Skip to content

Ultrasonographic Assessment of Lung Recruitment Maneuvers in Children Undergoing Lengthy Microsurgery Operations

Ultrasonographic Assessment of Lung Recruitment Maneuvers in Pediatric Patients Undergoing Lengthy Microsurgery Operations

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03557905
Acronym
RM
Enrollment
44
Registered
2018-06-15
Start date
2018-08-06
Completion date
2023-01-30
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraoperative Complications

Brief summary

The aim of this study will be to explore the clinical value of ultrasonic monitoring in the diagnosis of anesthesia-induced atelectasis, the assessment of the effects of lung recruitment, the best positive end-expiratory pressure (PEEP) after RM and in the detection of the point of lung re-collapse after RM in pediatric patients undergoing lengthy microsurgery operations using two levels of intraoperative FIO2 (0.5 VERSUS 0.3).

Detailed description

* To maximize the benefits, minimize the drawbacks and assess the adequacy of the recruitment maneuver; adequate monitoring at the bedside is essential. Several methods have been proposed, including measuring end-expiratory lung volume or pulmonary compliance, volumetric capnography, oxygenation indices, electrical impedance tomography, computerized tomography and lung ultrasound. * For lung CT examination patients must be transported out to the radiation unit, which carries risk of transfer, high cost, and radiation exposure. The oxygenation method which is the most commonly used, but it is necessary to repeat arterial blood collection many times, which is cumbersome and expensive. * Using lung ultrasound (LUS) as real-time guidance during the recruitment maneuver has gained popularity recently owing to its' easy applicability and non-invasive nature. Sonography is a radiation-free methodology which plays an important role in diagnosing pulmonary diseases in children, including obstructive and compressive atelectasis of different origins. Furthermore, lung ultrasound has shown reliable sensitivity and specificity for the diagnosis of anaesthesia-induced atelectasis in children. * LUS can identify children needing a recruitment maneuver to re-expand their lungs and help optimize ventilator treatment during anesthesia.

Interventions

DEVICERM 0.5

Patients will receive recruitment maneuver (RM) followed by decremental PEEP titration 1min. after establishment of mechanical ventilation and after documented lung re-collapse.

DEVICERM 0.3

The patient will be ventilated with volume control mode with tidal volume 6 ml/kg, PEEP 3 cmH2O, an inspiratory expiratory ratio of 1:1.5, respiratory rate 20-25 breaths per minute depending on the patient's age and FiO2 of 0.3.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Ventilator adjustments, lung recruitment, PEEP titration and ultrasonographic assessments will be done by well-trained investigators not involved in data collection. The surgeon, the parents or legal guardians and the data collection personell will be blinded to the patients' group assignment.

Intervention model description

To explore the clinical value of ultrasonic monitoring in the diagnosis of anesthesia-induced atelectasis, the assessment of the effects of lung recruitment, the best positive end-expiratory pressure (PEEP) after RM and in the detection of the point of lung re-collapse after RM in pediatric patients undergoing lengthy microsurgery operations using two levels of intraoperative FIO2 (0.5 VERSUS 0.3).

Eligibility

Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

* Age: 2-12 years old. * ASA physical status classification I-II. * Undergoing lengthy microsurgery operations * and requiring endotracheal intubation and mechanical ventilation for more than 4 hours.-

Exclusion criteria

* ASA Physical status classification \>II. * Thoracic or abdominal surgery. * Preexisting lung disease. * Pre-operative chest infection or abnormal chest US findings. * Cardiac patients.-

Design outcomes

Primary

MeasureTime frameDescription
Lung Areation Score10 minutes after induction of anesthesialung Areation Score calculated on first lung ultrasound.For a given thoracic area, points will be allocated to the worst LUS pattern observed and video clips of each region examined will be stored. The sum of the points obtained in all the 12 lung areas will define the LUS aeration score, ranging from 0 to 36 for the whole thorax. This score is inversely proportional to the degree of lung aeration.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026