Bronchoscopic Airway Clearance for Improving Lung Aeration in Mechanically Ventilated Patients With Atelectasis
Effect of Bedside Flexible Bronchoscopy-Guided Airway Clearance on Lung Aeration in Mechanically Ventilated Patients With Atelectasis: A Multicenter Randomized Controlled Trial
The goal of this clinical trial is to learn whether bedside flexible bronchoscopy-guided airway clearance can improve lung aeration in adult patients who are receiving invasive mechanical ventilation and have atelectasis with a high airway secretion burden.
The main questions it aims to answer are:
Does bedside flexible bronchoscopy-guided airway clearance reduce the proportion of nonaerated lung tissue from baseline to day 5? Does this treatment improve other lung aeration measures, respiratory mechanics, arterial blood gas parameters, pulmonary infection score, ventilator-free days, intensive care unit length of stay, and safety outcomes?
Researchers will compare usual airway care plus bedside flexible bronchoscopy-guided airway clearance with usual airway care alone to see if bronchoscopy-guided airway clearance improves lung aeration and clinical outcomes.
Participants will be randomly assigned to one of two groups. Participants in the usual care group will receive standard airway management, which may include airway suctioning, postural drainage, humidification, chest physiotherapy, and other routine respiratory care. Participants in the bronchoscopy group will receive the same usual care, plus bedside flexible bronchoscopy-guided airway clearance when predefined criteria for high airway secretion burden are met.
Participants will have clinical assessments during the study, including chest imaging, respiratory mechanics measurements, arterial blood gas tests, pulmonary infection score assessment, and safety monitoring. The main assessment will compare quantitative chest computed tomography findings at baseline and day 5 to evaluate changes in nonaerated lung tissue.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Mengyuan Shen, MD
- Telefonnummer: +8615996997839
- E-post: Smy0116tu@163.com
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Age 18 years or older
- Receiving invasive mechanical ventilation for at least 48 hours
- Presence of atelectasis confirmed by chest computed tomography, chest X-ray, or lung ultrasound
- High airway secretion burden, defined as requiring airway suctioning at least twice per hour during the previous 8 hours
- Written informed consent obtained from the participant or legally authorized representative
Exclusion Criteria:
- Expected duration of artificial airway maintenance less than 5 days
- Untreated tension pneumothorax Known or suspected aspiration
- Active intrapulmonary hemorrhage
- Severe dysfunction of other organs with expected short-term mortality within 7 days or need for palliative care
- Any other condition judged by the medical team to make the participant unsuitable for the study
- Informed consent not obtained
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Usual Airway Care
|
Usual airway care may include airway suctioning, postural drainage, chest physiotherapy, mechanical airway clearance techniques, humidification and heating of inhaled gas, cuff pressure monitoring, and timely clearance of airway secretions according to routine clinical practice.
|
|
Eksperimentell: Bronchoscopy-Guided Airway Clearance
|
Bedside flexible bronchoscopy-guided airway clearance will be performed through the artificial airway in mechanically ventilated participants.
The procedure will be used to inspect the tracheobronchial tree and remove retained airway secretions or mucus plugs by targeted suctioning.
Small-volume saline lavage may be used when secretions are thick or difficult to remove.
The intervention will be performed in addition to usual airway care when predefined criteria for high airway secretion burden are met.
After the procedure, ventilator settings will be restored according to the study protocol and the participant's clinical condition.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Percent Change in CT-assessed Nonaerated Lung Percentage From Baseline to Day 5
Tidsramme: Baseline to Day 5
|
Baseline to Day 5
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percent Change in CT-assessed Normally Aerated Lung Percentage From Baseline to Day 5
Tidsramme: Baseline to Day 5, with chest CT performed within 24 hours of each time point
|
Baseline to Day 5, with chest CT performed within 24 hours of each time point
|
|
|
Change in static respiratory system compliance from baseline to Day 5
Tidsramme: Baseline to Day 5
|
Static respiratory system compliance will be measured under controlled mechanical ventilation.
The change from baseline to Day 5 will be calculated as the Day 5 value minus the baseline value.
|
Baseline to Day 5
|
|
Change in driving pressure from baseline to Day 5
Tidsramme: Baseline and Day 5
|
Driving pressure will be calculated as plateau pressure minus positive end-expiratory pressure.
The change from baseline to Day 5 will be calculated as the Day 5 value minus the baseline value.
|
Baseline and Day 5
|
|
Change in plateau pressure from baseline to Day 5
Tidsramme: Baseline and Day 5
|
Plateau pressure will be recorded during mechanical ventilation.
The change from baseline to Day 5 will be calculated as the Day 5 value minus the baseline value.
|
Baseline and Day 5
|
|
Change in PaO2/FiO2 ratio from baseline to Day 5
Tidsramme: Baseline and Day 5
|
Baseline and Day 5
|
|
|
Ventilator-free days within 28 days after randomization
Tidsramme: From randomization to Day 28
|
Ventilator-free days are defined as the number of days alive and free from invasive mechanical ventilation during the first 28 days after randomization.
Patients who die before Day 28 will be assigned zero ventilator-free days.
Patients who remain on invasive mechanical ventilation for 28 days or longer will also be assigned zero ventilator-free days.
For patients successfully liberated from invasive mechanical ventilation and alive at Day 28, ventilator-free days will be calculated as 28 minus the number of days receiving invasive mechanical ventilation.
|
From randomization to Day 28
|
|
All-cause mortality within 28 days after randomization
Tidsramme: From randomization to Day 28
|
All-cause mortality will be defined as death from any cause occurring within 28 days after randomization.
|
From randomization to Day 28
|
|
Length of stay in the intensive care unit
Tidsramme: From randomization to ICU discharge or death, assessed up to 28 days
|
From randomization to ICU discharge or death, assessed up to 28 days
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Ling Liu, PHD, Zhongda Hospital, School of Medicine, Southeast University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BRONCO-CLEAR Trial
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .