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临床试验/NCT03828513
NCT03828513进行中(未招募)不适用

Can the Effects of High Flow Nasal Cannula Oxygenation on Postoperative Atelectasis be Evaluated With Lung Ultrasound: A Randomized Controlled Prospective Study

Kocaeli Derince Education and Research Hospital2 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
100
试验地点
2
主要终点
Evaluation of postoperative atelectasis in bariatric surgery patients

研究概览

简要总结

Evaluate the effects of high-flow nasal oxygen therapy on atelectasis in the perioperative period by lung ultrasound (LUS) in bariatric surgery patients.

详细描述

In obese patients, lung compliance decreases by 25% and Functional Residual Capacity decreases by about one-third. As they consume about 25% more oxygen than non-obese individuals, postoperative pulmonary complications occur more commonly. POINT (Peri-Operative Insufflatory Nasal Therapy) provides humidified and heated high flow oxygen therapy in perioperative period. High-flow nasal oxygen (HFNO) facilitates oxygenation and ventilation of both the spontaneously breathing and apnoeic patient.High-flow nasal cannula oxygen came to prominence in anaesthesia when it was shown to prolong the time to oxygen desaturation in patients with a difficult airway.

Lung ultrasonography (LUS) has been used more frequently in the diagnosis of pulmonary pathologies than chest radiography. This prospective observational study is to evaluate the effects of high-flow nasal oxygen therapy on atelectasis in the perioperative period by lung ultrasound (LUS) in bariatric surgery patients.

Materials and Methods

Following the Ethics Committee approval and written informe consents, 100 adult bariatric surgery patients are include in this observational study. The patients are randomly distributed into two groups ; High Flow Nasal Cannula Oxygenation(HFNCO) made group(n:50); HFNCO not made group(n:50).

HFNCO is start at a flow rate of 20 L/min with 100% oxygen in the preoperative period. It is titrate up to 50 L/min and increase to 80 L/min under general anesthesia until tracheal intubation. Atelectasis evaluation with lung ultrasound is performe and score in 6 different areas before and after HFNCO.

Pulmonary function tests and blood gas parameters are compared.During the procedure, the patient's blood pressure, heart rate, oxygen saturation, any complications that may develop will be recorded.nduction of anesthesia; difficult airway management, difficult mask and / or difficult intubation incidence, Mallampati scores, the use of one of the difficult intubation techniques during intubation (such as FastTrack, videolaryngoscopy or fiberoptic intubation), perioperative mechanical ventilation parameters (ventilation mode, tidal volume, respiratory frequency, end of tidal CO2 (carbon dioxide) pressure, PEEP usage, SpO2 (saturation oxygen), airway peak pressure, urine volume, arterial blood gas parameters are recorded.Duration of operation, surgical method (laparotomy / laparoscopy), agents used in induction and postoperative analgesia, use of blood, blood product and vasopressor are recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Above 18 years;
  • Patients who have undergone obesity surgery;
  • ASA 2-3 patients;
  • Patients who have received written informed consent;

排除标准

  • Patients under the age of 18;
  • Patients refusing to participate in the study;
  • Patients under emergency conditions;
  • Earlier laryngeal and tracheal surgery;
  • allergies to lidocaine;
  • Patients with FEV1 / FVC below 60%

结局指标

主要结局

Evaluation of postoperative atelectasis in bariatric surgery patients

时间窗: Up to 20 minutes in postoperative care unit

Postoperative atelectasis develops in patients undergoing laparoscopic bariatric surgery under anesthesia.After the operation a researcher will perform lung ultrasonography postoperative at minute 5. reseracher will detect 6 region of each lung totally 12 regions. the researcher will record the modified and original lung ultrasonography scores (LUS score) of the patients. LUS Score is a scoring system to eveluate atelectasis of lung and scores 1-3 points for each region (min score 0 max score 36)

次要结局

未报告次要终点

研究者

发起方
Kocaeli Derince Education and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

EMİNE YURT

Principal Investigator

Kocaeli Derince Education and Research Hospital

研究点 (2)

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