Acute Respiratory FailureTEMPONCT03826797
Correlation Between Trans Esophageal Pressure and Non-invasive Respiratory Support Failure in Patients With Acute Hypoxic Respiratory Failure
An observational study of Acute Respiratory Failure, run by University of Modena and Reggio Emilia at 1 site in Italy.
Trial summary
This study aims at assessing the correlation between trans esophageal pressure and related respiratory mechanics (including, among others, nasal pressure-Pnose) and non-invasive respiratory support failure in patients with acute hypoxic respiratory failure of different etiology (including COVID-19). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 16 Oct 2016to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: See inclusion criteria
Who may be able to join
- Age >18 years
- Acute hypoxic respiratory failure (P/F < 200)
Who cannot join
- Acute pulmonary edema
- Chest wall deformities
- Immediate need for Mechanical Ventilation
- Pregnancy
- Hypercapnic RF
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
University Hospital of Modena Policlinico
Modena, 41125
Alessandro Marchioni, MD, PhD, marchioni.alessandro@unimore.it
About this study
This study aims at assessing the correlation between trans esophageal pressure and related respiratory mechanics (including, among others, nasal pressure-Pnose) and non-invasive respiratory support failure in patients with acute hypoxic respiratory failure of different etiology (including COVID-19).
- Conditions
- Acute Respiratory Failure
- Keywords
- Non invasive ventilation, Esophageal pressure, Transpulmonary pressure
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophageal pressure impact on non invasive respiratory support (NRS) failure
Correlation between esophageal pressure values within 24 hours from NRS start and NRS failure
Measured: 24 hours
Secondary outcomes (5)
Transpulmonary pressure impact on NRS failure
Correlation between transpulmonary pressure values within 24 hours from NRS start and NRS failure
Measured: 24 hours
Dynamic compliance impact on NRS failure
Correlation between dynamic compliance values within 24 hours from NRS start and NRS failure
Measured: 24 hours
Dynamic mechanical power impact on NRS failure
Correlation between dynamic mechanical power within 24 hours from NRS start and NRS failure
Measured: 24 hours
Correlation between nasal pressure (Pnose) and esophageal pressure
Correlation between nasal pressure (Pnose) and esophageal pressure
Measured: 24 hours
Pnose impact on NRS failure
Correlation between Pnose within 24 hours from NRS start and NRS failure
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start16 Oct 2016
- Primary completion28 Feb 2024 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Marchioni, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826797
- Sponsor's protocol ID
- UModenaReggio 266/16
- Other IDs
- 266/16
- Acronym
- TEMPO
- Status last verified
- Mar 2023
- First submitted
- 28 Jan 2019
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tonelli R, Fantini R, Bruzzi G, Tabbi L, Cortegiani A, Crimi C, Pisani L, Moretti A, Guidotti F, Rizzato S, Puggioni D, Vermi M, Tacconi M, Bellesia G, Ragnoli B, Castaniere I, Marchioni A, Clini E. Effect of high flow nasal oxygen on inspiratory effort of patients with acute hypoxic respiratory failure and do not intubate orders. Intern Emerg Med. 2024 Mar;19(2):333-342. doi: 10.1007/s11739-023-03471-w. Epub 2023 Dec 29.
PubMed 38158462Tonelli R, Cortegiani A, Marchioni A, Fantini R, Tabbi L, Castaniere I, Biagioni E, Busani S, Nani C, Cerbone C, Vermi M, Gozzi F, Bruzzi G, Manicardi L, Pellegrino MR, Beghe B, Girardis M, Pelosi P, Gregoretti C, Ball L, Clini E. Nasal pressure swings as the measure of inspiratory effort in spontaneously breathing patients with de novo acute respiratory failure. Crit Care. 2022 Mar 24;26(1):70. doi: 10.1186/s13054-022-03938-w.
PubMed 35331323Tonelli R, Fantini R, Tabbi L, Castaniere I, Pisani L, Pellegrino MR, Della Casa G, D'Amico R, Girardis M, Nava S, Clini EM, Marchioni A. Early Inspiratory Effort Assessment by Esophageal Manometry Predicts Noninvasive Ventilation Outcome in De Novo Respiratory Failure. A Pilot Study. Am J Respir Crit Care Med. 2020 Aug 15;202(4):558-567. doi: 10.1164/rccm.201912-2512OC.
PubMed 32325004
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Trans Esophageal Pressure and Non-invasive Respiratory Support Failure in Patients With Acute Hypoxic Respiratory Failure
- ClinicalTrials.gov ID
- NCT03826797
- Acronym / sponsor ID
- TEMPO / UModenaReggio 266/16
- Conditions
- Acute Respiratory Failure
- Keywords
- Non invasive ventilation, Esophageal pressure, Transpulmonary pressure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Modena and Reggio EmiliaUniversity, hospital or other
- Study start
- 16 Oct 2016 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Feb 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.
This study aims at assessing the correlation between trans esophageal pressure and related respiratory mechanics (including, among others, nasal pressure-Pnose) and non-invasive respiratory support failure in patients with acute hypoxic respiratory failure of different etiology (including COVID-19).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- See inclusion criteria
Key inclusion criteria (2 listed)
- Age >18 years
- Acute hypoxic respiratory failure (P/F < 200)
Key exclusion criteria (5 listed)
- Acute pulmonary edema
- Chest wall deformities
- Immediate need for Mechanical Ventilation
- Pregnancy
- Hypercapnic RF
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
Esophageal pressure impact on non invasive respiratory support (NRS) failure
Time frame: 24 hours
Correlation between esophageal pressure values within 24 hours from NRS start and NRS failure
5 secondary outcomes
Transpulmonary pressure impact on NRS failure
Time frame: 24 hours
Dynamic compliance impact on NRS failure
Time frame: 24 hours
Dynamic mechanical power impact on NRS failure
Time frame: 24 hours
Correlation between nasal pressure (Pnose) and esophageal pressure
Time frame: 24 hours
Pnose impact on NRS failure
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Derived from this study: PubMed 38158462Tonelli R, Fantini R, Bruzzi G, Tabbi L, Cortegiani A, Crimi C, Pisani L, Moretti A, Guidotti F, Rizzato S, Puggioni D, Vermi M, Tacconi M, Bellesia G, Ragnoli B, Castaniere I, Marchioni A, Clini E. Effect of high flow nasal oxygen on inspiratory effort of patients with acute hypoxic respiratory failure and do not intubate orders. Intern Emerg Med. 2024 Mar;19(2):333-342. doi: 10.1007/s11739-023-03471-w. Epub 2023 Dec 29.
- Derived from this study: PubMed 35331323Tonelli R, Cortegiani A, Marchioni A, Fantini R, Tabbi L, Castaniere I, Biagioni E, Busani S, Nani C, Cerbone C, Vermi M, Gozzi F, Bruzzi G, Manicardi L, Pellegrino MR, Beghe B, Girardis M, Pelosi P, Gregoretti C, Ball L, Clini E. Nasal pressure swings as the measure of inspiratory effort in spontaneously breathing patients with de novo acute respiratory failure. Crit Care. 2022 Mar 24;26(1):70. doi: 10.1186/s13054-022-03938-w.
- Derived from this study: PubMed 32325004Tonelli R, Fantini R, Tabbi L, Castaniere I, Pisani L, Pellegrino MR, Della Casa G, D'Amico R, Girardis M, Nava S, Clini EM, Marchioni A. Early Inspiratory Effort Assessment by Esophageal Manometry Predicts Noninvasive Ventilation Outcome in De Novo Respiratory Failure. A Pilot Study. Am J Respir Crit Care Med. 2020 Aug 15;202(4):558-567. doi: 10.1164/rccm.201912-2512OC.
- Individual participant dataSharing planned: Undecided
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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.
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 Acute Respiratory Failure, run by University of Modena and Reggio Emilia at 1 site in Italy.
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 2 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: looking for participants now, as of the sponsor's last update on 23 Mar 2023. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Marchioni, MD, PhD (00390594225859, marchioni.alessandro@unimore.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esophageal pressure impact on non invasive respiratory support (NRS) failure (time frame: 24 hours). 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 NCT03826797, which also lists 3 linked publications.
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 23 Mar 2023.