NCT07383129

Brochoscopic Intervention Versus Conventional Management in Acute Lung Collapse in the Pediatric Intensive Care Unit

Early Brochoscopic Intervention Versus Conventional Management in the Treatment of Acute Lung Collapse Among Critically Ill Children in the Pediatric Intensive Care Unit

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 1 Month – 13 Years
• Healthy volunteers: Not accepted

Summary

This prospective RCT at Cairo University Children Hospitals enrolls critically ill pediatric patients (intubated, NIV, or post-extubation) with lung atelectasis unresponsive to 48 hours of conventional recruitment. Randomization uses computer-generated sealed envelopes: Group A receives bronchoscopy with active inflation; Group B gets suctioning, chest physiotherapy ± cough assist. Crossover permitted after 5 days failure or if unsafe; pulmonologist assesses. Data covers personal history (age, sex, weight, residency) and clinical details (PICU diagnosis, symptoms/duration). Strengths include bias-minimizing allocation, ethical flexibility, and standardized baselines. Suggested expansions: ventilation parameters (mode, FiO2, PEEP), atelectasis scoring (X-ray/US), outcomes (P/F ratio, LOS, VAP), and safety metrics for power (targeting 20-30% non-response) to align with PALICC-2. (612 chars)

Detailed description

This is a prospective, randomized controlled trial (RCT) enrolling critically ill patients intubated , on non-invasive ventilation or post-extubation with lung atelectasis admitted at pediatrics emergency and intensive care units, Cairo University Children Hospitals, identified by treating medical team. Patient randomization will be done by a computer-based generation and serial sealed enveloped numbers was taken for the patients. Assessment will be done by a pediatric pulmonologist. All patients will be subjected to routine initial conventional lung inflation and recruitment maneuvers. For those non inflatable lungs within 48 hours of conservative measures, they will be divided into two groups, group A: patients will undergo bronchoscopic intervention and active lung inflation, and group B: managed using conventional therapies, suctioning, chest physiotherapy, with or without the aid of a cough assisted device , in case of no clinical or radiological improvement after 5 days this is considered failure of conventional methods patients in this group may take a chance to do bronchoscopy (Oh's Intensive Care Manual, 9th ed., 2023). Whenever the randomly assigned therapy is considered to be failed or unsafe to be continued, the treating physician will discontinue the randomization and continue with the appropriate treatment modality according to the patients need.

Conditions

• Lung Collapse

Interventions

Type	Name	Description
PROCEDURE	bronchoscope	This RCT stands out by randomizing refractory pediatric atelectasis (post-48h failed recruitment) to fiberoptic bronchoscopy with active inflation vs. optimized conventional care (suctioning, physiotherapy ± cough assist) with crossover. Unique Aspects: Targets true refractory cases after standardized recruitment, unlike diagnostic FFB series (mucus plugs \~50%) or elective bronchoscopy. Uses flexible scope for therapeutic inflation, not rigid removal, CPAP-endobrochial in CHD, dornase instillation, or unstructured physio alone. Differentiation: 5-day pulmonologist-assessed radiographic/clinical endpoint tests superiority absent in pediatric RCTs; powers ventilation-free days/VAP. Isolates bronchoscopy in mixed PICU etiologies. (578 chars)
OTHER	chest physiotherapy and suction	Conventional Management Endotracheal suctioning, chest physiotherapy (percussion/postural drainage), ± cough assist device (positive/negative pressure cycles). recruitment maneuvers; assessed day 5 for clinical/radiographic response.

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-10-01
• Completion: 2026-12-01
• First posted: 2026-02-03
• Last updated: 2026-02-03

Locations

1 site across 1 country: Egypt