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

NCT07383129 | Active Not Recruiting

• 1 other identifier: MD-462-2025
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Lung Collapse

Outcome Measures

Primary Outcomes (1)

• Proportion of radiological lung re-expansion at day 5.

  Assessed t via chest X-ray comparison (pre/post-intervention), defining success as ≥50% reduction in atelectasis opacity/area for partial collapse or full re-aeration for complete collapse. Captures therapeutic efficacy post-bronchoscopy (Group A immediate) vs. conventional care (Group B day 5), aligning with trial power on LOS reduction. (312 chars)

  12 month

Study Arms (2)

early broncoscopic intervention

EXPERIMENTAL

patients with acute lung collapse receive Patients with acute lung collapse receive early flexible bronchoscopy in addition to standard pediatric intensive care management.

Procedure: bronchoscope

conventional management

ACTIVE COMPARATOR

patients with acute lung collapse receive Patients with acute lung collapse receive conventional intensive care unit protocol without early broncoscopy

Other: chest physiotherapy and suction

Interventions

bronchoscope PROCEDURE

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)

early broncoscopic intervention

chest physiotherapy and suction OTHER

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.

conventional management

Eligibility Criteria

• Age: 1 Month - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Radiological evidence of partial or complete lung collapse (PICU admission or during stay).
• Intubated, on non-invasive ventilation, or high velocity oxygen.

You may not qualify if:

• obstructive collapse from endobronchial foreign body or tissue. Extrabronchial compression (tumor, lymphadenopathy, pleural effusion/pneumothorax).
• Bronchoscopy contraindications: severe refractory hypoxemia, hemodynamic instability, uncorrected coagulopathy.
• Musculoskeletal causes (e.g., scoliosis) or congenital lung diseases (e.g., lobar emphysema).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine Cairo University

Cairo, 11562, Egypt

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Interventions

Bronchoscopes; Suction

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Endoscopes; Diagnostic Equipment; Equipment and Supplies; Surgical Equipment; Drainage; Surgical Procedures, Operative

Study Officials

• fatma samy, masters

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 3, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

EG (1)