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

T

Tanta University

Status

Enrolling

Conditions

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

Treatments

Other: Ultrasound-guided lung recruitment
Other: Individualized PEEP
Other: Fixed PEEP

Study type

Interventional

Funder types

Other

Identifiers

NCT06306820
36264MS257/7/2023

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

3 to 8 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 3 patient groups

Control group
Active Comparator group
Description:
Patients will receive a fixed positive end-expiratory pressure (PEEP) of 5 cmH2O.
Treatment:
Other: Fixed PEEP
Ultrasound group
Experimental group
Description:
Patients will receive ultrasound -guided lung recruitment.
Treatment:
Other: Ultrasound-guided lung recruitment
PEEP IND group
Experimental group
Description:
Patients will receive individualized positive end-expiratory pressure (PEEP).
Treatment:
Other: Individualized PEEP

Trial contacts and locations

1

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Central trial contact

Reham M Rezk, MBBCH

Data sourced from clinicaltrials.gov

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