Clinical Trials Directory

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UnknownNCT06306820

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

Ultrasound Guided Recruitment Manauvere Versus Individualized Positive End Expiratory Pressure in Pediatric Patients Undergoing Laparoscopic Abdominal Surgery; A Prospective Randomized Controlled Study.

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
120 (estimated)
Sponsor
Tanta University · Academic / Other
Sex
All
Age
3 Years – 8 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
OTHERFixed PEEPPatients will receive a fixed positive end-expiratory pressure (PEEP) of 5 cmH2O throughout the surgical procedure.
OTHERUltrasound-guided lung recruitmentPatients 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.
OTHERIndividualized PEEPPatients 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.

Timeline

Start date
2024-03-12
Primary completion
2024-08-01
Completion
2024-08-01
First posted
2024-03-12
Last updated
2024-03-13

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT06306820. Inclusion in this directory is not an endorsement.