Anesthesia ComplicationPulmojetNCT04209608
Observational Study on Respiratory Impact of High-frequency Jet Ventilation (JVHF) in Interventional Radiology (RI)
An observational study of Anesthesia Complication, run by Nantes University Hospital at 1 site in France.
Trial summary
Jet ventilation is used in interventional radiology to reduce respiratory movement and facilitate tumor destruction. The purpose of this study is to describe the respiratory impact of this technique Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia Complication
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 12 Mar 2020to 23 Nov 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will be offered to patients benefiting from thermoablation of abdominal tumors under JVHF. Recruitment will take place during the pre-anesthetic consultation.
Who may be able to join
- Major patient
- Patient benefiting from an abdominal tumor thermoablation procedures
- Patient who gave consent
- Patient with a social protection scheme
Who cannot join
- Pulmonary thermoablation procedures
- Thermoablation of abdominal tumors required a transpleural passage
- Patient under guardianship or curatorship
- Patient not understanding French
Trial locations and contacts
1 site in 1 country.
About this study
Jet ventilation is used in interventional radiology to reduce respiratory movement and facilitate tumor destruction. The purpose of this study is to describe the respiratory impact of this technique
Read the detailed description
Use imaging and respiratory data to describe the impact of JVHF during tumor thermoablation procedures
- Conditions
- Anesthesia Complication
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the respiratory impact after the use of JVHF after thermoablation of a solid abdominal tumour.
Respiratory complication rate.
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Describe the number of ventilatory disorders
Score Radiological Atelectasis Score (RAS) of Richter Larsen - RAS: 0, clear lung field; 1, plate like atelectasis or slight infiltration; 2, partial atelectasis; 3, lobar atelectasis; 4, bilateral lobar atelectasis.
Measured: through study completion, an average of 1 year
Describe the incidence of hypoxemia during JVHF
Difference between oxygen saturation at the end of the procedure and at the beginning of the procedure
Measured: through study completion, an average of 1 year
Describe the incidence of hypercapnia at the time of a JVHF
Difference between end of procedure and beginning of procedure capnia
Measured: through study completion, an average of 1 year
Describe the incidence of barotraumatic pulmonary lesions at the time of a JVHF
Presence of barotraumatic pulmonary lesions on the imaging
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start12 Mar 2020
- Primary completion23 Nov 2020
- Study completion23 Nov 2020
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 Anesthesia ComplicationStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209608
- Sponsor's protocol ID
- RC19_0416
- Acronym
- Pulmojet
- Status last verified
- Sep 2021
- First submitted
- 20 Dec 2019
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Trochu T, Desfriches-Doria N, Grillot N, Feuillet F, Lair D, Liberge R, Douane F, Dumont R, David A. Safety of High-Frequency Jet Ventilation During Image-Guided Thermal Ablation Procedures. Cardiovasc Intervent Radiol. 2023 Mar;46(3):360-368. doi: 10.1007/s00270-023-03358-5. Epub 2023 Jan 19.
PubMed 36658374
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Respiratory Impact of High-frequency Jet Ventilation (JVHF) in Interventional Radiology (RI)
- ClinicalTrials.gov ID
- NCT04209608
- Acronym / sponsor ID
- Pulmojet / RC19_0416
- Conditions
- Anesthesia Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- 23 Nov 2020 (actual)
- Study completion
- 23 Nov 2020 (actual)
- First posted
- 24 Dec 2019 (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.
Jet ventilation is used in interventional radiology to reduce respiratory movement and facilitate tumor destruction. The purpose of this study is to describe the respiratory impact of this technique
Detailed description
Use imaging and respiratory data to describe the impact of JVHF during tumor thermoablation procedures
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be offered to patients benefiting from thermoablation of abdominal tumors under JVHF. Recruitment will take place during the pre-anesthetic consultation.
Key inclusion criteria (4 listed)
- Major patient
- Patient benefiting from an abdominal tumor thermoablation procedures
- Patient who gave consent
- Patient with a social protection scheme
Key exclusion criteria (4 listed)
- Pulmonary thermoablation procedures
- Thermoablation of abdominal tumors required a transpleural passage
- Patient under guardianship or curatorship
- Patient not understanding French
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
evaluate the respiratory impact after the use of JVHF after thermoablation of a solid abdominal tumour.
Time frame: through study completion, an average of 1 year
Respiratory complication rate.
4 secondary outcomes
Describe the number of ventilatory disorders
Time frame: through study completion, an average of 1 year
Describe the incidence of hypoxemia during JVHF
Time frame: through study completion, an average of 1 year
Describe the incidence of hypercapnia at the time of a JVHF
Time frame: through study completion, an average of 1 year
Describe the incidence of barotraumatic pulmonary lesions at the time of a JVHF
Time frame: through study completion, an average of 1 year
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 13 Sep 2021.
- Derived from this study: PubMed 36658374Trochu T, Desfriches-Doria N, Grillot N, Feuillet F, Lair D, Liberge R, Douane F, Dumont R, David A. Safety of High-Frequency Jet Ventilation During Image-Guided Thermal Ablation Procedures. Cardiovasc Intervent Radiol. 2023 Mar;46(3):360-368. doi: 10.1007/s00270-023-03358-5. Epub 2023 Jan 19.
- Individual participant dataSharing planned: No
Related trials for Anesthesia Complication
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Anesthesia Complication, run by Nantes University Hospital at 1 site in France.
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 4 inclusion and 4 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 13 Sep 2021. 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 France. 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?
evaluate the respiratory impact after the use of JVHF after thermoablation of a solid abdominal tumour. (time frame: through study completion, an average of 1 year). 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 NCT04209608, 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 13 Sep 2021.