VENTILATIONCAPNOSSPINCT03370081
Effects of Capnometry Monitoring in Post Anesthesia Care Unit
A study testing CAPNOGRAPHY in people with VENTILATION and Capnography, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
There is few information about the best capnometry value in recovery room for intubated awakening patients. Furthermore, capnometry values could influence ventilation applied by nurses on these patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- VENTILATION, Capnography
- What is being tested?
- CAPNOGRAPHY
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2018to 1 Jun 2018
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major patients with given written consent
- General anesthesia, induction with Propofol infusion and Target-Controlled Infusion (TCI) remifentanil, relayed with inhaled sevoflurane and TCI remifentanil
- Upper airway control with naso-orotracheal tube or laryngeal mask
- Ventilated normotherm patients in PACU
Who cannot join
- Minor or pregnant patients
- Obesity with Body Mass Index > 40 kg/m²
- Chronic respiratory disease with SpO2<90% in ambiant air
- Cyanogenic heart disease
- Patients under myorelaxant in PACU
Trial locations and contacts
1 site in 1 country.
About this study
There is few information about the best capnometry value in recovery room for intubated awakening patients. Furthermore, capnometry values could influence ventilation applied by nurses on these patients. The aim of this study is to observe the effects of capnometry monitoring on intubated awakening patients in recovery room.
Read the detailed description
In France, there is actually no recommandation about capnography monitoring in recovery rooms. Nevertheless, some patients are still ventilated in post-anesthesia care units during awakening period. Alveolar hypoventilation could induce moderate hypercapnia, thereby stimulate central ventilatory command. However, this hypoventilation could delay the clearance of anesthetic gases. Capnometry monitoring could influence ventilation applied to these patients. Recovery rooms nurses would perform moderate hyperventilation in response to hign capnometry values. This method could enhance gases elimination, with faster spontaneous breathing recovery and extubation. Length of stay in recovery room could also be shortened. An objective surrogate of ventilation is maximal End Tidal CO2, if there is no alveolo-capillary gradient abnormality (Obesity, Chronic respiratory disease, Cyanogenic heart disease). Thus, this study will compare the percentage of patients who reached a maximum End Tidal CO2 greater than 45mmHg during awakening period in post-anesthesia care unit (PACU) in 2 groups :
- first group ("non-blind group") with capnography monitoring see by the PACU nurses
- second group ("blind group") with capnography monitoring but PACU nurses cannot see the values Other parameters like the time between ventilator's disconnection and the first ventilatory cycle in spontaneous ventilation, the time between ventilator's disconnection and tracheal extubation or laryngeal mask's withdrawal, the minimal SpO2 reached after tracheal extubation or laryngeal mask withdrawal or the length of stay in PACU are also recorded.
- Conditions
- VENTILATION, Capnography
- Being tested
- CAPNOGRAPHY
- Keywords
- Capnometry, Capnography, ETCO2, Recovery room, Post-anesthesia care unit
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPNOGRAPHYDevice
MONITORING OF CAPNOMETRY USING ETCO2 METHOD
| Study group | Role | What they receive |
|---|---|---|
| CAPNO+ | Experimental | END TIDAL CO2(EtCO2) is monitoring and PACU nurses can see the values delivered by the capnography device Receives: Device: CAPNOGRAPHY |
| CAPNO- | No intervention | END TIDAL CO2(EtCO2) is monitoring but PACU nurses cannot see the values delivered by the capnography device |
What is being measured
The primary outcome is the main question the study is designed to answer.
End Tidal CO2 up
Percentage of patients who reached a maximum End Tidal CO2 greater than 45mmHg during awakening period in post-anesthesia care unit (PACU)
Measured: through awakening period in PACU, an average of 30 minutes
Secondary outcomes (8)
End Tidal CO2 max 1
Maximum EtCO2 reached before the first ventilatory cycle in spontaneaous ventilation
Measured: through awakening period in PACU, an average of 15 minutes
End Tidal CO2 max 2
Maximum EtCO2 reached after the first ventilatory cycle in spontaneous ventilation
Measured: through awakening period in PACU, an average of 30 minutes
respiratory rate
Respiratory rate applied by PACU nurse before the first ventilatory cycle in spontaneous ventilation
Measured: through awakening period in PACU, an average of 15 minutes
spontaneous ventilation time
Time (in minutes) between ventilator's disconnection and the first ventilatory cycle in spontaneous ventilation
Measured: through awakening period in PACU, an average of 15 minutes
time for removal of airway device
Time (in minutes) between ventilator's disconnection and tracheal extubation or laryngeal mask's withdrawal
Measured: through awakening period in PACU, an average of 30 minutes
Spo2 min
Minimal SpO2 after tracheal extubation or laryngeal mask withdrawal
Measured: through awakening period in PACU, an average of 2 hours
length of stay in PACU
Length of stay in PACU in minutes
Measured: through awakening period in PACU, an average of 2 hours
time for oxygenotherapy removal
Time (in minutes) between tracheal extubation or laryngeal mask withdrawal and oxygenotherapy weaning
Measured: through awakening period in PACU, an average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start15 Jan 2018
- Primary completion1 May 2018
- Study completion1 Jun 2018
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 VENTILATIONStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karine Nouette-Gaulain, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370081
- Sponsor's protocol ID
- CHUBX2017/18
- Acronym
- CAPNOSSPI
- Status last verified
- Oct 2018
- First submitted
- 4 Dec 2017
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Potvin J, Etchebarne I, Soubiron L, Biais M, Roullet S, Nouette-Gaulain K. Effects of capnometry monitoring during recovery in the post-anaesthesia care unit: a randomized controlled trial in adults (CAPNOSSPI). J Clin Monit Comput. 2022 Apr;36(2):379-385. doi: 10.1007/s10877-021-00661-9. Epub 2021 Feb 7.
PubMed 33550546
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Capnometry Monitoring in Post Anesthesia Care Unit
- ClinicalTrials.gov ID
- NCT03370081
- Acronym / sponsor ID
- CAPNOSSPI / CHUBX2017/18
- Conditions
- VENTILATION, Capnography
- Keywords
- Capnometry, Capnography, ETCO2, Recovery room, Post-anesthesia care unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 12 Dec 2017 (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.
There is few information about the best capnometry value in recovery room for intubated awakening patients. Furthermore, capnometry values could influence ventilation applied by nurses on these patients. The aim of this study is to observe the effects of capnometry monitoring on intubated awakening patients in recovery room.
Detailed description
In France, there is actually no recommandation about capnography monitoring in recovery rooms. Nevertheless, some patients are still ventilated in post-anesthesia care units during awakening period. Alveolar hypoventilation could induce moderate hypercapnia, thereby stimulate central ventilatory command. However, this hypoventilation could delay the clearance of anesthetic gases. Capnometry monitoring could influence ventilation applied to these patients. Recovery rooms nurses would perform moderate hyperventilation in response to hign capnometry values. This method could enhance gases elimination, with faster spontaneous breathing recovery and extubation. Length of stay in recovery room could also be shortened. An objective surrogate of ventilation is maximal End Tidal CO2, if there is no alveolo-capillary gradient abnormality (Obesity, Chronic respiratory disease, Cyanogenic heart disease). Thus, this study will compare the percentage of patients who reached a maximum End Tidal CO2 greater than 45mmHg during awakening period in post-anesthesia care unit (PACU) in 2 groups :
- first group ("non-blind group") with capnography monitoring see by the PACU nurses
- second group ("blind group") with capnography monitoring but PACU nurses cannot see the values Other parameters like the time between ventilator's disconnection and the first ventilatory cycle in spontaneous ventilation, the time between ventilator's disconnection and tracheal extubation or laryngeal mask's withdrawal, the minimal SpO2 reached after tracheal extubation or laryngeal mask withdrawal or the length of stay in PACU are also recorded.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAPNO+ | Experimental | Device: CAPNOGRAPHYEND TIDAL CO2(EtCO2) is monitoring and PACU nurses can see the values delivered by the capnography device |
| CAPNO- | No intervention | –END TIDAL CO2(EtCO2) is monitoring but PACU nurses cannot see the values delivered by the capnography device |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Major patients with given written consent
- General anesthesia, induction with Propofol infusion and Target-Controlled Infusion (TCI) remifentanil, relayed with inhaled sevoflurane and TCI remifentanil
- Upper airway control with naso-orotracheal tube or laryngeal mask
- Ventilated normotherm patients in PACU
Key exclusion criteria (5 listed)
- Minor or pregnant patients
- Obesity with Body Mass Index > 40 kg/m²
- Chronic respiratory disease with SpO2<90% in ambiant air
- Cyanogenic heart disease
- Patients under myorelaxant in PACU
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAPNOGRAPHYMONITORING OF CAPNOMETRY USING ETCO2 METHOD | Device | CAPNO+ |
Primary outcome
End Tidal CO2 up
Time frame: through awakening period in PACU, an average of 30 minutes
Percentage of patients who reached a maximum End Tidal CO2 greater than 45mmHg during awakening period in post-anesthesia care unit (PACU)
8 secondary outcomes
End Tidal CO2 max 1
Time frame: through awakening period in PACU, an average of 15 minutes
End Tidal CO2 max 2
Time frame: through awakening period in PACU, an average of 30 minutes
respiratory rate
Time frame: through awakening period in PACU, an average of 15 minutes
spontaneous ventilation time
Time frame: through awakening period in PACU, an average of 15 minutes
time for removal of airway device
Time frame: through awakening period in PACU, an average of 30 minutes
Spo2 min
Time frame: through awakening period in PACU, an average of 2 hours
length of stay in PACU
Time frame: through awakening period in PACU, an average of 2 hours
time for oxygenotherapy removal
Time frame: through awakening period in PACU, an average of 1 hour
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 16 Oct 2018.
- Derived from this study: PubMed 33550546Potvin J, Etchebarne I, Soubiron L, Biais M, Roullet S, Nouette-Gaulain K. Effects of capnometry monitoring during recovery in the post-anaesthesia care unit: a randomized controlled trial in adults (CAPNOSSPI). J Clin Monit Comput. 2022 Apr;36(2):379-385. doi: 10.1007/s10877-021-00661-9. Epub 2021 Feb 7.
- 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. 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?
A study testing CAPNOGRAPHY in people with VENTILATION and Capnography, run by University Hospital, Bordeaux 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 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 16 Oct 2018. 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?
End Tidal CO2 up (time frame: through awakening period in PACU, an average of 30 minutes). 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 NCT03370081, 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 16 Oct 2018.