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 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 12:35 AM
NCT ID:
NCT07126067
Brief Summary:
Protective ventilation strategies and alveolar recruitment maneuvers (ARM) are employed in patients with acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) to improve oxygenation, prevent alveolar collapse, and reduce ventilation-induced lung injury. Recruitment maneuvers aim to open and maintain alveoli. While positive effects on oxygenation have been observed in adults, limited data in children make the clinical efficacy of these strategies uncertain. Careful application and the development of individualized treatment protocols are recommended.
Detailed Description:
Experimental studies have proven a relationship between inappropriate ventilation measures and delayed or even worsened recovery from acute pulmonary injury. Therefore, the importance of protective ventilation combined with recruitment maneuvers emerges. In clinical practice, this relationship is believed to significantly reduce morbidity, mortality, and injuries caused by mechanical ventilation.
It is indicated in patients with severe hypoxemia, often due to acute lung injury caused by pneumonia or sepsis. The main contraindications are hemodynamic instability, pneumothorax, and intracranial hypertension. Experimental studies have shown that lung-protective ventilation has beneficial effects on both oxygenation and alveolar collapse. In children, lung-protective ventilation leads to significant reductions in alveolar collapse, lower oxygen requirements, improved pulmonary compliance, and decreased bronchopulmonary dysplasia. However, studies conducted on children are limited.
Recent changes have been made regarding how children with acute hypoxemic respiratory failure are ventilated. Lachmann proposed the "open lung concept," which involves opening the lungs and keeping them open during mechanical ventilation. ARM has been used for over two decades in mechanically ventilated patients with severe lung injury. Its most significant physiological outcome is the improvement in oxygenation in patients with lung damage. The procedure is typically followed by adjustments in PEEP levels, which play a fundamental role in maintaining the effectiveness of ARM. ARM is also used to prevent alveolar collapse during low tidal volume mechanical ventilation. However, its primary purpose is to protect the lungs from ventilator-induced injuries. PEEP has a key role in preventing atelectrauma and maintaining the maneuver's effectiveness. In clinical practice, these strategies are believed to significantly reduce morbidity and mortality.
In this study, it is aimed to define the limits of "diaphragm-protective ventilation" based on the clinical outcomes of our patients by evaluating the effects of different PEEP levels adjusted during laparoscopic abdominal surgery in pediatric patients. Additionally, it will be seeked to assess the impact of positive end-expiratory pressure levels on diaphragm thickness.
Our primary hypothesis is that, in patients where ideal PEEP is applied based on dynamic compliance measured with ultrasound (USG), diaphragm values will return closer to baseline values compared to those where recruitment maneuvers and ideal PEEP are applied.
Secondly, it is aimed to investigate the effects of calculating ideal PEEP using dynamic compliance measured with USG on hospital length of stay, intraoperative hemodynamic parameters, and respiratory parameters.
Study:
NCT07126067
Study Brief:
Protocol Section:
NCT07126067