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

NCT06770179 | Enrolling By Invitation

• 1 other identifier: E-83045809-604.01-904144
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Undergoing Surgery; Perioperatif Atelectasis

Keywords

perioperatif atelectasis; Recruitment maneuver; lung ultrasound

Outcome Measures

Primary Outcomes (2)

• B scores

  Each hemithorax will be divided into six regions using three longitudinal (parasternal, anterior axillary, and posterior axillary) and two transverse (1 cm above the nipple line and diaphragm) lines. Each region will be scanned sequentially from right to left, top to bottom, and front to back, with the probe perpendicular to the ribs. Pleural sliding, A-lines, air bronchograms, juxtapleural consolidation, and B-lines will be assessed. Additionally, B scores will be evaluated at two specific PLAPS points.

  Perioperative (Lung ultrasound will be performed four times on each patient: T1: Pre-induction T2: 5 minutes after induction T3: Pre-recruitment maneuver T4: 5 minutes after extubation.)

• Consolidation Scores

  Each hemithorax will be divided into six regions using three longitudinal (parasternal, anterior axillary, and posterior axillary) and two transverse (1 cm above the nipple line and diaphragm) lines. Each region will be scanned sequentially from right to left, top to bottom, and front to back, with the probe perpendicular to the ribs. Consolidation scores will be evaluated at two specific PLAPS points

  Perioperative ( Lung ultrasound will be performed four times on each patient: T1: Pre-induction T2: 5 minutes after induction T3: Pre-recruitment maneuver T4: 5 minutes after extubation.)

Secondary Outcomes (8)

• HR

  perioperative

• SpO₂

  perioperative

• MAP

  Perioperative

• ETCO2

  Perioperative

• Peak P

  Perioperative

Other Outcomes (1)

• Postoperative Complications

  Up to 24 Hours

Study Arms (3)

group 1

NO INTERVENTION

Patients in this group will receive a fixed PEEP of 5 cm H₂O during the perioperative period.

group 2

EXPERIMENTAL

In addition to the fixed PEEP of 5 cm H₂O, a recruitment maneuver will be performed at the end of the surgery.

Other: recruitment maneuver

group 3

EXPERIMENTAL

In addition to the fixed PEEP of 5 cm H₂O, a positional recruitment maneuver will be performed at the end of the surgery.

Other: positional recruitment maneuver

Interventions

recruitment maneuver OTHER

in the group 2, in addition to the fixed PEEP of 5 cm H₂O, a recruitment maneuver is planned at the end of the surgery. This will involve administering 6 breaths with VC × 2, I/E ratio of 1:1, and a plateau pressure of less than 35 cm H₂O, before extubation.

group 2

positional recruitment maneuver OTHER

In the third group, in addition to the fixed PEEP, a recruitment maneuver will be performed at the end of the surgery before extubation. This will involve administering 6 breaths with VC × 2, I/E ratio of 1:1, and a plateau pressure of less than 35 cm H₂O, with 3 breaths in the right lateral decubitus position and 3 breaths in the left lateral decubitus position

group 3

Eligibility Criteria

• Age: 1 Year - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged 1 to 14 years
• ASA scores of 1 to 3
• Minimum surgical duration of 2 hours.

You may not qualify if:

• Patients with an ASA score of 4,
• Defined lung diseases (such as those using medication for asthma and having a hospital visit within the past year)
• Prematurity ( bronchopulmonary dysplasia)
• Cystic fibrosis
• Diagnosed syndromic conditions
• Congenital cardiac disease
• Abnormal lung findings
• Chest wall deformities
• A history of chest surgery
• Those undergoing laparoscopic surgery

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

İstanbul Üniversitesi -Cerrahpaşa,Cerrahpaşa Tıp Fakültesi

Istanbul, 34000, Turkey (Türkiye)

Location

Study Design

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

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: January 13, 2025
• Study Start: November 25, 2024
• Primary Completion: February 28, 2025
• Study Completion: March 3, 2025
• Last Updated: January 13, 2025

Record last verified: 2025-01

Locations

TU (1)