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Preventing oxygen desaturation during bronchoscopy in patients with COPD comparing two oxygenation methods

Preventing oxygen desaturation during bronchoscopy using high flow oxygen vs standard management in COPD patients – PROSA 2 Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN18159882
Enrollment
600
Registered
2022-02-17
Start date
2021-11-08
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchoscopy in COPD patients Respiratory

Interventions

Patients will be randomized to either receive conventional oxygen by nasal cannula (control group) or high flow oxygen during sedation for bronchoscopy (HFNO/Intervention group)

Sponsors

University Hospital of Basel
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age =18 years 2. Informed Consent as documented signature 3. Clinical indication for bronchoscopy 4. Prior diagnosis of COPD according to the GOLD criteria

Exclusion criteria

Exclusion criteria: 1. Patients intubated at screening time 2. Bronchoscopy via tracheostomy tube 3. Patients requiring intubation for procedure 4. Prior enrolment in an intervention study within the last 30 days 5. Inability or contraindications to undergo the investigated intervention (i.e. active nasal bleeding; recent nasal surgery; base of skull defect or fracture) 6. Patients with oxygen saturation below 88% while breathing room air 7. Patient with hypercapnic respiratory failure (pCO2 > 6.5kPa) or other indications for non-invasive ventilation for bronchoscopy

Design outcomes

Primary

MeasureTime frame
Cumulative hypoxemia time, defined as oxygen saturation <90%, during sedation for bronchoscopy measured using pulse oximetry

Secondary

MeasureTime frame
Oxygen saturation, and therefore hypoxemia, will be measured with pulse oximetry. The partial pressure of carbon dioxide will be monitored using capnography. 1. Percentage of patients experiencing any hypoxemia, defined as 60 sec, defined as <90%, during bronchoscopy 3. Duration of hypoxemia, defined as <88%, during bronchoscopy 4. Lowest oxygen saturation during bronchoscopy 5. Average oxygen saturation during bronchoscopy 6. Number of episodes of hypoxemia, defined as <90%, during bronchoscopy 7. Maximal transcutaneous carbon dioxide (tcCO2) during bronchoscopy 8. Average tcCO2 during bronchoscopy 9. Maximal increase of tcCO2 from baseline during bronchoscopy 10. Occurrence of complications, including need for intubation, non-invasive ventilation, cardiac arrest 11. Results will be also analysed by type of bronchoscopic procedures 12. Analysis of patient comfort during examination using a questionnaire

Countries

Germany, Switzerland

Contacts

Public ContactDaiana Stolz
Daiana.Stolz@usb.ch+41 612654422

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026