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临床试验/NCT06260826
NCT06260826已完成不适用

Comparison of Continuous Positive Airway Pressure Modes (Constant Via Facial Mask vs. Auto Via Nasal Mask) on Oxygenation and Pulmonary Function in Elderly Patients After Major Open Abdominal Surgery

Nguyen Dang Thu2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
The oxygenation-PaO2/FiO2

研究概览

简要总结

Postoperative continuous positive airway pressure (CPAP) can improve lung function. The risk of pulmonary complications is high after major abdominal surgery but may be reduced by prophylactic postoperative noninvasive ventilation using CPAP. This study compared the effects of auto-CPAP via a nasal mask (JPAP) and constant-CPAP via a facial mask (O2-Max Trio) on oxygenation and pulmonary function in elderly patients after major open abdominal surgery.

详细描述

After being informed about the study and potential risks, all patients giving written informed consent will undergo screening period to determine eligibility for study entry.

Patients aged over 60 years, scheduled for major open abdominal surgery (i.e., gastrectomy, colectomy, proctocolectomy, or abdominal aortic aneurysm repair).

All patients received standardized anesthetic management following the established protocols of our hospital. Before induction, an epidural catheter was placed in the epidural space at thoracic T7-9 level for upper abdominal surgery and at lumbaric L1-3 level for lower abdominal surgery. A 0.2% bupivacaine solution was administered with a 5 ml bolus dosage, maintained at 5 ml/h during surgery, and the infusion rate was adjusted for pain management until postoperative day 3. General anesthesia was induced using propofol, fentanyl, and rocuronium, with maintenance using sevoflurane. Neuromuscular blockade was monitored using the train-of-four (TOF) stimulation. Fentanyl and epidural infusion rates were adjusted to maintain the Surgical Pleth Index (SPI) in the range of 40-70. Extubation was only performed when the TOF ratio was > 90%.

In the PACU, after extubation, all patients lay on their backs with a backrest tilted to 45 degrees. Postoperative pain was assessed using a numeric rating scale (NRS; 0-10) and treated with epidural boluses or IV opioids if pain exceeded NRS 3 at rest or NRS 5 during movement. Acute pain, nausea, or circulatory problems were managed and ruled out. CPAP was administered when patients were conscious and had the ability to cough and expectorate phlegm.

Patients were randomly assigned in a 1:1 ratio to either the O2-Max Trio or JPAP group through a computer-generated randomization list.

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
None

盲法说明

the treatment allocation was unblinded to both the patient and the staffs

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient agrees to participate in the study
  • Age 60 or older
  • ASA I, II, III
  • Patients underwent open abdominal surgery under general anesthesia, and extubation without complications

排除标准

  • Upper airway deformities
  • Significant bullous emphysema
  • Bronchopleural fistula
  • Facial deformation
  • Non-epidural anesthesia
  • Hemodynamic unstable
  • Inability to provide consent.

结局指标

主要结局

The oxygenation-PaO2/FiO2

时间窗: Three time points: Before surgery, arrival at the post-anesthesia care unit (before CPAP), and 1 hour after CPAP

The partial pressure of oxygen in arterial blood (PaO2)/fraction of inspired oxygen (FIO2) ratio. PaO2 was measured by drawing 2 mL of blood from the radial artery and using a Cobas B221 blood gas analyzer (Roche, Basel, Switzerland), whereas the FIO2 was read from the CPAP apparatus.

次要结局

  • The forced vital capacity (FVC)(Three time points: Before surgery, arrival at the post-anesthesia care unit (before CPAP), and 1 hour after CPAP)
  • The peak expiratory flow-PEF(Three time points: Before surgery, arrival at the post-anesthesia care unit (before CPAP), and 1 hour after CPAP)
  • The forced expiratory volume in the first second-FEV1(Three time points: Before surgery, arrival at the post-anesthesia care unit (before CPAP), and 1 hour after CPAP)
  • The FEV1/FVC ratio(Three time points: Before surgery, arrival at the post-anesthesia care unit (before CPAP), and 1 hour after CPAP)

研究者

发起方
Nguyen Dang Thu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nguyen Dang Thu

Principal Investigator

Vietnam Military Medical University

研究点 (2)

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