influence of the chest wall on the respiratory system mechanics. Investigators want to describe how extreme obesity and Intra-Abdominal Hypertension (IAH) affect normal respiratory system behavior. The effects of increasing and decreasing positive end-expiratory pressure (PEEP) on respiratory system mechanics, lung volumes and gas exchange will be evaluated, both during controlled and assisted mechanical ventilation. Investigators will record and compare lung volumes, airway and transpulmonary pressure, gas exchange and hemodynamic changes caused by variations of PEEP. Patients will be studied, first, during the acute phase of respiratory failure, when requiring intubation and controlled mechanical ventilation. Patients will then again be evaluated during weaning from the ventilator to assess the influence of PEEP in assisted ventilation prior to extubation. Investigators believe that assessment of the transpulmonary pressure and lung volumes is essential to correctly evaluate respiratory system function in patients in which the relationship between the lung and chest wall is altered. Improper mechanical ventilation leads to lung damage. High ventilatory volume/pressure are associated with lung overdistension, while low volume/pressure leads to lung collapse and cyclic opening and closing of alveoli. All of these mechanisms have been associated with ventilator induced lung injury and poorer outcomes. Adequate PEEP and transpulmonary pressure are fundamental in preventing this vicious cycle.
Study: NCT02105220
Study Brief:
Protocol Section: NCT02105220