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临床试验/NCT04048798
NCT04048798Unknown不适用

Effect of Nasal High Flow on Perioperative Oxygenation in Patients Undergoing Bariatric Surgery

Istanbul University0 个研究点目标入组 112 人开始时间: 2020年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
112
主要终点
PO2 value

研究概览

简要总结

High frequency nasal cannula (HFNC) provides an inspiration O2 fraction of 21-1% and it has a minimal dead space and can be well tolerated due to humidified air. Group I patients will be applied HFNC before and after bariatric surgery, Group II patients will be applied a constant O2 concentration via face mask. Oxygen pressure, oxygen saturation, carbon dioxide, respiration frequency, forced vital capacity will be measured before and after surgery.

详细描述

Morbid obese patients are prone to atelectasis and hypoxemia after bariatric surgery. High frequency nasal cannula (HFNC) provides an inspiration O2 fraction of 21-1% and it has a minimal dead space and can be well tolerated due to humidified air. It provides 5-7 cm H2O positive end expiratory pressure to the airways and may prevent atelectasis. In the preoperative room, forced vital capacity, peripheral oxygen saturation (SpO2), respiratory frequency, heart rate (HR), blood pressure (BP), carbon dioxide, oxygen pressure and carbon dioxide partial pressure values in blood gas analysis will be recorded. We will apply HFNC in the preoperative and postoperative period to Group I patients, while applying a constant O2 concentration to Group II patients. After appliying HFNC for two hours in Group I patients and O2 via face mask in Group II patients measurements will be repeated. During surgery, similar mechanical ventilation parameters will be applied to the patients. After the operation Group I patients will be applied HFNC, while Group II patients will be applied O2 via face mask in the recovery room for two hours. Measurements will be repeated. Primary end point of the study is the association between oxygen pressure, carbon dioxide partial pressure values among preoperative before and after HFNC and O2 and postoperative times.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients with a body mass index of 40-55 kg/m2
  • •American Society of Anesthesiologists score II-III
  • •Patients undergoing laparoscopic sleeve gastrectomy or one anastomosis gastric bypass

排除标准

  • •Obstructive sleep apnea syndrome
  • •Using a non invasive mechanical ventilation device preoperatively
  • •Patients whoo will predicted to postanesthesia care unit admission postoperatively

研究组 & 干预措施

Oxygen therapy via HFNC

Active Comparator

Patients who will be applied high frequency nasal cannula before and after surgery

干预措施: Oxygen therapy via HFNC (Other)

Oxygen therapy via face mask

Active Comparator

Patients who will be applied O2 via face mask before and after surgery

干预措施: Oxygen therapy via face mask (Other)

结局指标

主要结局

PO2 value

时间窗: 24 hours

PO2 value will be measured before HFNC or face mask, after HFNC or face mask and after surgery

PCO2 value

时间窗: 24 hours

PO2 value will be measured before HFNC or face mask, after HFNC or face mask and after surgery

次要结局

未报告次要终点

研究者

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

Dr Cigdem Akyol Beyoğlu

Principal Investigator

Istanbul University

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