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Completed

NCT Number: NCT06221449

Lung Recruitment in Laparoscpic Surgery

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Menoufia University

Shibīn al Kawm, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Positive end expiratory pressure

Procedure

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.

Primary outcomes

  1. Incidence of atelectasis

    Time frame: one hour

    incidence

Secondary outcomes

  1. Lung ultrasound score

    Time frame: one day

    0 no atelectasis with A lines

    • multiple B lines
    • white lung
    • Lung consolidation
  2. Blood pressure ( millimetre Mercury)

    Time frame: Two hour

    Measurements

  3. Heart rate

    Time frame: Two hour

    Beat per minute

  4. Hospital length of stay

    Time frame: One day

    Duration of stay at hospital in hours

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 24, 2024
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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