Conventional Versus Ultrasound-guided Lung Recruitment Manoeuvre in Morbidly Obese Patients Underdoing Laparoscopic Bariatric Surgery: Prospective Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 4
- 主要终点
- the change of Lung Ultrasound Score
研究概览
简要总结
Lung ultrasonography is an easy-to-use, portable, non-invasive, visual, and non-radiative technique that has been widely used in clinical monitoring and diagnosis.
Many studies have demonstrated that pulmonary ultrasonography can evaluate the degree of aeration loss and diagnose atelectasis accurately by using a validated semiquantitative score in the perioperative period, and lung ultrasonic imaging can be conducive to confirming the effects of lung recruitment manoeuvres.
This clinical trial suggested that the use of ultrasound-guided recruitment maneuver in morbidly obese patients scheduled for laparoscopic bariatric surgery can improve the lung aeration, decrease the incidence of basal lung atelectasis, decrease the incidence of intraoperative& postoperative oxygen desaturation, and reduce the incidence of post operative pulmonary complications.
The aim of this prospective randomized clinical study is to compare the conventional recruitment manoeuvre and ultrasound-guided recruitment manoeuvre in morbidly obese patients scheduled for laparoscopic bariatric surgery.
详细描述
- This prospective randomized clinical double-blinded study will be carried out at Anesthesiology Department in Tanta University Hospitals for one year from August 2023 to August 2024 after approval from our institutional ethical committee. All enrolled patients will sign an informed written consent to participate in the study.
- Every patient will receive an explanation of the purpose of the study and have secret code number to ensure privacy and confidentiality, all given data will be used for scientific purposes only.
- Any unexpected risks encountered during the research will be cleared to the participants, as well as to the Ethical Committee on time. The risk at the study includes increased risk of bradycardia and hypotension that will be managed by adequate monitoring, atropine, IV fluids, and ephedrine.
-Patients will be randomly allocated in one of the two equal groups using a computer-generated table of random numbers to :-
• Conventional group (group C); 30 patients: Patients will be shifted to 100% Oxygen then; the recruitment maneuver will be performed by manual inflation with a pressure of 30 cmH2O for 30 seconds.
• Ultrasound-guided group (group US); 30 patients: Patients will be shifted to 100% Oxygen then; the recruitment maneuver will be performed under the direct real-time guidance of ultrasound if atelectasis (defined as LUS of ≥ 2 for any of the 12 regions) is present. This will be done by manual inflation with a pressure of 10 cmH2O for 10 seconds, increased 10 cmH2O every 10 seconds until no collapsed areas are visible on the ultrasound, the maximum airway pressure will be limited to 40 cmH2O. This could be repeated if needed.
-Anesthesia technique
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
- Double (Participant, Outcomes Assessor)
盲法说明
- The participants will be kept blind through the use of ultrasound assessment in both groups.
- Outcome assessors will be blinded as they will be anesthesia resident and nurse not participating in the study.
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult morbidly obese patients of BMI more than 40, scheduled for laparoscopic bariatric surgery
排除标准
- •Patient refusal
- •Patients with history of severe obstructive or restrictive pulmonary disease.
- •Patients with severe obstructive sleep apnea (OSA).
- •Presence of emphysematous lung bullae.
- •Decompensated cardiac disease (NYHA class 3 or 4).
- •Patients with uncontrolled hepatic or renal disorders.
结局指标
主要结局
the change of Lung Ultrasound Score
时间窗: 2 hours
Assessment of the changes in the lung ultrasound score
次要结局
- The incidence of atelectasis(2 hours)
- The incidence of intra-operative desaturation(3 hours)
研究者
Sameh Abdelkhalik Ahmed Ismaiel
Assistant Professor of Anesthesia and Intensive Care
Tanta University