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Postoperative Pulmonary ComplicationsLUS RM PEEPNCT07294560

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

A study testing recruitment maneuver and right and left lateral decubitus position recruitment maneuvers in people with Postoperative Pulmonary Complications and Postoperative Pulmonary Atelectasis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 year to 14 years
What is being tested?
recruitment maneuver and right and left lateral decubitus position recruitment maneuvers
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Feb 2026to 15 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • abnormal chest X-ray
  • chest wall deformity
  • or history of previous chest surgery

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Elif Keskin, Medical Doctor contact

902124143000

elif.keskin1@iuc.edu.tr

Turkey (Türkiye)1 site
  • Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine

    Istanbul, Bakırköy, 34153

    Elif Keskin, Medical doctor, 902124143000, elif.keskin1@iuc.edu.tr

    Elif Keskin, Medical Doctor

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Effect of Perioperative Recruitment Maneuver Practice on Lung Ultrasound Score and Mechanical Power in Pediatric Patients; A Prospective Randomized Study

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.

Read more

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.

Read the detailed description

Pulmonary atelectasis refers to incomplete expansion of the alveoli and terminal bronchioles. Atelectasis impairs oxygenation of the blood and reduces lung compliance. Pulmonary atelectasis is common in patients undergoing general anesthesia. The pediatric patientgroup is more sensitive to hypoxemia due to lower functional residual capacity and increased metabolic requirements compared to adults. Therefore, preventing and detecting atelectasis is important. Recruitment maneuvers open collapsed alveoli, increase gas exchange, and improve oxygenation. Lung ultrasound is a fast, simple, non-invasive, and radiation-free technique for diagnosing anesthesia-induced atelectasis. Mechanical work is a recently defined ventilation parameter. This concept represents the energy transferred by the ventilator to the respiratory system per unit time. Part of this energy may directly affect lung tissue, causing ventilator-induced lung injury. Mechanical work is calculated based on a combination of parameters such as tidal volume, respiratory rate, driver pressure, and peak pressure. Mechanical work is a comprehensive measure that reflects the static and dynamic components of these variables together. In intensive care patients, both driving pressure and mechanical power have been shown to be associated with morbidity and mortality. However, in the pediatric patient group, the effect of mechanical power during the intraoperative period on postoperative pulmonary complications has not been sufficiently investigated. Limiting intraoperative mechanical power may reduce the risk of postoperative complications.This study aimed to determine the effectiveness of the recruitment maneuver in preventing atelectasis using lung ultrasound during the intraoperative period, to examine the relationship between the lung ultrasound score and mechanical power, and to demonstrate the effect of the recruitment maneuver on postoperative pulmonary complications.

During the study period, patients aged 1-14 years who underwent surgery in the operating rooms of Cerrahpaşa Medical Faculty, with an ASA score of 1-3, and a surgical duration of at least 2 hours will be included in the study. Patients with an ASA score of 4 or defined lung disease (patients using medication due to asthma and having made 2 emergency visits within 1 year), prematurity (< 36 weeks gestation/bronchopulmonary dysplasia), cystic fibrosis, diagnosed syndromic disease, congenital cardiac disease, abnormal chest X-ray, chest wall deformity, or history of previous chest surgery will be excluded from the study. All patients will be ventilated in VG-Pressure guaranteed mode, Tidal volume will be calculated as ideal body weight x 6-8 ml/kg GROUP 1: Fixed PEEP: 5 cm H2O, GROUP 2: PEEP: 5 cm H2O, 5 cycles, recruitment maneuver will be performed with pre-extubation plateau P < 35 cm H2O and vital capacity x 2

. GROUP 3: 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.

This study will be performed pre-induction (1), 5 minutes after intubation (2), pre-extubation (3), and finally 5 minutes after extubation (4). In the lung ultrasonographic examinations performed, each hemithorax will be divided into 6 regions, and pleural shift, A-line, Air Bronchogram, B score, and Consolidation score will be evaluated at each of the two Plaps points in terms of B score and consolidation score.

Lung scores will be calculated and recorded. Starting from the pre-induction period, at 5 minutes post-intubation and every hour thereafter, KAH, OAB, SpO2, FiO2, ETCO2, Peak P, Plateau P, Delta P, Compliance, driving pressures, mechanical power calculations, and values will be recorded.

Additionally, in groups where the recruitment maneuver is performed, pre- and post-maneuver values will be recorded. Additionally, in groups undergoing recruitment maneuvers, pre- and post-maneuver values will be recorded.

Mechanical power; MPvcv = RR x TV x (PIP - [(Pplat - PEEP) x 0.5]) x 0.098 Dynamic power : (TV x RR x [(Pplato + tPEEP) x 0.5) x 0.098 Driving force: (TV x RR x [ (Pplato - tPEEP) x 0.5] x 0.098 Mechanical Energy (0.098 (TV kg) (PIP -[(Pplato - PEEP) x 0.5] All patients will be premedicated with midazolam (0.05 -1 mg/kg) if vascular access is available, then taken to the operating room. After patients are taken to the operating room, standard monitoring will be performed (SPO2, ECG, and non-invasive blood pressure measurement). Following preoxygenation with 100% O2, induction will be performed with thiopental 5 mg/kg, propofol 2 mg/kg, fentanyl 2 mcg/kg, rocuronium 0.6 mg/kg. After tracheal intubation, the mechanical ventilator will be set to pressure-controlled mode with tidal volume: 8 ml/kg, PEEP: 5 cmH2O, FIO2: 40%, respiratory rate ETCO2: 35-45. Anesthesia maintenance will be provided with sevoflurane/oxygen. 2 mg/kg sugammadex will be used when waking patients. The Aldrete scoring system will be used for service transfer in the recovery unit.

Patients will be monitored for desaturation, fever, and oxygen needs during the 24-hour postoperative period, and findings will be recorded.

Being tested
recruitment maneuver, right and left lateral decubitus position recruitment maneuvers
Keywords
recruitment maneuver, pediatric recruitment maneuver, PEEP, mechanical power, mechanical work, compliance, atelectasis
Medical subject headings
Pulmonary Atelectasis, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • recruitment maneuverOther

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

  • right and left lateral decubitus position recruitment maneuversOther

    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.

Study groups in NCT07294560
Study groupRoleWhat they receive
GROUP 1No interventionFixed PEEP: 5 cm H2O
GROUP 2Active comparatorPEEP: 5 cm H2O, 5 cycles, recruitment maneuver will be performed with pre-extubation plateau P < 35 cm H2O and vital capacity x 2
Receives: Other: recruitment maneuver
GROUP 3Active comparatorPEEP: 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.
Receives: Other: right and left lateral decubitus position recruitment maneuvers

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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

    Measured: perioperative

Secondary outcomes (1)
  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.

    Measured: postoperative 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2025
  2. Study start15 Feb 2026 (estimated)
  3. Primary completion15 Apr 2026 (estimated)
  4. Study completion15 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07294560
Sponsor's protocol ID
1408545
Acronym
LUS RM PEEP
Status last verified
Feb 2026
First submitted
8 Dec 2025
Last updated
11 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing recruitment maneuver and right and left lateral decubitus position recruitment maneuvers in people with Postoperative Pulmonary Complications and Postoperative Pulmonary Atelectasis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elif Keskin, Medical Doctor (902124143000, elif.keskin1@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lung Ultrasound Score (time frame: perioperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.

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