跳至主要内容
临床试验/NCT05548309
NCT05548309已完成不适用

The Effect of High Flow Nasal Cannula Versus Simple Face Mask Oxygen Therapy on Pulmonary Complications After Major Abdominal Surgeries

Alexandria University1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2021年4月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
94
试验地点
1
主要终点
To compare the effect of HFNC and simple face mask oxygen therapy regarding postoperative pulmonary complications within five days after major elective upper abdominal surgeries.

研究概览

简要总结

Eighty adult patients were randomly categorized into two equal groups (forty patients each): HFNC was applied to group I, and a simple oxygen face mask was applied to group II. Postoperative pulmonary complications were assessed for five days later.

详细描述

After an informed written consent taken from all the patients included in this study, they were assessed thoroughly by:

  • Detailed medical and surgical history taking.
  • Complete clinical examination.
  • Routine laboratory investigations, including complete blood picture, blood urea nitrogen, serum creatinine, prothrombin (PT), activated partial thromboplastin (aPTT) times, thrombin time, fasting blood sugar.
  • Electrocardiograph (ECG) and chest x-ray.

On arrival of the patient to the operative theatre peripheral intravenous cannula gauge 18 was inserted and all patients were attached to multichannel monitor (CARESCAPE™ Monitor B650) to display the following:

  1. Heart rate (beats/ minute).
  2. Non-invasive systolic, diastolic, and mean arterial blood pressure (mmHg).
  3. Respiratory rate (breaths/min).
  4. Peripheral oxygen saturation (%).
  5. End tidal carbon dioxide (mmHg). Epidural catheter was inserted for all patients at level T7-T9, loading dose 1-1.5 ml/segment of 0.125% bupivacaine with fentanyl 1mic/ml and was continued as an infusion intraoperatively combined with general anaesthesia with infusion rate 5ml/hour. Mechanical ventilation was initiated after tracheal intubation using volume control mode.

At the end of the surgery lung recruitment was done by closing an adjustable pressure-limiting valve at continuous positive airway pressure 30 cmH2O2 for 30 seconds.Extubation was done after patients fulfilling the criteria of extubation.

研究设计

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

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (50-70 years).
  • Patients with American Society of Anesthesiologists (ASA) status I-III.
  • Patients with body mass index less than 35kg/m
  • Patients scheduled for major elective upper abdominal surgeries (gastrectomy, hepatic resection, pancreatectomy, Whipple procedures,..).
  • Upper abdominal surgery with an abdominal incision longer than 5 cm that is above or extending above the umbilicus.
  • Upper abdominal surgeries with an anticipated duration of two hours or more.
  • Exclusion Criteria :• Patients who refuse to participate in the study.
  • Patients with tracheostomy
  • .• Patients with pre-existing pulmonary disease (pleural effusion, pneumothorax or pulmonary atelectasis).
  • Patients with pre-existing obstructive sleep apnea.
  • Patients with any nasal or facial defect that could impede use of HFNC (Nasal septal defect or any form of facial deformity).
  • Impaired consciousness Glasgow coma scale (GCS) less than
  • Hemodynamic instability as systolic blood pressure less than 90 mmHg, mean arterial blood pressure less than 65 mmHg or vasopressor requirement.

排除标准

  • 未提供

结局指标

主要结局

To compare the effect of HFNC and simple face mask oxygen therapy regarding postoperative pulmonary complications within five days after major elective upper abdominal surgeries.

时间窗: 5 days postoperatively

postoperative pulmonery complications detected by lung ultrasound and chest x-ray

次要结局

  • Hospital length of stay(days)(21 days postoperatively)
  • To detect the need for escalation of respiratory support(5 days postoperatively)
  • Intensive care unit length of stay(days)(14 days postoperatively)

研究者

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

Huda abdellatif Boghdady

assistant lecturer,alexandria university

Alexandria University

研究点 (1)

Loading locations...

相似试验