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临床试验/NCT01762709
NCT01762709已完成1 期

Effects of Different Tidal Volumes on Extravascular Lung Water Content During One-lung Ventilation for Video-assisted Thoracoscopic Surgery: Dammam University Experience

Imam Abdulrahman Bin Faisal University2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
39
试验地点
2
主要终点
Extra vascular lung water (EVLW)

研究概览

简要总结

The use of low tidal volume (TV) during one lung ventilation (OLV) for thoracic surgery decreases the incidence of postoperative acute lung injury (ALI). We postulated that the use of low TV during OLV for video-assisted thoracoscopic surgery (VATS) would decrease the extravascular lung water content index (EVLWI). After local ethics committee approval and informed consent, we will randomly allocate 60 patients scheduled for elective VATS to ventilate the dependent lung with VT of 4, 6, or 8 mL/kg (n= 20 for each), I: E ratio 1: 2.5, PEEP of 5 cm H2O, recruitment maneuvers and respiratory rate will be adjusted to maintain normocapnia. Perioperative changes in EVLWI, hemodynamics, oxygenation index will be recorded. Also, the incidence of postoperative ALI, morbidity, hospitalization and mortality will be recorded

详细描述

Nowadays most thoracic procedures are performed via video-assisted thoracoscopic surgery (VATS) which necessitates the use of one lung ventilation (OLV).

Acute lung injury (ALI) is the most serious pulmonary complication after lung resection which may be aggravated with the use of large tidal volume (TV) and high peak airway pressures (Paw) during one-lung ventilation (OLV). In a large multicenter trial included 861 patients at 10 university centers of the Acute Respiratory Distress Syndrome Network of the National Heart, Lung, and Blood Institute, the use of lower tidal volumes from 4 to 6 ml/kg of the predicted body weight (PBW) during ventilation in patients with acute lung injury and the acute respiratory distress syndrome may reduce injurious lung stretch, the release of inflammatory mediators, days of mechanical ventilation and mortality (P=0.007).

By the late 1990s the standard VT for managing thoracic surgical patients had already been adjusted downwards [from 10 to 12 ml/kg in the 1980s] to 8 to 10 ml/kg, although no specific guidelines existed for one-lung ventilation.

The implementation of lung protective strategy during OLV using low TV [5-6 ml/kg PBW], pressure-controlled ventilation, limiting inspiratory plateau pressures and adding end-expiratory positive pressure (PEEP) with or without recruitment maneuvers has been shown to attenuate the incidence of ALI by 76-82% and satisfactory gas exchange after lung surgery without inducing a possible inflammatory/remodeling response.

The use of lower tidal volumes for OLV with subsequently decreased peak airway pressures may be associated with less production of tumor necrosis factor (TNF)-alpha and soluble intercellular adhesion molecule (sICAM)-1.8 Recent data have highlighted the role of extra vascular lung water index (EVLWI) as a useful good parameter for early diagnosis of pulmonary complication including acute lung injury after thoracic surgery. The diagnosis of postoperative ALI is often delayed because clinical signs of pulmonary edema present only once the extra vascular lung water (EVLW) exceeds 7 ml/kg (ideal body weight).

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 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • American Society of Anesthesiologists physical classes from II to III

排除标准

  • decompensated cardiac diseases
  • pulmonary diseases
  • hepatic diseases
  • renal diseases
  • pulmonary hypertension
  • obesity with a body mass index >35 kg/m2
  • preoperative mechanically ventilated
  • urgent procedures
  • previous history of pneumonectomy, bilobectomy, or lobectomy

结局指标

主要结局

Extra vascular lung water (EVLW)

时间窗: Change from baseline up to 3 hours after surgery.

extra vascular lung water (EVLW)

次要结局

  • Arterial tension to inspired fraction of oxygen (PaO2/FiO2) ratio(Change from baseline up to 3 hours after surgery.)
  • Arterial carbon dioxide tension (PaCO2)(Change from baseline up to 3 hours after surgery.)
  • Postoperative complications(Change from baseline up to 3 hours after surgery.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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