Lung Recruitment in Laparoscpic Surgery

Not Applicable

Completed

• Conditions: Atelectasis, Postoperative
• Interventions: Procedure: Positive end expiratory pressure

• Registration Number: NCT06221449
• Lead Sponsor: Menoufia University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-12-19
• Study First Submitted QC: 2024-01-13
• Study First Posted: 2024-01-24
• Study Start: 2024-02-01
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-13
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Group (I) Control group:(31 patients)	Positive end expiratory pressure	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)
Group (III) Stepwise PEEP increasing: (31 patients)	Positive end expiratory pressure	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 .
Group (II) Sustained inflation group (SI): (31 patients)	Positive end expiratory pressure	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.

Primary Outcome Measures

Name	Time	Method
Incidence of atelectasis	one hour	incidence

Secondary Outcome Measures

Name	Time	Method
Heart rate	Two hour	Beat per minute
Lung ultrasound score	one day	0 no atelectasis with A lines; 1. multiple B lines; 2. white lung; 3. Lung consolidation
Blood pressure ( millimetre Mercury)	Two hour	Measurements
Hospital length of stay	One day	Duration of stay at hospital in hours

Trial Locations

Locations (1)

Menoufia University; 🇪🇬 Shibīn Al Kawm, Egypt