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

NCT07383129 — Not applicable, Active not recruiting, 36 participants, Cairo University

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

RegistryNCT07383129, acronym picu
StatusActive not recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment36 (Estimated)
SponsorCairo University (Other)
ConditionsLung Collapse
Interventionsbronchoscope, chest physiotherapy and suction (Procedure, other)
Datesstart 2025-10-01, primary completion 2026-10-01 (estimated), completion 2026-12-01 (estimated), first posted 2026-02-03, last updated 2026-02-03
Locations1 site in Egypt

Related Papers Related Patents Related Grants Related Experts
All trials for Lung Collapse All trials of bronchoscope All trials of chest physiotherapy and suction

-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)

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
early broncoscopic interventionExperimentalProcedure: bronchoscopepatients with acute lung collapse receive Patients with acute lung collapse receive early flexible bronchoscopy in addition to standard pediatric intensive care management.
conventional managementActive comparatorOther: chest physiotherapy and suctionpatients with acute lung collapse receive Patients with acute lung collapse receive conventional intensive care unit protocol without early broncoscopy
  • 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)
  • 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.

+Outcome measures

Primary outcomes

  • Proportion of radiological lung re-expansion at day 5. [12 month]: 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)

+Eligibility

Sex: All, ages: 1 Month to 13 Years

Inclusion Criteria:

* Radiological evidence of partial or complete lung collapse (PICU admission or during stay).

Intubated, on non-invasive ventilation, or high velocity oxygen.

Exclusion Criteria:

* 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).

+Locations (1)

FacilityCityCountryStatus
Faculty of Medicine Cairo UniversityCairoEgypt

+Investigators

  • fatma samy, masters, Principal investigator, Cairo University