Lung Recruitment in Laparoscpic Surgery

NCT06221449 | Completed

• 1 other identifier: 7/2023ANET14
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Atelectasis, Postoperative

Keywords

laparoscopic, atelectasis, recruitment maneuver,

Outcome Measures

Primary Outcomes (1)

• Incidence of atelectasis

  incidence

  one hour

Secondary Outcomes (4)

• Lung ultrasound score

  one day

• Blood pressure ( millimetre Mercury)

  Two hour

• Heart rate

  Two hour

• Hospital length of stay

  One day

Study Arms (3)

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)

Procedure: Positive end expiratory pressure

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.

Procedure: Positive end expiratory pressure

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 .

Procedure: Positive end expiratory pressure

Interventions

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.

Group (I) Control group:(31 patients); Group (II) Sustained inflation group (SI): (31 patients); Group (III) Stepwise PEEP increasing: (31 patients)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia University

Shibīn al Kawm, Egypt

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Interventions

Positive-Pressure Respiration

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: comparison

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 24, 2024
• Study Start: February 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: May 15, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-10

Locations

EG (1)