跳至主要内容
临床试验/NCT06221449
NCT06221449已完成不适用

Effect of Lung Recruitment on Atelectasis in Lung-Healthy Patients Undergoing Laparoscopic Cholecystectomy

Menoufia University1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2024年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
93
试验地点
1
主要终点
Incidence of atelectasis

研究概览

简要总结

The goal of this clinical trial study is to assess the effectiveness of different methods of lung recruitment maneuver on the incidence of atelectasis in adults undergoing laparoscopic cholecystectomy surgery using lung ultrasound Participants will be divided into three groups as: Control group, sustained inflation group (SI) and Stepwise Positive end expiratory pressure increasing group(Third group). Each contains 31 patients.

Control Group = Keep parameters all through the procedure without any changing GROUP(SI) = After abdominal deflation, we will apply sustained inflation by adjusting Adjustible pressure Limiting valve 40 centimetres water on spontaneous mode, holding the bag for 30 second.

Third group = After abdominal deflation, we will apply stepwise Positive Pressure increasing by 2 centimetres water every 5 breathing cycles till reaching 12 centimetres water and keeping it till extubation, with a maximum airway pressure not exceeding 40 centimetres water.

详细描述

the effectiveness of different methods of lung recruitment maneuver on the incidence of atelectasis in adults undergoing laparoscopic cholecystectomy surgery using lung ultrasound Participants will be divided into three groups as: Control group, sustained inflation group (SI) and Stepwise POSITIVE pressure increasing group. Each contains 31 patients.

Control Group = Keep parameters all through the procedure without any changing GROUP(SI) = After abdominal deflation, The investigators will apply sustained inflation by adjusting Adjustible pressure valve 40 centimetres water spontaneous mode, holding the bag for 30 second.

Third group = After abdominal deflation, the investigators will apply stepwise POSITIVE pressure increasing by 2 centimeters water 5 breathing cycles till reaching 12 centimetres water and keeping it till extubation, with a maximum airway pressure not exceeding 40 centimetreswater.

During the entire procedure the transducer head will be placed over one point of the chest selected by the operator where the area of atelectasis was detected The probe will be placed in the atelectasis area.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
盲法
Double (Participant, Investigator)

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 healthy lungs
  • •Age between 18 and 65 years old
  • •Body mass index (BMI) <30 kg / m2
  • •Physical status I-II of the American Society of Anesthesiologists (ASA)
  • •Elective laparoscopic cholecystectomy.

排除标准

  • •Patient refusal
  • •Patients with preoperative ultrasound evidence of pulmonary atelectasis.
  • •Patients who will have conversion from laparoscopic to open surgery.
  • •Patients experiencing critical postoperative complications such as severe subcutaneous emphysema and pneumothorax.
  • •Patients with pulmonary, cardiac, and neuromuscular diseases and a corresponding surgical history and respiratory tract infections.

研究组 & 干预措施

Group (I) Control group:(31 patients)

Placebo Comparator

Patients will have controlled mechanical ventilation with these parameters (fixed Tidal Volume 6-8ml/Kg Ideal body weight - fixed fio2 0.5% - fixed POSITIVE end expiratory pressure 6 cm. water - fixed respiratory rate10-14 Respiratory rate /min)

干预措施: Positive end expiratory pressure (Procedure)

Group (II) Sustained inflation group (SI): (31 patients)

Active Comparator

Patients will have controlled mechanical ventilation then after abdominal deflation, sustained inflation for 30 second by applying pressure 40 centimetreswater, with 5 these parameters (fixed Tidal Volume 6-8ml/Kg Ideal bogy weight - fixed fio2 0.5% - fixed positive end expiratory pressure 6 cmH2O - fixed respiratory rate 10-14 per minute.

干预措施: Positive end expiratory pressure (Procedure)

Group (III) Stepwise PEEP increasing: (31 patients)

Active Comparator

Patients will have controlled mechanical ventilation, then after abdominal deflation gradual increasing in Positive end expiratory pressure 2 centimetres water every 5 respiratory cycle with maximum 10-12 centimetres water guided by hemodynamics & airway pressure not exceeding 40 centimetres water With these parameters (fixed Tidal Volume 6-8ml/Kg Ideal body weight - fixed fio2 0.5% -fixed respiratory rate10-14 .

干预措施: Positive end expiratory pressure (Procedure)

结局指标

主要结局

Incidence of atelectasis

时间窗: one hour

incidence

次要结局

  • Heart rate(Two hour)
  • Lung ultrasound score(one day)
  • Blood pressure ( millimetre Mercury)(Two hour)
  • Hospital length of stay(One day)

研究者

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

Amany Said Abdel Haleem

Lecturer

Menoufia University

研究点 (1)

Loading locations...

相似试验