Respiratory FailureRasecalNCT05964075
RASECAL-Bronchoscopic Ambusampler
An observational study of Respiratory Failure, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Prospective, multi-centre, open labelled, 1:1randomized controlled study. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Respiratory Failure
- How many people
- 207 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jan 2022to 10 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients requiring clinical bronchoscopy
Who may be able to join
- (All are required)
- Clinicians experienced in performing bronchoscopies (i.e. bronchoscopists should have performed a minimum 5 bronchoscopies in mechanically ventilated patients and a minimum of 5 bronchoscopies in a simulated or practice setting).
- Clinicians who have undergone the online product-training module for the use of the Ambu Bronchosampler, with self-certification documented.
- Clinicians who have simulated the online product training module using an Ambu Bronchosampler and Ambu Ascope4 a minimum of 5 times in a practice setting and have self-certified.
- Population
- Patients ≥ 18 years old
- Patients on mechanical ventilation with Acute respiratory failure for >4h
- Patients eligible for a clinically indicated bronchoscopy with fluid sampling. Patient information has been explained and verbal or written consent has been obtained
Who cannot join
- Investigators
- Investigators who have not completed product training in aScope BronchoSampler by online and hands-on from Ambu product specialists or an experienced user from the site.
- Investigators with experience in < 5 self-verified simulated fluid sampling procedures using the Ambu BronchoSampler 4.8.2 Population
- Clinician concern regarding safety of bronchoscopy
- Involved study personal not available to perform the procedure and enroll the patient
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Chelsea and Westminster Hospital NHSFT
London, SW10 0XD
About this study
Official title: A Randomized Controlled Trial to Assess the Safety and Efficiency of a Self-Contained Sampling Device /disposable Bronchoscope System Versus Usual SampLing Procedure.
Prospective, multi-centre, open labelled, 1:1randomized controlled study.
Read the detailed description
- Patients admitted to ICU with acute respiratory failure, requiring mechanical ventilation with, suspected or confirmed COVID-19.
- Patients admitted to ICU with acute respiratory failure due to a condition other than COVID-19, requiring mechanical ventilation.
- Conditions
- Respiratory Failure
- Medical subject headings
- Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of two sampling pots
Can the Ambu Bronchosampler improve safety versus usual standard care by reducing the risk of spillage or disconnection of the sampling system during a procedure?
Measured: 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start14 Jan 2022
- Primary completion10 Oct 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chelsea and Westminster NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damon 0 Foster, 0, Principal investigator, Chelsea and Westminster NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964075
- Sponsor's protocol ID
- RASECAL Study
- Acronym
- Rasecal
- Status last verified
- Dec 2024
- First submitted
- 18 Apr 2023
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Singh S, Chana S, Mcentee J, Agbontaen K, Athayde A, Creagh-Brown B, Valliani D, Carungcong J, Martins L, Costa P, Al Hindawi A, Grover V, Woods DR, Antcliffe DB, Smart C, Said H, Popescu M, Garfield B, Ong D, Cangliaosi M, Leal R, Russell C, Templeman V, Sissons A, Sokhi J, Christie L, Davies R. Randomised controlled trial to assess the safety and efficiency of a self-contained sampling device/disposable bronchoscope system versus usual sampling procedure (RASECAL). BMJ Open Respir Res. 2026 Aug 31;13(1):e004249. doi: 10.1136/bmjresp-2026-004249.
PubMed 42674806
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Assess the Safety and Efficiency of a Self-Contained Sampling Device /disposable Bronchoscope System Versus Usual SampLing Procedure.
- ClinicalTrials.gov ID
- NCT05964075
- Acronym / sponsor ID
- Rasecal / RASECAL Study
- Conditions
- Respiratory Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Chelsea and Westminster NHS Foundation TrustUniversity, hospital or other
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multi-centre, open labelled, 1:1randomized controlled study.
Detailed description
- Patients admitted to ICU with acute respiratory failure, requiring mechanical ventilation with, suspected or confirmed COVID-19.
- Patients admitted to ICU with acute respiratory failure due to a condition other than COVID-19, requiring mechanical ventilation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring clinical bronchoscopy
Key inclusion criteria (8 listed)
- (All are required)
- Clinicians experienced in performing bronchoscopies (i.e. bronchoscopists should have performed a minimum 5 bronchoscopies in mechanically ventilated patients and a minimum of 5 bronchoscopies in a simulated or practice setting).
- Clinicians who have undergone the online product-training module for the use of the Ambu Bronchosampler, with self-certification documented.
- Clinicians who have simulated the online product training module using an Ambu Bronchosampler and Ambu Ascope4 a minimum of 5 times in a practice setting and have self-certified.
- Population
Key exclusion criteria (5 listed)
- Investigators
- Investigators who have not completed product training in aScope BronchoSampler by online and hands-on from Ambu product specialists or an experienced user from the site.
- Investigators with experience in < 5 self-verified simulated fluid sampling procedures using the Ambu BronchoSampler 4.8.2 Population
- Clinician concern regarding safety of bronchoscopy
- Involved study personal not available to perform the procedure and enroll the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of two sampling pots
Time frame: 1month
Can the Ambu Bronchosampler improve safety versus usual standard care by reducing the risk of spillage or disconnection of the sampling system during a procedure?
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Derived from this study: PubMed 42674806Singh S, Chana S, Mcentee J, Agbontaen K, Athayde A, Creagh-Brown B, Valliani D, Carungcong J, Martins L, Costa P, Al Hindawi A, Grover V, Woods DR, Antcliffe DB, Smart C, Said H, Popescu M, Garfield B, Ong D, Cangliaosi M, Leal R, Russell C, Templeman V, Sissons A, Sokhi J, Christie L, Davies R. Randomised controlled trial to assess the safety and efficiency of a self-contained sampling device/disposable bronchoscope system versus usual sampling procedure (RASECAL). BMJ Open Respir Res. 2026 Aug 31;13(1):e004249. doi: 10.1136/bmjresp-2026-004249.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damon 0 Foster, 0 principal investigator
Chelsea and Westminster NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of two sampling pots (time frame: 1month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05964075, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.