Effectiveness of Ultrasound-guided Lung Ventilation in Determining the Optimum Inspiratory Pressure in Pediatric Patients

NCT ID: NCT06188169

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-15
• Study Completion Date: 2023-08-12

Brief Summary

This study aimed to show the Effectiveness of Ultrasound-guided Lung Ventilation to determine the appropriate level of inspiratory pressure sufficient to provide adequate pulmonary ventilation with the resolution of the atelectatic lung.

Detailed Description

Respiratory physiology is different in young children, especially in neonates and infants, from that of older children and adults. Neonates and infants have immature respiratory control, weak respiratory muscles, different airways, lung mechanics and higher basal metabolic oxygen requirements. Appreciating these distinctive respiratory characteristics in young children is necessary to formulate suitable anesthetic plans for the safe conduct of anesthesia as respiratory-related morbidity and mortality occur even in healthy children.

Atelectasis is a side effect of general anesthesia which can be found in all types of interventions and patients of all ages. The reported incidence of anesthesia-induced atelectasis in children varies from 12 to 42% in sedated and non-intubated patients and from 68 to 100% in children with general anesthesia with tracheal intubation or laryngeal mask.

Such lung collapse causes arterial blood oxygenation to decline during and after anesthesia. Although anesthesia-induced atelectasis resolves spontaneously in children with American Society of Anesthesiology's (ASA) physical status classification I to II after minor surgical procedures, this entity may persist in the postoperative period in high-risk children undergoing complex surgeries. In the latter population, atelectasis potentially increases the risk for ventilator-induced lung injury and could be associated with postoperative pulmonary complications.

Atelectasis and poorly ventilated lung areas appear during general anesthesia in adults as well as in children. It is of concern that collapsed lung tissue reduces lung compliance and causes venous admixture and arterial oxygenation impairment. Despite its high prevalence during anesthesia, bedside diagnosis of atelectasis remains challenging. Anesthesia-induced atelectasis is commonly small and thus mostly invisible on standard chest radiographs. In contrast, it can easily be diagnosed by tomographic imaging techniques such as computed tomography or magnetic resonance imaging (MRI). However, these latter are clinically impractical, expensive, time-consuming, and with harmful exposition to x-ray.

Sonography is a simple, non-invasive, and radiation-free methodology that has increased daily practice usage. Lung sonography (LUS) plays an important role in diagnosing pulmonary diseases in children, including obstructive and compressive atelectasis of different origins. Just as in adults, LUS could identify children needing a recruitment maneuver to re-expand their lungs and help optimize ventilator treatment during anesthesia. LUS could also identify critically ill children with a high risk for developing pulmonary complications due to residual atelectasis after surgery.

A prospective, randomized, double-blind study in the Second Affiliated Hospital and Yuying Children Hospital of Wenzhou Medical University showed that an inspiratory pressure of 12 cm H2O was sufficient to provide adequate ventilation with a lower occurrence of gastric insufflation during induction of general anesthesia in paralyzed Chinese children aged from 2 to 4 years old.

Many studies used LUS to determine the optimum positive end-expiratory pressure (PEEP), yet no previous studies used LUS to determine the best inspiratory pressure (IP) for pressure controlled ventilation. So, this study aimed to determine the appropriate level of inspiratory pressure sufficient to provide adequate pulmonary ventilation with the resolution of anesthesia-induced lung atelectasis using real-time ultrasonography in paralyzed children.

Conditions

Pediatric Lung Atelectasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Group A = C-PCV received conventional pressure-controlled ventilation

Inspiratory pressure will be adjusted to achieve an expired tidal volume of 7 ml/Kg; the respiratory rate will be adjusted to achieve an end ETCO2 at 32-35 mmHg, inspiratory to expiratory ratio at 1:2, PEEP at 4 cm H2O, and FiO2 at 0.5. No further adjustment in IP will be made throughout the surgery. LUS will be performed at the same fixed four-time interval as Group-B. Anesthesiologist will not do any interventions to the atelectatic areas in this group.

Group Type: EXPERIMENTAL

Increasing the inspiratory pressure if atelectasis detected by US

Intervention Type: PROCEDURE

The study used US to detect presence of lung atelectasis under mechanical ventilation in pediatrics. Inspiratory pressure increased gradually with continuous monitoring by lung US to minimize the atelectasis as possible.

Group B = US-PCV: received ultrasound-guided pressure-controlled ventilation

Initial IP will be ten cmH2O, PEEP 4 cmH2O with a 0.5 inspired oxygen fraction, and RR 12 breaths/min. Then under ultrasound guidance, a stepwise increase in inspiratory pressure from 10 cmH2O by 2 cmH2O increments every 5 min until the atelectasis disappeared on ultrasound (progression from lung collapse to B lines to normal lung image). The IP will be fixed at this level, and RR will be adjusted to maintain an EtCO2 at 32-35 mmHg. The maximum airway pressure will be limited to 35 cmH2O.

Group Type: ACTIVE_COMPARATOR

Increasing the inspiratory pressure if atelectasis detected by US

Intervention Type: PROCEDURE

The study used US to detect presence of lung atelectasis under mechanical ventilation in pediatrics. Inspiratory pressure increased gradually with continuous monitoring by lung US to minimize the atelectasis as possible.

Interventions

Increasing the inspiratory pressure if atelectasis detected by US

The study used US to detect presence of lung atelectasis under mechanical ventilation in pediatrics. Inspiratory pressure increased gradually with continuous monitoring by lung US to minimize the atelectasis as possible.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Children's age starting from 5 to 12 years.
• Genders eligible for the study: both sexes.
• ASA I-II.
• They were scheduled for elective Abdomino-pelvic surgery lasting > 1.5 hours duration.

Exclusion Criteria

• Parent refusal
• Emergency cases
• Laparoscopic surgeries
• Acute respiratory disease, pulmonary or lung diseases
• Lung consolidation score ≥ 2 before intubation
• Morbid obesity

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Omnia Yahia El Sayed Kamel

Lecturer of anesthesiology and surgical ICU and pain management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sherif Soaida, MD

Role: STUDY_DIRECTOR

Cairo University

Hany Mohammed, MD

Role: STUDY_DIRECTOR

Cairo University

Mohamed Mohamed, MD

Role: STUDY_DIRECTOR

Cairo University

Omnia Kamel, MD

Role: STUDY_DIRECTOR

Cairo University

Locations

Abul Rish Pediatric Hospital

Giza, الجيزة, Egypt

Countries

Egypt

Other Identifiers

US-guided Lung ventilation

Identifier Type: -

Identifier Source: org_study_id