NCT06770179

Effect of Ultrasound-assisted Lung Recruitment Maneuver on Preventing Perioperative Atelectasis

ENROLLING BY INVITATION NA Last updated 13 January 2025

What this trial tests

NA trial testing recruitment maneuver in Undergoing Surgery in 78 participants. Enrolling by invitation.

Timeline

25 November 2024

Primary endpoint
28 February 2025

3 March 2025

Quick facts

Lead sponsor	Istanbul University - Cerrahpasa
Phase	NA
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	78
Start date	25 November 2024
Primary completion	28 February 2025
Estimated completion	3 March 2025
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• recruitment maneuver
• positional recruitment maneuver

Conditions studied

• Undergoing Surgery — all drugs for Undergoing Surgery →
• Perioperatif Atelectasis — all drugs for Perioperatif Atelectasis →

Sponsor

Istanbul University - Cerrahpasa

Who can join

Adults 1 to 14, any sex, with Undergoing Surgery or Perioperatif Atelectasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is based on the hypothesis that recruitment maneuver reduces perioperative atelectasis and associated complications, and lung ultrasonography can be used to detect this.

Patients aged 1 to 14 years with an ASA physical status classification of 1 to 3 and undergoing surgical procedures with a minimum duration of 2 hours will be included in the study.

Patients with an ASA physical status classification of 4, including those with defined pulmonary diseases (e.g., asthma requiring medication and having had two emergency visits in the past year), prematurity ( \<36 weeks gestation / bronchopulmonary dysplasia), cystic fibrosis, diagnosed syndromic conditions, congenital cardiac diseases, abnormal chest X-rays, chest wall deformities, or a history of previous thoracic surgery, as well as those undergoing laparoscopic surgery, will be excluded from the study.

All patients will be premedicated with midazolam (0.05-1 mg/kg) if intravenous access is established, prior to transfer to the operating room. Upon arrival, standard monitoring will be initiated, including SpO2, ECG, and non-invasive blood pressure measurements. Following preoxygenation with 100% oxygen, induction will be performed using thiopental 5 mg/kg or propofol 2 mg/kg, fentanyl 2 mcg/kg, and rocuronium 0.6 mg/kg. After tracheal intubation, mechanical ventilation will be configured in pressure-controlled mode with a tidal volume of 8 ml/kg, PEEP of 5 cmH2O, FIO2 of 40%, and a respiratory rate adjusted to maintain ETCO2 within the range of 35-45 mmHg. Anesthesia maintenance will be achieved with sevoflurane and oxygen. During emergence, sugammadex 2 mg/kg will be administered as a neuromuscular reversal agent. The Aldrete scoring system will be employed for assessing patient readiness for transfer to the recovery unit.

GROUP 1: PEEP will be set at 5 cmH2O, and no recruitment maneuver will be performed.

GROUP 2: PEEP will be set at 5 cmH2O. Prior to extubation, a recruitment maneuver will be conducted with a Plato P max : 35 cmH2O, delivering 6 breaths at a vital capacity of 2 times, with an I/E ratio of 1:1.

GROUP 3: PEEP will be set at 5 cmH2O. Prior to extubation, a recruitment maneuver will be performed with a Plato P max : 35 cmH2O, delivering 3 breaths in the left lateral decubitus position and 3 breaths in the right lateral decubitus position, at a vital capacity of 2 times, with an I/E ratio of 1:1.

Lung ultrasonography will be performed at the following time points: 1) before induction, 2) at the 5-minute mark after induction, 3) before the recruitment maneuver, and 4) at the 5-minute mark after extubation.

The lungs will be assessed by dividing each hemithorax into 6 regions. Evaluation will include pleural sliding, A-lines, air bronchograms, B-score, and consolidation score. Both PLAPS points will be evaluated for B-score and consolidation score.

From the beginning of the operation, the following parameters will be recorded hourly: heart rate (HR), arterial blood pressure (ABP), oxygen saturation (SpO2), fraction of inspired oxygen (FIO2), end-tidal CO2 (ETCO2), peak pressure (Ppeak), PLATO pressure, delta pressure, and compliance.

During the postoperative 24-hour period, the following will be documented: temperature, desaturation, oxygen requirement, and the need for additional radiological investigations.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.