AnesthesiaNCT04826146
Pediatric Validation of CONOX Monitor During Surgery
An observational study of Anesthesia and Anesthesia Awareness, run by Patricio Gonzalez Pizarro at 2 sites in Spain.
Trial summary
Pediatric Validation of CONOX Monitoring device (qCON and qNOX indices) for anesthesia depth during surgery Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Anesthesia Awareness, Nociceptive Pain
- What is being tested?
- Validation of qCON versus BIS
- Type of treatment
- Medical device
- How many people
- 65 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jul 2020to 30 Dec 2021
- 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 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children undergoing general anesthesia for a surgical procedure longer than 60 minutes
Who may be able to join
- General Anesthesia using propofol, sevoflurane or desflurane
- ASA I - IV
- Surgical procedure longer than 60 minutes
Who cannot join
- Neurological disorders
- Inability to correctly place BIS and CONOX probes in forehead
- Pregnancy
- Active prescription for drugs involving chronic pain and / or central nervous system
- Hemodynamic instability
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario de Santiago de Compostela (CHUS)
Santiago de Compostela
About this study
Official title: Monitoring the Depth of Anesthesia Using the qCON and qNOX Indices During Pediatric Surgery: a Multi-centre Study
Pediatric Validation of CONOX Monitoring device (qCON and qNOX indices) for anesthesia depth during surgery
- Conditions
- Anesthesia, Anesthesia Awareness, Nociceptive Pain, Pediatric ALL, Surgery, Pain
- Being tested
- Validation of qCON versus BIS
- Medical subject headings
- Intraoperative Awareness, Nociceptive Pain, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validation of qCON versus BISDevice
Also called Validation of qNOX Vs MOAA/S Scale
Correlation between qCON and BIS values (main outcome) and qNOX and MOAA/S scale are determined
| Study group | Role | What they receive |
|---|---|---|
| CONOX | Patients are monitored with BIS and CONOX Receives: Device: Validation of qCON versus BIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of qCOX and BIS values
Both values are correlated by a blind investigator
Measured: prospective data acquisition through study completion, an average of 1 year
Secondary outcomes (1)
Correlation of qNOX and MOAA/S values
Both values are correlated by a blind investigator
Measured: prospective data acquisition 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 posted1 Apr 2021
- Study start1 Jul 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Patricio Gonzalez Pizarro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Patricio Gonzalez Pizarro, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826146
- Sponsor's protocol ID
- PI-3871
- Status last verified
- Sep 2021
- First submitted
- 21 Mar 2021
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring the Depth of Anesthesia Using the qCON and qNOX Indices During Pediatric Surgery: a Multi-centre Study
- ClinicalTrials.gov ID
- NCT04826146
- Acronym / sponsor ID
- PI-3871
- Conditions
- Anesthesia, Anesthesia Awareness, Nociceptive Pain, Pediatric ALL, Surgery, Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Patricio Gonzalez PizarroUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 1 Apr 2021 (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.
Pediatric Validation of CONOX Monitoring device (qCON and qNOX indices) for anesthesia depth during surgery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CONOX | – | Device: Validation of qCON versus BISPatients are monitored with BIS and CONOX |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children undergoing general anesthesia for a surgical procedure longer than 60 minutes
Key inclusion criteria (3 listed)
- General Anesthesia using propofol, sevoflurane or desflurane
- ASA I - IV
- Surgical procedure longer than 60 minutes
Key exclusion criteria (5 listed)
- Neurological disorders
- Inability to correctly place BIS and CONOX probes in forehead
- Pregnancy
- Active prescription for drugs involving chronic pain and / or central nervous system
- Hemodynamic instability
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 |
|---|---|---|
| Validation of qCON versus BISAlso: Validation of qNOX Vs MOAA/S ScaleCorrelation between qCON and BIS values (main outcome) and qNOX and MOAA/S scale are determined | Device | CONOX |
Primary outcome
Correlation of qCOX and BIS values
Time frame: prospective data acquisition through study completion, an average of 1 year
Both values are correlated by a blind investigator
1 secondary outcome
Correlation of qNOX and MOAA/S values
Time frame: prospective data acquisition through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Anesthesia Awareness, run by Patricio Gonzalez Pizarro at 2 sites in Spain.
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 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: status not confirmed, as of the sponsor's last update on 9 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 2 sites in Spain. 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?
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?
Correlation of qCOX and BIS values (time frame: prospective data acquisition 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?
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 9 Sep 2021.