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

Pediatric Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06306820
• Other study ID #: 36264MS257/7/2023
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2024
• Est. completion date: August 1, 2024

Study information

• Verified date: March 2024
• Source: Tanta University
• Contact: Reham M Rezk, MBBCH
• Phone: 00201013193723
• Email: rehamrezk95[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Laparoscopic Abdominal Surgery
• Pediatric Patients

Intervention

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

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	El-Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Lung ultrasound scores	Lung ultrasound scores to assess anesthesia-induced atelectasis and will be performed immediately after intubation, one hour after pneumoperitoneum, one hour after extubation, and 24 hours after extubation	24 hours after extubation
Secondary	Mean arterial blood pressure (MAP)	Mean arterial blood pressure (MAP) will be assessed before induction of anesthesia, immediately after intubation, after first recruitment Maneuvere (RM), one hour after pneumoperitoneum, after second recruitment Maneuvere (RM), and one hour after extubation.	One hour after extubation
Secondary	Heart rate	Heart rate (HR) will be assessed before induction of anesthesia, immediately after intubation, after first recruitment Maneuvere (RM), one hour after pneumoperitoneum, after second recruitment Maneuvere (RM), and one hour after extubation.	One hour after extubation
Secondary	Postoperative pulmonary complication	Early postoperative pulmonary complication in the first 24 hours postoperative.	24 hours postoperative