Evaluation of the Effect of Perioperative Recruitment Maneuver Practice on Lung Ultrasound Score and Mechanical Power in Pediatric Patients

NCT07294560 | Not Yet Recruiting

• 1 other identifier: 1408545
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Pulmonary atelectasis is common during general anesthesia and increases the risk of hypoxemia, especially in pediatric patients. PEEP and recruitment maneuvers (RM) are effective in preventing atelectasis. Lung ultrasound is practical for diagnosis. Mechanical power refers to the amount of energy delivered to the lung by the ventilator; excessive mechanical power can cause lung injury. Limiting mechanical power may reduce postoperative complications. This study aimed to determine the effectiveness of recruitment maneuvers in preventing atelectasis using lung ultrasound during the intraoperative period, to examine the relationship between lung ultrasound scores and mechanical power, and to demonstrate the effect of recruitment maneuvers on postoperative pulmonary complications. This study is based on the hypothesis that "The recruitment maneuver reduces perioperative atelectasis and the development of related complications, and lung ultrasound can be used to detect this. The lung ultrasound score also decreases in patients with reduced mechanical force." It will be prospectively applied to pediatric patients aged 1-14 years who will undergo surgery in the operating rooms of Cerrahpaşa Medical Faculty. Patients included in the study will be prospectively randomized into 3 groups. The randomization performed using the sealed opaque envelope method.All patients will be ventilated in VG-Pressure guaranteed mode. Tidal volume will be calculated as 6-8 ml/kg of ideal body weight. GROUP 1: Fixed PEEP: 5 cmH2O, GROUP 2: PEEP: 5 cmH2O, 5 cycles, recruitment maneuver with plateau P\<35 cm H2O and vital capacity x2. GROUP 3: PEEP: 5 cmH2O, 5 cycles of recruitment maneuvers will be performed in the right and left lateral decubitus position before extubation with P\<35 cmH2O and vital capacity x2. Lung ultrasound will be performed before induction (1), 5 minutes after intubation (2), before extubation (3), and finally 5 minutes after extubation(4). Each hemithorax will be divided into 6 regions, and lung scores will be recorded. At 5 minutes after intubation and every hour there after, PeakP, PlateauP, DeltaP, Compliance, Driving Pressures, and Mechanical Work calculations will be recorded before and after the maneuver in the group undergoing the recruitment maneuver.

Conditions

Postoperative Pulmonary Atelectasis; Pediatric Surgery; Postoperative Pulmonary Complications

Keywords

recruitment maneuver; pediatric recruitment maneuver; PEEP; mechanical power; mechanical work; compliance; atelectasis

Outcome Measures

Primary Outcomes (2)

• Lung Ultrasound Score

  The lung ultrasound score will be calculated and recorded before induction, 5 minutes after intubation, before extubation, and 5 minutes after extubation. Lung ventilation loss can be assessed with the LUS Score. This assessment is performed on a total of 12 surfaces, divided by the anterior and posterior axillary lines on the thoracic wall, in the upper and lower parts of the anterior, lateral, and posterior regions. In this scoring system, a score between 0 and 3 is assigned to each of these surfaces. The total score ranges from 0 to 36, and higher scores indicate more severe ventilation loss.

  perioperative

• Mechanical Power

  Mechanical power calculated using airway pressure, tidal volume, respiratory rate and PEEP parameters to quantify ventilator-induced mechanical energy delivered to the lungs. Mechanical power = RR x TV x (PIP - \[(Pplat - PEEP) x 0.5\]) x 0.098

  perioperative

Secondary Outcomes (1)

• postoperative pulmonary complication

  postoperative 24 hours

Study Arms (3)

GROUP 1

NO INTERVENTION

Fixed PEEP: 5 cm H2O

GROUP 2

ACTIVE COMPARATOR

PEEP: 5 cm H2O, 5 cycles, recruitment maneuver will be performed with pre-extubation plateau P \< 35 cm H2O and vital capacity x 2

Other: recruitment maneuver

GROUP 3

ACTIVE COMPARATOR

PEEP: 5 cm H2O, 5 cycles of recruitment maneuvers will be performed in the right-left lateral decubitus position before extubation with plateauP \< 35 cm H2O and vital capacity x 2.

Other: right and left lateral decubitus position recruitment maneuvers

Interventions

recruitment maneuver OTHER

PEEP: 5 cmH2O, 5 cycles, recruitment maneuver with plateau P\<35 cm H2O and vital capacity x2.

GROUP 2

right and left lateral decubitus position recruitment maneuvers OTHER

PEEP: 5 cmH2O, 5 cycles of recruitment maneuvers will be performed in the right and left lateral decubitus position before extubation with P\<35 cmH2O and vital capacity x2.

GROUP 3

Eligibility Criteria

• Age: 1 Year - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged 1-14 years with
• ASA score of 1-3
• who had surgery in the operating rooms of Cerrahpaşa Medical Faculty during the study period
• surgical duration was at least 2 hours

You may not qualify if:

• ASA score of 4
• defined lung disease (patients using medication due to asthma and having 2 emergency visits within 1 year)
• prematurity (\< 36 weeks gestational age / bronchopulmonary dysplasia)
• cystic fibrosis
• diagnosed syndromic disease
• congenital cardiac disease
• abnormal chest X-ray
• chest wall deformity
• or history of previous chest surgery

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine

Istanbul, Bakırköy, 34153, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Atelectasis; Patient Compliance

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Elif Keskin, Medical Doctor

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elif Keskin, Medical Doctor

CONTACT

902124143000; elif.keskin1@iuc.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Elif Keskin, Medical Doctor, Istanbul University - Cerrahpasa

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: February 15, 2026
• Primary Completion: April 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)