Ultrasound Guided Recruitment Manauvere Versus Individualized Positive End Expiratory Pressure in Pediatric Patients Undergoing Laparoscopic Abdominal Surgery

NCT ID: NCT06306820

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-12
• Study Completion Date: 2024-08-01

Brief Summary

The aim of this prospective randomized controlled study is to compare the effect of US-guided Recruitment Manauvere (RM) versus individualized positive end-expiratory pressure (PEEP) on oxygenation and preventing respiratory complications in pediatric patients undergoing laparoscopic abdominal surgeries.

Detailed Description

Atelectasis is among the most frequent postoperative pulmonary complications (PPCs) of general anesthesia with an incidence of between 68% and 100% in children. Atelectasis impairs gas exchange, thus causing hypoxemia and other respiratory disorders such as acute lung injury and pneumonia.

Pneumoperitoneum is another risk factor for perioperative atelectasis. It elevates the diaphragm and intra-abdominal pressure. In order to prevent atelectasis, applying positive end-expiratory pressure (PEEP) or an alveolar recruitment Maneuvere (RM) have shown beneficial effects.

Lung ultrasound (US) is a noninvasive, radiation-free, convenient, and reproducible bedside imaging modality for anesthesia-induced atelectasis in children.

Conditions

Ultrasound Guided Recruitment Manauvere; End Expiratory Pressure; Pediatric Patients; Laparoscopic Abdominal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control group

Patients will receive a fixed positive end-expiratory pressure (PEEP) of 5 cmH2O.

Group Type: ACTIVE_COMPARATOR

Fixed PEEP

Intervention Type: OTHER

Patients will receive a fixed positive end-expiratory pressure (PEEP) of 5 cmH2O throughout the surgical procedure.

Ultrasound group

Patients will receive ultrasound -guided lung recruitment.

Group Type: EXPERIMENTAL

Ultrasound-guided lung recruitment

Intervention Type: OTHER

Patients will receive ultrasound-guided lung before pneumoperitoneum, after pneumoperitoneum then once an hour, until the end of surgery. Alveolar recruitment will be conducted the same as that for the conventional manoeuvre with a simultaneous continuous ultrasound assessment if atalectasis is detected until no collapsed areas are visualized. When the collapsed lung areas are absent on the sonogram, positive end-expiratory pressure (PEEP) can no longer increase at this point. Subsequently, the pressure will be maintained for approximately 10 breaths.

PEEP IND group

Patients will receive individualized positive end-expiratory pressure (PEEP).

Group Type: EXPERIMENTAL

Individualized PEEP

Intervention Type: OTHER

Patients will receive individualized positive end-expiratory pressure (PEEP). After the first recruitment Maneuvere (RM), titration of PEEP will be performed by setting the initial PEEP to 5 cm H2O, then increasing PEEP according to the gradient of 2 cmH2O every 3 min, calculating static compliance (Cstat) according to the formula: \[Cstat = VT/Pplat - PEEP\] (Pplat = plateau pressure), then gradually increasing PEEP, until the calculated Cstat shows a downward trend, the we set its previous PEEP (corresponding to PEEP for high Cstat) as the optimal PEEP for this patient. The highest PEEP is limited to 15 cmH2O.

Interventions

Fixed PEEP

Patients will receive a fixed positive end-expiratory pressure (PEEP) of 5 cmH2O throughout the surgical procedure.

Intervention Type: OTHER

Ultrasound-guided lung recruitment

Patients will receive ultrasound-guided lung before pneumoperitoneum, after pneumoperitoneum then once an hour, until the end of surgery. Alveolar recruitment will be conducted the same as that for the conventional manoeuvre with a simultaneous continuous ultrasound assessment if atalectasis is detected until no collapsed areas are visualized. When the collapsed lung areas are absent on the sonogram, positive end-expiratory pressure (PEEP) can no longer increase at this point. Subsequently, the pressure will be maintained for approximately 10 breaths.

Intervention Type: OTHER

Individualized PEEP

Patients will receive individualized positive end-expiratory pressure (PEEP). After the first recruitment Maneuvere (RM), titration of PEEP will be performed by setting the initial PEEP to 5 cm H2O, then increasing PEEP according to the gradient of 2 cmH2O every 3 min, calculating static compliance (Cstat) according to the formula: \[Cstat = VT/Pplat - PEEP\] (Pplat = plateau pressure), then gradually increasing PEEP, until the calculated Cstat shows a downward trend, the we set its previous PEEP (corresponding to PEEP for high Cstat) as the optimal PEEP for this patient. The highest PEEP is limited to 15 cmH2O.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age from 3 to 8 years.
• Both sexes.
• American Society of Anesthesiologists (ASA) physical status I-II.
• Children scheduled for elective laparoscopic abdominal surgeries.

Exclusion Criteria

• Parental refusal.
• Bronchial asthma or any preexisting chest disease.
• Congenital deformity of the thoracic cage.
• Patients with a history of thoracic surgery.
• Cardiac, hepatic, or renal failure.
• Obese children with BMI at or above 95th percentile of the same age and sex.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Reham Mostafa Mostafa Rezk

Principal Investigator of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, El-Gharbia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Reham M Rezk, MBBCH

Role: CONTACT

rehamrezk95@gmail.com

00201013193723

Facility Contacts

Reham M Rezk, MBBCH

Role: primary

rehamrezk95@gmail.com

00201013193723

Other Identifiers

36264MS257/7/2023

Identifier Type: -

Identifier Source: org_study_id