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临床试验/NCT04262037
NCT04262037Unknown不适用

A Comparative Study of Three Modes of Ventilation During Cardiopulmonary Bypass in Pediatric Patients With Pulmonary Hypertension Undergoing Congenital Heart Disease Surgeries

Cairo University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
24
试验地点
2
主要终点
• Direct pulmonary artery systolic pressure (PASP) measured in mmHg

研究概览

简要总结

Aim of Work:

The aim of this randomized, double-blinded, study is to compare between three modes of ventilation during cardiopulmonary bypass in pediatric patients with pulmonary hypertension undergoing corrective cardiac surgeries.

Hypothesis:

The hypothesis of the present study is that high frequency low volume positive pressure ventilation is better than continous positive airway pressure (CPAP)and passive deflation on direct PAP (pulmonary artery pressure ) reading and immediate oxygenation after cardiopulmonary bypass CPB in pediatric patients undergoing cardiac surgeries for congenital heart defects.

详细描述

The patients will be randomized in a double blinded fashion to get enrolled into 3 equal groups: Group HFPPV patients (n = 8) will receive high frequency positive pressure ventilation during cardiopulmonary bypass at tidal volume 2 ml/kg and respiratory rate 80, whereas Group CPPV patients (n = 8 ) will receive continuous positive airway pressure of 10 cmH2O during the bypass, while Control group patients (n = 8 ) will be disconnected from the ventilation (passive deflation) .The study will be conducted in the pediatric cardio-thoracic operation rooms in AbulReesh Hospital in Cairo University.

Advanced Monitoring where Naso-pharyngeal temperature probe will be placed, a Central venous catheter to monitor central venous pressure and an arterial cannula to monitor invasive blood pressure after that, standard cardiopulmonary bypass technique will be used in all patients. Before aortic cannulation, patients will receive IV heparin 400 U.kg-1 aiming to produce activated clotting time ACT value > 400 sec. A membrane oxygenator (minimax plus; Medtronics Inc.) will be used during cardiopulmonary bypass. Priming solution in the form of iso-tonic saline solution supplemented with heparin added to fresh whole blood in appropriate amounts to achieve a haematocrit 20-25% during CPB will be used. Furosemide in a dose of 1 mg/kg/min will be given to all patients. Venting of left heart will be performed with a left atrial vent inserted through a small incision at the inter-atrial septum. Anesthesia during CPB will be given by Sevoflurane administrated via a vaporizer inserted into the oxygenator gas supply with a constant gas flow 3 liter/min. A non-pulsatile roller pump (model10.10.00; Stocket instruments; Munich, Germany) will be used and the pump flow will be adjusted at 2.4 to 2.6 L/min /m2 during the normothermic period targeting mean arterial blood pressure between 40 and 60 mmHg. Moreover, all patients will receive milrinone loading dose of 50mcg/kg/min the maintanence 0.5-1 mcg/kg/min and or adrenaline 0.02-0.1 mcg/kg/min will be utilized to facilitate weaning from CPB.

After sternotomy and direct exposure of the pulmonary artery, the pulmonary artery systolic pressure (PASP) will be monitored by a direct arterial catheter 22 gauge inserted by the surgeon into the pulmonary artery, was calculated and recorded immediately after sternotomy, after aortic clamp removal, and 10 minutes after initiation of protamine infusion).

After application of aortic cross clamp and administration of cold blood cardioplegia solution (Saint Thomas cardioplegic solution) 40 ml/Kg to be followed by doses of 10ml/Kg every 30 minutes.), Group A patients will receive high frequency low volume positive pressure ventilation (HFPPV) during cardiopulmonary bypass at tidal volume Vt 2 ml/kg and respiratory rate RR 80, whereas Group B patients (n =8 ) will receive continous positive airway pressure CPAP of 10 cmH2O, and group C patients will be disconnected from the ventilator (passive deflation) .

Finally, Lung Ultrasound Score will be obtained after induction of anesthesia and at the end of surgery after chest closure, The duration of mechanical ventilation, length of stay in the intensive care unit and immediate post bypass oxygenation as well as the requirement for inotropic and vaso-tropic support during the first 24 hours study period will be recorded for all patients

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
4 Months 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age: 4 months to 6 years.
  • ASA I, II, III.
  • Patients undergoing atrial septal defect or ventricular septal defect or common atrio-ventricular canal corrective cardiac surgeries on cardiopulmonary bypass
  • Patients suffering moderate to severe pulmonary hypertension.

排除标准

  • Any congenital anomalies of the lung as cystic fibrosis, congenial diaphragmatic hernia.
  • Mild pulmonary hypertension or normal PAP.
  • Patients who will require high doses of inotropes (adrenaline > 0.1 mcg/kg/min or milrinone > 1 mcg/kg/min) will be excluded from the study.

结局指标

主要结局

• Direct pulmonary artery systolic pressure (PASP) measured in mmHg

时间窗: immediately after sternotomy,

the pulmonary artery systolic pressure (PASP) will be monitored by a direct arterial catheter 22 gauge inserted by the surgeon into the pulmonary artery, immediately after sternotomy, after aortic clamp removal, and 10 minutes after initiation of protamine infusion

Change in direct pulmonary artery systolic pressure (PASP) measured in mmHg

时间窗: 10 minutes after initiation of protamine

he pulmonary artery systolic pressure (PASP) will be monitored by a direct arterial catheter 22 gauge inserted by the surgeon into the pulmonary artery, immediately after sternotomy, after aortic clamp removal, and 10 minutes after initiation of protamine infusion

次要结局

  • • Lung ultrasound score.(beginning of surgery)
  • Change in Lung ultrasound score(End of suregery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mai Madkour

Lecturer of Anesthesia

Cairo University

研究点 (2)

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