Effect of Perioperative Sigh Ventilation on Postoperative Hypoxemia and Pulmonary Complications After On-pump Cardiac Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Time-weighted average pulse oximetry (SpO2/FiO2)
研究概览
简要总结
Postoperative pulmonary complications (PPCs) remain a frequent event after pump-on cardiac surgery and are mostly characterized by postoperative hypoxemia.These complications are significant contributors to prolonged intensive care unit admissions and an escalation in in-hospital mortality rates.
The dual impact of general anesthesia with invasive mechanical ventilation results in ventilator-induced lung injury, while cardiac surgery introduces additional pulmonary insults. These include systemic inflammatory responses initiated by cardiopulmonary bypass and ischemic lung damage consequent to aortic cross-clamping. Contributing factors such as blood transfusions and postoperative pain further exacerbate the incidence of PPCs by increasing the permeability of the alveolar-capillary barrier and disrupting mucociliary functions, often culminating in pulmonary atelectasis.
Protective ventilation strategies, inspired by acute respiratory distress syndrome (ARDS) management protocols, involve the utilization of low tidal volumes (6-8mL/kg predicted body weight). However, the uniform application of low tidal volumes, especially when combined with the multifactorial pulmonary insults inherent to cardiac surgery, can precipitate surfactant dysfunction and induce atelectasis.
The role of pulmonary surfactant in maintaining alveolar stability is critical, necessitating continuous synthesis to sustain low surface tension and prevent alveolar collapse. The most potent stimulus for surfactant secretion is identified as the mechanical stretch of type II pneumocytes, typically induced by larger tidal volumes.
This background sets the foundation for a research study aimed at assessing the safety and efficacy of incorporating sighs into perioperative protective ventilation. This approach is hypothesized to mitigate postoperative hypoxemia and reduce the incidence of PPCs in patients undergoing scheduled on-pump cardiac surgery.
详细描述
The purpose of this single center, parallel group, randomized controlled study is to evaluate the effect of a perioperative sigh ventilation strategy on postoperative outcomes during the first 7 days following cardiac surgery. The study will include 192 adult patients undergoing scheduled on-pump cardiac surgery. The sigh ventilation approach will combine sigh ventilation and lung protective ventilation (6-8 ml/kg/pbw) from intubation to extubation. It will be compared to a conventional approach without sigh ventilation, with lung protective ventilation and positive end-expiratory pressure (PEEP) setting same as the intervention arm. The primary endpoint is the Spo2/Fio2 ratio during the initial post extubation hour. The secondary endpoints are postoperative pulmonary complications and hospital length of stay .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective cardiac surgery with general anesthesia
- •Conventional cardiopulmonary bypass and aortic cross clamp
- •Providing written informed consent by the patient himself/herself or the next of kin
排除标准
- •Emergent surgery including aortic dissection, cardiac rupture and active endocarditis surgery
- •Left ventricular assist device implantation
- •Patients anticipated to require intraoperative support with Extracorporeal Membrane Oxygenation (ECMO) or Intra-Aortic Balloon Pump (IABP)
- •Chronic pulmonary disease requiring long-term home oxygen therapy
- •Receiving invasive mechanical ventilation within 7 days prior to surgery
- •Preoperative shock
- •Obstructive Sleep Apnea Syndrome (OSAS) requiring intermittent non-invasive ventilatort support
- •Preoperative left ventricular ejection fraction<40%
- •Pulmonary arterial systolic pressure>50 mmHg
- •Redo surgery
研究组 & 干预措施
Conventional ventilation
- Lung protective ventilation from intubation to extubation, consisted of low tidal volume (6-8ml/kg/pbw) and positive end-expiratory pressure setting according to ARDS low PEEP-FiO2 table
Sigh ventilation
- Sigh breaths consisting of increasing positive end-expiratory pressure (PEEP) that produces a plateau pressure of 35 cmH2O (or 40 cmH2O in patients with BMIs > 35). The sigh breaths will be delivered once every 6 minutes, as part of usual invasive mechanical ventilation, from intubation to extubation.
- No sigh ventilation during thoracotomy
- Lung protective ventilation from intubation to extubation, consisted of low tidal volume (6-8ml/kg/pbw) and positive end-expiratory pressure setting according to ARDS low PEEP-FiO2 table
干预措施: Sigh ventilation (Procedure)
结局指标
主要结局
Time-weighted average pulse oximetry (SpO2/FiO2)
时间窗: 1 hour after endotracheal extubation
Calculated the SpO2/FiO2 ratio every 15min during the initial postextubation hour, then averaged the SpO2/FiO2 ratios weighted by measurement interval. The comparison between arms was made through T-test.
次要结局
- Proportion of respiratory failure(first 7 days postextubation)
- Severity of postoperative pulmonary complications(first 7 days after surgery)
- Invasive mechanical ventilation (IMV) days(first 7 days after surgery)
- Reintubation rate(first 7 days after surgery)
- Proportion of receiving non-invasive ventilation (NIV) or High-flow nasal cannula (HFNC) support(first 7 days after surgery)
- No ventilatory-support days(first 7 days after surgery)
- In-hospital mortality(From the day of surgery up to Hospital discharge or death, maximum censoring at day 28 after surgery)
- Length of ICU stay(From the day of surgery up to ICU discharge, maximum censoring at day 28 after surgery)
- Length of hospital stay(From the day of surgery up to Hospital discharge, maximum censoring at day 28 after surgery)
研究者
Fengmei Guo
Director of Intensive Care Unit, Principal Investigator, Clinical Professor, Zhongda Hospital, Southeast University, China
Zhongda Hospital