The Hering-Breuer Reflex in Bilateral Lung Transplant Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- THBR/TSPONT ratio
研究概览
简要总结
The goal of this clinical trial (non-pharmacologic, single-center) is to determine whether the Hering-Breuer inflation reflex is preserved-and how it is modulated by end-expiratory pressure-in adult intensive-care patients who have undergone bilateral lung transplantation.
The study will enroll men and women ≥ 18 years admitted to the ICU during the early weaning phase and will include a comparison group of intubated ICU patients after major non-thoracic surgery.
The main questions it aims to answer are:
- Is the Hering-Breuer reflex (measured as the ratio THBR/TSPONT) absent or attenuated in double-lung-transplant recipients?
- Does changing the level of positive end-expiratory pressure (PEEP 8 vs 12 cmH₂O) influence the reflex?
Comparison group: Researchers will compare the transplant arm (post-bilateral lung transplantation) with the control arm (post-operative, non-thoracic surgery patients) to see whether loss or blunting of the reflex-and its response to PEEP-differs between the two cohorts.
Participants will:
- Have a nasogastric catheter with embedded electrodes positioned to record the electrical activity of the diaphragm (EAdi).
- Be ventilated in pressure-support mode at two preset PEEP levels (8 cmH₂O and 12 cmH₂O) during the weaning phase.
- Receive one standardized high-volume insufflation at ~30 cmH₂O in each PEEP condition to elicit the reflex, while EAdi, airway pressures, inspiratory/expiratory times, and tidal volumes are recorded for 10 minutes per level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years;
- •Both sexes;
- •For group 1: patients admitted to the Intensive Care Unit after undergoing bilateral lung transplantation, during respiratory weaning;
- •For group 2: patients admitted to the Intensive Care Unit for support or monitoring after non-thoracic surgery, who will arrive intubated.
排除标准
- •For group 1, patients meeting at least one of the following criteria will be excluded:
- •Re-transplantation or single-lung transplantation;
- •Urgent lung transplantation;
- •Post-transplant respiratory system compliance < 30 mL/cmH₂O;
- •Hemodynamic instability (defined as the presence of one or more of the following: plasma lactate > 4 mmol/L, need for vasoactive support with norepinephrine and/or epinephrine at a dose > 0.05 mcg/kg/min, systolic arterial pressure < 80 mmHg);
- •Increased risk of bleeding related to the placement of a nasogastric tube due to coagulopathy or severe thrombocytopenia (INR > 2 and platelets < 70,000);
- •Pregnancy
- •For group 2, patients presenting with one or more of the following criteria will be excluded:
- •Postoperative respiratory system compliance < 30 mL/cmH₂O;
- •Hemodynamic instability (defined as the presence of one or more of the following: plasma lactate > 4 mmol/L, need for vasoactive support with norepinephrine and/or epinephrine at a dose > 0.05 mcg/kg/min, systolic arterial pressure < 80 mmHg);
- •Contraindications to nasogastric tube placement (gastroesophageal surgery within the last 3 months, gastroesophageal bleeding in the previous 30 days, esophageal varices, facial trauma);
- •Increased risk of bleeding related to the placement of a nasogastric tube due to coagulopathy or severe thrombocytopenia (INR > 2 and platelets < 70,000);
- •History of lung transplantation or major thoracic surgery;
- •Pregnancy.
结局指标
主要结局
THBR/TSPONT ratio
时间窗: At the enrollment
Comparison of the ratio between the diaphragm electrical activation time after a high-volume breath aimed at eliciting the HBR (THBR) and a spontaneous breath (TSPONT), i.e., the THBR/TSPONT ratio, between patients who underwent bilateral lung transplantation and those who underwent non-thoracic surgery.
次要结局
- The variation of the THBR/TSPONT ratio as a function of PEEP(At the enrollment)
研究者
Giacomo Grasselli
Head of department of Anestesia and Intensive care unit
Policlinico Hospital