Mechanical VentilationDELTA-CAPNONCT04489615
Identification of Risk Factors for Alteration of the Cellular-arterial Gradient of CO2
An observational study of Mechanical Ventilation and Prehospital Capnography Monitoring, run by University Hospital, Angers at 1 site in France.
Trial summary
Monocentric, prospective, observational and descriptive study on the evaluation of risk factors for alteration of the alveoarterial gradient of CO2 in pre-hospital patients, intubated and then ventilated in an invasive manner; and their impact on intra-arterial fatehospital. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Mechanical Ventilation, Prehospital Capnography Monitoring
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jun 2020to 1 Jun 2021
- How long will I take part?
- 1 Year
- 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: The patients included are the major patients, intubated and ventilated in pre-hospital, transferred by the medical team to the University Hospital of Angers. The ventilation settings are left to the caregiver's discretion, as is the purpose of Etco2.
Who may be able to join
- 18 years of age,
- Endotracheal intubation in pre-hospital and mechanical ventilation,
- Monitoring of Etco2 in pre-hospital settings
Who cannot join
- Identification of a chest wound blowing during pre-hospital care,
- No technical possibility for performing or analysing arterial sampling,
- Death during pre-hospital care,
- A person who has objected to the processing of his data for research at minimal risk and constraints (category 2) or for research on data, as well as persons subject to legal protection measures.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Quentin Carraro
Angers, 49100
Quentin Carraro, 778817861 ext. +33, quentin.carrar@gmail.com
About this study
Official title: DELTA-CAPNO: Identification of Risk Factors for Alteration of the Cellular-arterial Gradient of CO2 in Pre-hospital Patients
Monocentric, prospective, observational and descriptive study on the evaluation of risk factors for alteration of the alveoarterial gradient of CO2 in pre-hospital patients, intubated and then ventilated in an invasive manner; and their impact on intra-arterial fatehospital.
- Keywords
- capnography prehospital
What is being measured
The primary outcome is the main question the study is designed to answer.
identification of risks factors for alteration of the cellular arterial gradient of CO2 in Pre hospital patients
The main objective is therefore to determine the main risk factors to observe an alteration of the alveoarterial gradient in CO2, at the hospital care (fixed at 10 mmHg).
Measured: from january 2020 to april 2021
Secondary outcomes (7)
Intrahospital mortality
prognostic evidence of altered alveocapillary gradient on intrahospital mortality
Measured: from january 2020 to april 2021
Time of hospital admission
the prognosis of the finding of an altered alveocapillary gradient on the time of hospital admission
Measured: from january 2020 to april 2021
length of mecanical ventilation
the prognosis of the finding of an altered alveocapillary gradient on the duration of ventilation
Measured: from january 2020 to april 2021
Occurence of pneumonia
the prognosis of the finding of an altered alveocapillary gradient on the occurrence of pneumonia
Measured: from january 2020 to april 2021
Acute respiratory distress syndrom (ARDS)
the prognosis of the finding of an altered alveocapillary gradient on the occurrence of ARDS
Measured: from january 2020 to april 2021
Length of stay
the prognosis of the finding of an altered alveocapillary gradient on the length of stay
Measured: from january 2020 to april 2021
Intrahospital mortality (subpopulation of traumatized patients which had suffered from intracranial hypertension
prognostic evidence of altered alveocapillary gradient, onset of an episode of intracranial hypertension, and intrahospital survival of severely traumatized patients (GCS < 9).
Measured: from january 2020 to april 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start3 Jun 2020
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Quentin qc Carraro, md, Principal investigator, UH Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489615
- Sponsor's protocol ID
- UH Angers
- Acronym
- DELTA-CAPNO
- Status last verified
- Nov 2020
- First submitted
- 23 Jul 2020
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DELTA-CAPNO: Identification of Risk Factors for Alteration of the Cellular-arterial Gradient of CO2 in Pre-hospital Patients
- ClinicalTrials.gov ID
- NCT04489615
- Acronym / sponsor ID
- DELTA-CAPNO / UH Angers
- Keywords
- capnography prehospital
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 28 Jul 2020 (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.
Monocentric, prospective, observational and descriptive study on the evaluation of risk factors for alteration of the alveoarterial gradient of CO2 in pre-hospital patients, intubated and then ventilated in an invasive manner; and their impact on intra-arterial fatehospital.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients included are the major patients, intubated and ventilated in pre-hospital, transferred by the medical team to the University Hospital of Angers. The ventilation settings are left to the caregiver's discretion, as is the purpose of Etco2.
Key inclusion criteria (3 listed)
- 18 years of age,
- Endotracheal intubation in pre-hospital and mechanical ventilation,
- Monitoring of Etco2 in pre-hospital settings
Key exclusion criteria (4 listed)
- Identification of a chest wound blowing during pre-hospital care,
- No technical possibility for performing or analysing arterial sampling,
- Death during pre-hospital care,
- A person who has objected to the processing of his data for research at minimal risk and constraints (category 2) or for research on data, as well as persons subject to legal protection measures.
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
identification of risks factors for alteration of the cellular arterial gradient of CO2 in Pre hospital patients
Time frame: from january 2020 to april 2021
The main objective is therefore to determine the main risk factors to observe an alteration of the alveoarterial gradient in CO2, at the hospital care (fixed at 10 mmHg).
7 secondary outcomes
Intrahospital mortality
Time frame: from january 2020 to april 2021
Time of hospital admission
Time frame: from january 2020 to april 2021
length of mecanical ventilation
Time frame: from january 2020 to april 2021
Occurence of pneumonia
Time frame: from january 2020 to april 2021
Acute respiratory distress syndrom (ARDS)
Time frame: from january 2020 to april 2021
Length of stay
Time frame: from january 2020 to april 2021
Intrahospital mortality (subpopulation of traumatized patients which had suffered from intracranial hypertension
Time frame: from january 2020 to april 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Quentin qc Carraro, md principal investigator
UH Angers
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 Mechanical Ventilation and Prehospital Capnography Monitoring, run by University Hospital, Angers 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 3 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: status not confirmed, as of the sponsor's last update on 2 Dec 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Quentin qc Carraro, md (778817861 ext. +33, quentin.carrar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
identification of risks factors for alteration of the cellular arterial gradient of CO2 in Pre hospital patients (time frame: from january 2020 to april 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2020.