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

NCT ID: NCT03557905

Last Updated: 2023-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-06
• Study Completion Date: 2023-01-30

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.

Conditions

Intraoperative Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group I

Patients will receive recruitment maneuver (RM) followed by decremental PEEP titration 1min. after establishment of mechanical ventilation and after documented lung re-collapse at an FiO2 of 0.5. .

Group Type: ACTIVE_COMPARATOR

RM 0.5

Intervention Type: DEVICE

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

Group II

Patients will receive recruitment maneuver (RM) followed by decremental PEEP titration 1min. after establishment of mechanical ventilation and after documented lung re-collapse at an FiO2 of 0.3.

Group Type: ACTIVE_COMPARATOR

RM 0.3

Intervention Type: DEVICE

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.

Interventions

RM 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.

Intervention Type: DEVICE

RM 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.

Intervention Type: DEVICE

Other Intervention Names

RM; RM

Eligibility Criteria

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.-

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Hala Saad Abdel-Ghaffar

Professor of anesthesia and intensive care, faculty of medicine, Assiut university.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hala S Abdelghaffar, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of anesthesia, faculty of medicine, Assiut university, Egypt.

Locations

Assiut university main hospital, Microsurgery unit

Asyut, Assiut Governorate, Egypt

Countries

Egypt

Other Identifiers

17200202

Identifier Type: -

Identifier Source: org_study_id