ClinicalTrials.gg
Not yet recruitingNCT07442708Updated Mar 2, 2026

Segmental Lung Recruitment: a Randomized Controlled Trial

An interventional study of Segmental lung recruitment and Conventional lung recruitment in Segmental Lung Atelectasis, sponsored by Clinical Hospital Center Rijeka. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-02.

Sponsored by Clinical Hospital Center Rijeka · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study compares two ways of reopening collapsed parts of the lung in patients on a ventilator.

In one group, doctors use a small camera (bronchoscope) to guide air pressure directly to the blocked part of the lung. In the other group, increased air pressure is applied to the whole lung using the ventilator.

Patients are carefully monitored to ensure safety.

Read the detailed description

This study will compare two lung recruitment strategies in mechanically ventilated patients with segmental atelectasis.

In the experimental group, patients will undergo bronchoscopy-guided targeted segmental recruitment using endobronchial bloker. A flexible bronchoscope will be introduced through the endotracheal tube and advanced under direct visualization to the affected lung segment. The endobronchial blocker will be positioned to temporarily block the segmental bronchus, creating a closed system. Sustained positive pressure of 30 cmH₂O will be applied directly to the atelectatic segment for 30 minutes, while standard ventilator settings will be maintained for the remainder of the lung. Continuous monitoring of oxygen saturation, heart rate, blood pressure, and end-tidal carbon dioxide will be maintained. The maneuver will be immediately discontinued if oxygen saturation decreases by more than 10%, systolic blood pressure decreases by more than 20%, or heart rate changes by more than 20% from baseline values.

In the control group, patients will receive a conventional whole-lung recruitment maneuver. Continuous positive airway pressure (CPAP) of 40 cmH₂O will be applied to the entire respiratory system for 40 seconds using the ventilator. Monitoring and safety criteria will be identical to those used in the experimental group, and the maneuver will be discontinued if predefined thresholds are exceeded.

All patients will receive lung-protective mechanical ventilation according to current guidelines. Tidal volumes will be maintained at 6-8 mL/kg predicted body weight, plateau pressures will be limited to less than 30 cmH₂O, and positive end-expiratory pressure (PEEP) will be adjusted according to FiO₂-PEEP tables. Permissive hypercapnia will be accepted provided arterial pH remains above 7.20.

The primary outcomes will focus on safety and will include the incidence of clinically significant desaturation (oxygen saturation decrease greater than 5% from baseline) and hemodynamic instability (systolic blood pressure decrease greater than 20 mmHg or need for vasopressor dose escalation) during and within 30 minutes after the maneuver.

Secondary outcomes will include changes in respiratory parameters measured at baseline, 24 hours, and 48 hours after the intervention. These parameters will include the PaO₂/FiO₂ ratio, static respiratory system compliance, driving pressure, plateau pressure, and PEEP. Arterial blood gas analysis will be performed at baseline, 1 hour, 24 hours, and 48 hours to assess pH, PaO₂, PaCO₂, bicarbonate, and base excess.

Clinical outcomes will include duration of mechanical ventilation following the maneuver, length of stay in the intensive care unit, duration of ward treatment after ICU discharge, in-hospital mortality, and 28-day all-cause mortality.

All patients will undergo contrast-enhanced chest computed tomography. Lung parenchyma will be segmented using 3D Slicer software to quantify total lung volume and non-ventilated (pathologic) lung regions. The proportion of non-ventilated lung tissue relative to total lung volume will be calculated. A change greater than 15% in the proportion of non-ventilated lung between baseline and follow-up scans will be considered clinically significant.

Venous blood samples will be collected at baseline, 24 hours, and 48 hours. Serum concentrations of interleukin-2 and interleukin-8 will be measured using ELISA assays. Samples will be analyzed in duplicate, and assay variability will be less than 10%.

02

Conditions studied

  • Segmental Lung Atelectasis

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Keywords

  • : Lung atelectasis; Segmental lung recruitment; Mechanical ventilation; Intensive care unit; Recruitment maneuvers
03

In context

Pulmonary Atelectasis

377 studies on the registry are indexed under Pulmonary Atelectasis; 93 are open to participants now.

This study's planned enrollment of 20 is below the median of 60 across 268 interventional studies indexed under Pulmonary Atelectasis.

Browse Pulmonary Atelectasis studies →

Lead sponsor

Clinical Hospital Center Rijeka is the lead sponsor of 20 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • treatment in ICU, presence of radiologically or clinically confirmed pulmonary atelectasis during ICU treatment, requirement for mechanical ventilation

Exclusion criteria

Exclusion Criteria:

  • primary or secondary lung
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Segmental lung recruitment

    Patients will undergo bronchoscopy-guided targeted segmental lung recruitment via endobronchial blocker. Flexible bronchoscope will be introduced through the endotracheal tube and advanced under direct visualization to the affected lung segment. The endobronchial blocker will be positioned to temporarily occlude the segmental bronchus, creating a closed system. Sustained positive pressure of 30 cmH₂O will be applied directly to the atelectatic segment for 30 minutes, while standard ventilator settings will be maintained for the remaining lung tissue.

    Procedure: Segmental lung recruitment

  • Active comparator
    Control group

    Patients in the control group will receive standard recruitment maneuvers using continuous positive airway pressure applied for a short, sustained period at a level consistent with conventional clinical practice. This approach will reflect the commonly used recruitment strategy in routine care.

    Procedure: Conventional lung recruitment

Interventions

  • ProcedureSegmental lung recruitment

    Patients will undergo bronchoscopy-guided targeted segmental lung recruitment via endobronchial blocker. Flexible bronchoscope will be introduced through the endotracheal tube and advanced under direct visualization to the affected lung segment. The endobronchial blocker will be positioned to temporarily occlude the segmental bronchus, creating a closed system. Sustained positive pressure of 30 cmH₂O will be applied directly to the atelectatic segment for 30 minutes, while standard ventilator settings will be maintained for the remaining lung tissue.

  • ProcedureConventional lung recruitment

    Patients in the control group received standard recruitment maneuvers consisting of continuous positive airway pressure (CPAP) of 40 cmH₂O applied to the entire respiratory system for 40 seconds. This approach represents the conventional recruitment strategy used in clinical practice.

06

What researchers measure

Primary outcomes

  1. Safety profile

    The primary safety outcomes will be the incidence of clinically significant desaturation and hemodynamic instability during and within 30 minutes following the recruitment.

    Time frame: From enrollment 72 hours

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Protic A, Bura M, Juricic K. A 23-year-old man with left lung atelectasis treated with a targeted segmental recruitment maneuver: a case report. J Med Case Rep. 2020 Jun 24;14(1):77. doi: 10.1186/s13256-020-02409-6. PubMed 32576293 ↗
  • Protic A, Bura M, Sustic A, Brusic J, Sotosek V. Segmental Lung Recruitment in Patients with Bilateral COVID-19 Pneumonia Complicated by Acute Respiratory Distress Syndrome: A Case Report. Medicina (Kaunas). 2023 Jan 11;59(1):142. doi: 10.3390/medicina59010142. PubMed 36676766 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2026; primary completion for Mar 2026, 1 month later.

Of 152 non-industry interventional studies with no phase under Pulmonary Atelectasis, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 24. This study's planned 1 month is below that.

Counting every sponsor, half of 154 studies reached it within 12 months; a quarter within 5 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 24, 2026
First posted
Mar 2, 2026
StartEst.
Feb 25, 2026
Primary completionEst.
Mar 25, 2026
CompletionEst.
Apr 15, 2026
Last update
Mar 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07442708
Lead sponsor
Clinical Hospital Center Rijeka
Responsible party
Matej Bura (MD, Clinical Hospital Center Rijeka) — Principal investigator
First posted
Mar 2, 2026
Start date
Feb 25, 2026 (estimated)
Primary completion
Mar 25, 2026 (estimated)
Completion
Apr 15, 2026 (estimated)
Last update
Mar 2, 2026

Study contacts

Matej Bura, MD
Contact
matej.bura@hotmail.com
00385917387967

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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