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

NCT06306820 | Recruiting

• 1 other identifier: 36264MS257/7/2023
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Intraoperative oxygenation

  Intraoperative oxygenation which will be assessed by P/F ratio (the ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen P/F ratio will be assessed before induction of anesthesia, one hour after pneumoperitoneum, and after second recruitment Maneuvere (RM)

  One hour after second recruitment Maneuvere

Secondary Outcomes (4)

• Lung ultrasound scores

  24 hours after extubation

• Mean arterial blood pressure (MAP)

  One hour after extubation

• Heart rate

  One hour after extubation

• Postoperative pulmonary complication

  24 hours postoperative

Study Arms (3)

Control group

ACTIVE COMPARATOR

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

Other: Fixed PEEP

Ultrasound group

EXPERIMENTAL

Patients will receive ultrasound -guided lung recruitment.

Other: Ultrasound-guided lung recruitment

PEEP IND group

EXPERIMENTAL

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

Other: Individualized PEEP

Interventions

Fixed PEEP OTHER

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

Control group

Ultrasound-guided lung recruitment 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.

Ultrasound group

Individualized PEEP 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.

PEEP IND group

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

Central Study Contacts

Reham M Rezk, MBBCH

CONTACT

00201013193723; rehamrezk95@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: March 2, 2024
• First Posted: March 12, 2024
• Study Start: March 12, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)