Ultrasound-guided Lung Recruitment Maneuvers for Postoperative Pediatric Atelectasis

NCT05777018 | Completed DMC

• 1 other identifier: atelectasis in pediatrics
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

In anesthetized children, the incidence of lung collapse with episodes of hypoxemia is high. Diaphragmatic dysfunction induced by general anesthesia is one of the most important factors in the genesis of regional losses of lung aeration. The mass of the abdominal organs pushes the diaphragm cranially compressing the lungs in the most dependent areas. Such regional lung collapse may range from a slight loss of aeration to complete atelectasis.

Conditions

Atelectasis; Postoperative Complications; Recruitment; Pediatric; Abdominal Surgery

Outcome Measures

Primary Outcomes (1)

• The incidence of atelectasis

  The incidence of atelectasis in post anesthesia care unit

  postoperative first 2 hours

Study Arms (2)

conventional

ACTIVE COMPARATOR

Procedure: conventional recruitment maneuvers

ultrasound-guided

ACTIVE COMPARATOR

Procedure: ultrasound-guided recruitment maneuvers

Interventions

conventional recruitment maneuvers PROCEDURE

The recruitment maneuver will be performed at 3 predefined time points: 5 minutes after induction of GA (T2), 5 minutes after insufflation of the capnoperitoneum (T3), After the end of surgery and before recovery from anesthesia (T4). by pressure controlled mode starting with an airway pressure of 15 cmH2O the subsquently changed ( decrease or increase) to provide targeted tidal volume according to each patient, maintaining end-tidal carbon dioxide between 35 to 45 mmHg with 5 cmH2O increments in PEEP until a peak pressure of 30 cmH2O will be achieved. Each PEEP level will be maintained for 5 s. The peak airway pressure will be maintained for 10 s or five breaths and subsequently reduced, followed by maintenance with the previous ventilator settings

Also known as: control

conventional

ultrasound-guided recruitment maneuvers PROCEDURE

* Ultrasound guided maneuver will be performed at T2, T3 and T4. * The recruitment maneuver will be performed under ultrasound guidance until no collapsed lung area is visible. The strategy to increase the airway pressure will be the same as that for the conventional maneuver, although the maximal pressure limit will be 40 cmH2O. The Recruitment maneuvers (RM) will be started searching the pressure level at which the consolidation pattern disappears and progressive lung re-aeration is observed and will be recorded for all patients (the lung's opening pressure).(14) Lung ultrasound examination will be performed every 5 cmH2O increments in PEEP to detect the lung's opening pressure.

ultrasound-guided

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients scheduled for laparoscopic abdominal surgery
• American Society of anaesthesiologist class I \& II

You may not qualify if:

• Pre-existing cardiac disease.
• Morbidly obese patients according to age.
• Patients with previous thoracic or cardiac surgery.
• Upper or lower airway infection within 2 weeks before the surgery.
• Lung ultrasound abnormalities including patches, pneumothorax, and pleural effusion.
• Abnormal preoperative chest x-ray findings including atelectasis, pneumothorax, pleural effusion or pneumonia.
• Preoperative oxygen saturation measured by pulse oximetry (SpO2) of 96% or less on room air.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of medicine, Tanta university

Tanta, El Gharbyia, 31111, Egypt

Location

MeSH Terms

Conditions

Pulmonary Atelectasis; Postoperative Complications

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• hoda ezz

  tanta university, faculty of medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 20, 2023
• Study Start: December 1, 2022
• Primary Completion: July 30, 2023
• Study Completion: August 30, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)