Preventing oxygen desaturation during bronchoscopy in patients with COPD comparing two oxygenation methods
| ISRCTN | ISRCTN18159882 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18159882 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | University Hospital of Basel |
| Funder | Universitätsspital Basel |
- Submission date
- 22/11/2021
- Registration date
- 17/02/2022
- Last edited
- 04/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Normally, oxygen is administered during bronchoscopy to maintain the oxygen content in the blood during the examination. For years, we have routinely administered oxygen via nasal cannulae. The nasal HighFlow is now a new method of oxygen application and additionally of ventilation support. The flow rates of this a humidified and heated air stream can vary between 2 - 80 l/min. The use of nasal HighFlow is expected to result in a more constant oxygen saturation during lung imaging and also in an accompanying respiratory support and thus reduction of your oxygen consumption during the examination. In the end we would like to find out whether the use of nasal HighFlow can reduce fluctuations in oxygen saturation and an increase in carbon dioxide (pCO2) in the blood. In addition, we are interested in patient comfort and tolerability of this mode of administration.
Who can participate?
Adults with a previous diagnosis of COPD and a clinical indication for a bronchoscopy.
What does the study involve?
Every participant will randomly receive either oxygen via nasal cannula or nasal HighFlow via the associated nasal cannula during the bronchoscopy. During the examination, they will be closely monitored for blood pressure, pulse, oxygen saturation, and your carbon dioxide level. Afterwards the participants answer a short questionnaire in which they are asked to briefly answer how they felt about the examination.
What are the possible benefits and risks of participating?
There is no direct benefit to participating other than helping future patients undergoing bronchoscopies using the most suitable oxygenation method. With every bronchoscopy there are certain risks. Participating in this study will not increase the risks during the bronchoscopy other than a possible dehydration, irritation or bleeding tendency of the nasal mucosa.
Where is the study run from?
University Hospital of Basel (Switzerland)
When is the study starting and how long is it expected to run for?
March 2021 to December 2023
Who is funding the study?
University Hospital of Basel (Switzerland)
Who is the main contact?
Prof. Daiana Stolz, Daiana.Stolz@usb.ch
Vivian Suarez Domenech, vivian.suarezdomenech@usb.ch
Contact information
Public
University Hospital of Basel
Petersgraben 4
Basel
4031
Switzerland
| Phone | +41 612654422 |
|---|---|
| Daiana.Stolz@usb.ch |
Scientific
University Hospital Basel
Clinic of Respiratory Medicine and Pulmonary Cell Research
Petersgraben 4
Basel
4031
Switzerland
| Phone | +41 61 328 69 17 |
|---|---|
| vivian.suarezdomenech@usb.ch |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Investigator-initiated prospective randomized controlled superiority multicenter study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Preventing oxygen desaturation during bronchoscopy using high flow oxygen vs standard management in COPD patients – PROSA 2 Study |
| Study acronym | PROSA 2 |
| Study objectives | The purpose of this study is to evaluate whether oxygen delivery using HFNO during sedation for bronchoscopy will improve oxygenation in patients with COPD compared to conventional oxygen by nasal cannula. We hypothesise that a 25% decrease in the cumulative hypoxemia time during sedation for bronchoscopy could be achieved using HFNO. |
| Ethics approval(s) | Approved 22/10/2021, Ethics Committee Northwestern and Central Switzerland (Hebelstrasse 53, 4056 Basel, Switzerland; +41 (0)61 268 13 50; eknz@bs.ch), ref: 2021-01718 |
| Health condition(s) or problem(s) studied | Bronchoscopy in COPD patients |
| Intervention | 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) |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Cumulative hypoxemia time, defined as oxygen saturation <90%, during sedation for bronchoscopy measured using pulse oximetry |
| Key secondary outcome measure(s) |
Oxygen saturation, and therefore hypoxemia, will be measured with pulse oximetry. The partial pressure of carbon dioxide will be monitored using capnography. |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 600 |
| Total final enrolment | 605 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 08/11/2021 |
| Date of final enrolment | 31/12/2023 |
Locations
Countries of recruitment
- Germany
- Switzerland
Study participating centres
Petersgraben 4
Basel
4031
Switzerland
Freiburg
79106
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/ or analysed during the current study are available from the corresponding author on reasonable request. (Daiana.Stolz@usb.ch) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
04/12/2024: Contact details updated.
12/12/2023: The total final enrolment was added.
07/03/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 28/02/2023 to 31/12/2023.
2. The overall end date was changed from 28/02/2023 to 31/12/2023.
3. The intention to publish date was changed from 30/06/2023 to 31/12/2024.
4. A contact was added.
5. The plain English summary was updated to reflect these changes.
07/01/2022: Trial's existence confirmed by Ethics Committee Northwestern and Central Switzerland.
