Lung Recruitment in Laparoscpic Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Atelectasis, Postoperative
• Intervention / Treatment: Procedure: Positive end expiratory pressure

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 Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Shibīn Al Kawm, Egypt
    • Menoufia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group (I) Control group:(31 patients); 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)	Procedure: Positive end expiratory pressure; The patients will be divided into three groups: Control group:(31 patients); Patients will have controlled mechanical ventilation with these parameters (fixed Tidal Volume 6-8ml/Kg IBW - fixed fio2 0.5% - fixed PEEP 6 cmH2O - fixed respiratory rate10-14 RR/min) II) Group (II) Sustained inflation group (SI): (31 patients); Patients will have controlled mechanical ventilation then after abdominal deflation, sustained inflation for 30 second by applying pressure 40 cmH2O, with 5 these parameters (fixed Tidal Volume 6-8ml/Kg IBW - fixed fio2 0.5% - fixed PEEP 6 cmH2O - fixed respiratory rate 10-14 RR/min) III) Group (III) Stepwise PEEP increasing: (31 patients); Patients will have controlled mechanical ventilation, then after abdominal deflation gradual increasing in PEEP 2 cmH2O every 5 respiratory cycle with maximum 10-12 cmH2O guided by hemodynamics & airway pressure not exceeding 40 cmH2O.
Active Comparator: Group (II) Sustained inflation group (SI): (31 patients); 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.	Procedure: Positive end expiratory pressure; The patients will be divided into three groups: Control group:(31 patients); Patients will have controlled mechanical ventilation with these parameters (fixed Tidal Volume 6-8ml/Kg IBW - fixed fio2 0.5% - fixed PEEP 6 cmH2O - fixed respiratory rate10-14 RR/min) II) Group (II) Sustained inflation group (SI): (31 patients); Patients will have controlled mechanical ventilation then after abdominal deflation, sustained inflation for 30 second by applying pressure 40 cmH2O, with 5 these parameters (fixed Tidal Volume 6-8ml/Kg IBW - fixed fio2 0.5% - fixed PEEP 6 cmH2O - fixed respiratory rate 10-14 RR/min) III) Group (III) Stepwise PEEP increasing: (31 patients); Patients will have controlled mechanical ventilation, then after abdominal deflation gradual increasing in PEEP 2 cmH2O every 5 respiratory cycle with maximum 10-12 cmH2O guided by hemodynamics & airway pressure not exceeding 40 cmH2O.
Active Comparator: Group (III) Stepwise PEEP increasing: (31 patients); 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 .	Procedure: Positive end expiratory pressure; The patients will be divided into three groups: Control group:(31 patients); Patients will have controlled mechanical ventilation with these parameters (fixed Tidal Volume 6-8ml/Kg IBW - fixed fio2 0.5% - fixed PEEP 6 cmH2O - fixed respiratory rate10-14 RR/min) II) Group (II) Sustained inflation group (SI): (31 patients); Patients will have controlled mechanical ventilation then after abdominal deflation, sustained inflation for 30 second by applying pressure 40 cmH2O, with 5 these parameters (fixed Tidal Volume 6-8ml/Kg IBW - fixed fio2 0.5% - fixed PEEP 6 cmH2O - fixed respiratory rate 10-14 RR/min) III) Group (III) Stepwise PEEP increasing: (31 patients); Patients will have controlled mechanical ventilation, then after abdominal deflation gradual increasing in PEEP 2 cmH2O every 5 respiratory cycle with maximum 10-12 cmH2O guided by hemodynamics & airway pressure not exceeding 40 cmH2O.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of atelectasis	incidence	one hour

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): May 1, 2024
• Study Completion (Actual): May 15, 2024

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: January 13, 2024
• First Posted (Actual): January 24, 2024

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 13, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: laparoscopic, atelectasis, recruitment maneuver,
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: 7/2023ANET14

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No