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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-14
SponsorIstanbul University - Cerrahpasa

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • recruitment maneuver

    Other intervention

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

  • right and left lateral decubitus position recruitment maneuvers

    Other intervention

    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.

Treatment groups

78 Participants
are divided into 3 treatment groups
Group A: GROUP 1No intervention 0 interventions
Group B: GROUP 2Active comparator 1 intervention
Group C: GROUP 3Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
perioperative
2

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

Time frame
perioperative

Secondary outcomes

1

postoperative pulmonary complication

The secondary outcome is to compare the incidence of clinically significant postoperative pulmonary complications (atelectasis, decreased oxygen saturation, and need for postoperative respiratory support) between the groups.

Time frame
postoperative 24 hours

Other outcomes

Sponsors and contacts

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