Acute Intentional OverdoseCAPNOTOXNCT01800123
EtCO2 Monitoring in Acute Self-poisoning
An observational study of Acute Intentional Overdose, run by University Hospital, Grenoble at 1 site in France.
Trial summary
There is no consensus on monitoring criteria in acute self poisoning. Clinical scores, vital signs or lactatemia have failed to prove good predictive value. The main acute self poisoning complication is decreased consciousness level with consequent increased risk of hypoxemia and aspiration pneumonitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Intentional Overdose
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2012to Nov 2013
- 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: All patients over 18y/o admitted in the ED for acute self poisoning.
Who may be able to join
- >18y/o
- acute self poisoning patients
- patients requiring monitoring according to physician's opinion
- patients not requiring invasive ventilation at ED admission
Who cannot join
- Pregnant woman
- patients deprived of liberty
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Genoble university hospital
Grenoble
Maxime Maignan, MD, 33 4 76 76 59 34, mmaignan@chu-grenoble.fr
Maxime Maignan, MD, MSc
About this study
Official title: Continuous EtCO2 Monitoring in Acute Self Poisoned Patients Admitted in an Emergency Department
There is no consensus on monitoring criteria in acute self poisoning. Clinical scores, vital signs or lactatemia have failed to prove good predictive value.
The main acute self poisoning complication is decreased consciousness level with consequent increased risk of hypoxemia and aspiration pneumonitis.
Several clinical studies have recently shown that EtCO2 monitoring can be valuable in procedural sedation in the emergency department. It is able to predict hypoxemia before any SaO2 decrease and any complications related to these procedures.
We therefore hypothesized that EtCO2 could help in acute self poisoning patients' monitoring in the ED.
- Conditions
- Acute Intentional Overdose
- Keywords
- Intoxication, overdose, poisoning, EtCO2, emergency medicine
- Medical subject headings
- Drug Overdose, Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute poisoning | Consecutive acute drug self poisoned patients admitted in the ED. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ROC curve of maximal EtCO2 to predict poisoning complication
Poisoning complications are defined as:
Hypoxia (Spo2<93%) and/or Respiratory rate <10/min or >25/min and/or ICU admission and/or Oro tracheal intubation
Measured: During the first 2 hours of ED admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startMar 2012
- Primary completionNov 2013 (estimated)
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 Acute Intentional OverdoseStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800123
- Sponsor's protocol ID
- 2011-14
- Acronym
- CAPNOTOX
- Status last verified
- Feb 2013
- First submitted
- 25 Feb 2013
- Last updated
- 27 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Viglino D, Bourez D, Collomb-Muret R, Schwebel C, Tazarourte K, Dumanoir P, Paquier C, Danel V, Debaty G, Maignan M. Noninvasive End Tidal CO2 Is Unhelpful in the Prediction of Complications in Deliberate Drug Poisoning. Ann Emerg Med. 2016 Jul;68(1):62-70.e1. doi: 10.1016/j.annemergmed.2015.11.037. Epub 2016 Jan 23.
PubMed 26810758
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous EtCO2 Monitoring in Acute Self Poisoned Patients Admitted in an Emergency Department
- ClinicalTrials.gov ID
- NCT01800123
- Acronym / sponsor ID
- CAPNOTOX / 2011-14
- Conditions
- Acute Intentional Overdose
- Keywords
- Intoxication, overdose, poisoning, EtCO2, emergency medicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Nov 2013 (estimated)
- First posted
- 27 Feb 2013 (estimated)
- 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.
There is no consensus on monitoring criteria in acute self poisoning. Clinical scores, vital signs or lactatemia have failed to prove good predictive value.
The main acute self poisoning complication is decreased consciousness level with consequent increased risk of hypoxemia and aspiration pneumonitis.
Several clinical studies have recently shown that EtCO2 monitoring can be valuable in procedural sedation in the emergency department. It is able to predict hypoxemia before any SaO2 decrease and any complications related to these procedures.
We therefore hypothesized that EtCO2 could help in acute self poisoning patients' monitoring in the ED.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute poisoning | – | –Consecutive acute drug self poisoned patients admitted in the ED. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients over 18y/o admitted in the ED for acute self poisoning.
Key inclusion criteria (4 listed)
- >18y/o
- acute self poisoning patients
- patients requiring monitoring according to physician's opinion
- patients not requiring invasive ventilation at ED admission
Key exclusion criteria (2 listed)
- Pregnant woman
- patients deprived of liberty
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
ROC curve of maximal EtCO2 to predict poisoning complication
Time frame: During the first 2 hours of ED admission
Poisoning complications are defined as: Hypoxia (Spo2<93%) and/or Respiratory rate <10/min or >25/min and/or ICU admission and/or Oro tracheal intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2013.
- Derived from this study: PubMed 26810758Viglino D, Bourez D, Collomb-Muret R, Schwebel C, Tazarourte K, Dumanoir P, Paquier C, Danel V, Debaty G, Maignan M. Noninvasive End Tidal CO2 Is Unhelpful in the Prediction of Complications in Deliberate Drug Poisoning. Ann Emerg Med. 2016 Jul;68(1):62-70.e1. doi: 10.1016/j.annemergmed.2015.11.037. Epub 2016 Jan 23.
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.
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 Intentional Overdose, run by University Hospital, Grenoble 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 2 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 27 Feb 2013. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ROC curve of maximal EtCO2 to predict poisoning complication (time frame: During the first 2 hours of ED admission). 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 NCT01800123, 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 27 Feb 2013.