Sedation ComplicationNCT04760249
A Dedicated Sedation Team for Paediatric Procedural Sedation
An observational study of Sedation Complication, run by Universitätsklinikum Hamburg-Eppendorf.
Trial summary
At a tertiary care university hospital a specialized interdisciplinary team of paediatric anaesthesiologists and paediatric intensivists was established for providing analgosedation for diagnostic and therapeutic procedures. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sedation Complication
- How many people
- 784 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2015to 31 Dec 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children from 1 day to 20 years
Who may be able to join
- Children (age 0-20 years) receiving procedural sedation
- Procedural sedation performed by the Children's Analgosedation Team
Who cannot join
- Missing medical records
- Procedural sedation not performed by the Children's Analgosedation Team
About this study
Official title: The Impact of a Dedicated Sedation Team on the Incidence of Complications in Paediatric Procedural Analgosedation
At a tertiary care university hospital a specialized interdisciplinary team of paediatric anaesthesiologists and paediatric intensivists was established for providing analgosedation for diagnostic and therapeutic procedures. The aim of the present study was to analyse the incidence and risk factors of adverse events during procedural sedation performed by the Children's Analgosedation Team (CAST).
Read the detailed description
At a tertiary care university hospital a dedicated Children's Analgosedation Team (CAST) performs all procedural sedations in children outside the operating room. Often patient age, comorbidities and procedures involving the airway are considered risk factors for adverse events, but previous studies investigating adverse events did not involve implementation of a specialised sedation team. Medical records of all children receiving procedural sedation by the CAST were reviewed for the incidence of adverse events. A bivariate analysis as well as an analysis of variance using type II Wald chi-square tests were conducted for identifying potential risk factors for adverse Events.
- Conditions
- Sedation Complication
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Respiratory, hemodynamic, and other adverse events
Measured: From the beginning of sedation (administration of 1. sedation drug) until the end of sedation (patient regained consciousness), assessed up to 6 hours
Secondary outcomes (9)
Incidence of serious adverse events
Aspiration, vomiting/regurgitation, desaturation < 90% for > 30sec, hypotension < 50% of baseline, laryngospasm, thorax rigidity, unplanned admission to Paediatric Intensive Care Unit (PICU), cardiac arrest, and death
Measured: From the beginning of sedation (administration of 1. sedation drug) until the end of sedation (patient regained consciousness), assessed up to 6 hours
Age
Patient age in month
Measured: At the beginning of sedation (administration of 1. sedation drug)
Sex
Male or female
Measured: At the beginning of sedation (administration of 1. sedation drug)
American Society of Anesthesiology (ASA) status
ASA physical status I / II / III / IV
Measured: At the beginning of sedation (administration of 1. sedation drug)
Date of sedation
Date as YEAR/MONTH/DAY
Measured: At the beginning of sedation (administration of 1. sedation drug)
Category of the primary diagnosis
Diagnosis that prompted the need for the procedure, categorized according to the subspecialty (hematology/oncology, nephrology, hepatology, gastroenterology, metabolic medicine, neurology, pulmonology, cardiology)
Measured: At the beginning of sedation (administration of 1. sedation drug)
Type and dose of sedative
Propofol or Midazolam in mg kg-1
Measured: From the beginning of sedation (administration of 1. sedation drug) until the end of sedation (patient regained consciousness), assessed up to 6 hours
Type and dose of analgesic
Esketamine in mg kg-1 or remifentanil in µg kg-1 min-1
Measured: From the beginning of sedation (administration of 1. sedation drug) until the end of sedation (patient regained consciousness), assessed up to 6 hours
Upper respiratory tract infection (URI)
Signs of runny nose and/or cough
Measured: At the beginning of sedation (administration of 1. sedation drug)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Sep 2015
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation ComplicationStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- Retrospective
- Enrolment
- 784 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760249
- Sponsor's protocol ID
- CAST-01
- Status last verified
- Feb 2021
- First submitted
- 7 Feb 2021
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Dedicated Sedation Team on the Incidence of Complications in Paediatric Procedural Analgosedation
- ClinicalTrials.gov ID
- NCT04760249
- Acronym / sponsor ID
- CAST-01
- Conditions
- Sedation Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 784 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 18 Feb 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.
At a tertiary care university hospital a specialized interdisciplinary team of paediatric anaesthesiologists and paediatric intensivists was established for providing analgosedation for diagnostic and therapeutic procedures. The aim of the present study was to analyse the incidence and risk factors of adverse events during procedural sedation performed by the Children's Analgosedation Team (CAST).
Detailed description
At a tertiary care university hospital a dedicated Children's Analgosedation Team (CAST) performs all procedural sedations in children outside the operating room. Often patient age, comorbidities and procedures involving the airway are considered risk factors for adverse events, but previous studies investigating adverse events did not involve implementation of a specialised sedation team. Medical records of all children receiving procedural sedation by the CAST were reviewed for the incidence of adverse events. A bivariate analysis as well as an analysis of variance using type II Wald chi-square tests were conducted for identifying potential risk factors for adverse Events.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children from 1 day to 20 years
Key inclusion criteria (2 listed)
- Children (age 0-20 years) receiving procedural sedation
- Procedural sedation performed by the Children's Analgosedation Team
Key exclusion criteria (2 listed)
- Missing medical records
- Procedural sedation not performed by the Children's Analgosedation Team
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
Incidence of adverse events
Time frame: From the beginning of sedation (administration of 1. sedation drug) until the end of sedation (patient regained consciousness), assessed up to 6 hours
Respiratory, hemodynamic, and other adverse events
9 secondary outcomes
Incidence of serious adverse events
Time frame: From the beginning of sedation (administration of 1. sedation drug) until the end of sedation (patient regained consciousness), assessed up to 6 hours
Age
Time frame: At the beginning of sedation (administration of 1. sedation drug)
Sex
Time frame: At the beginning of sedation (administration of 1. sedation drug)
American Society of Anesthesiology (ASA) status
Time frame: At the beginning of sedation (administration of 1. sedation drug)
Date of sedation
Time frame: At the beginning of sedation (administration of 1. sedation drug)
Category of the primary diagnosis
Time frame: At the beginning of sedation (administration of 1. sedation drug)
Type and dose of sedative
Time frame: From the beginning of sedation (administration of 1. sedation drug) until the end of sedation (patient regained consciousness), assessed up to 6 hours
Type and dose of analgesic
Time frame: From the beginning of sedation (administration of 1. sedation drug) until the end of sedation (patient regained consciousness), assessed up to 6 hours
Upper respiratory tract infection (URI)
Time frame: At the beginning of sedation (administration of 1. sedation drug)
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 18 Feb 2021.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Sedation Complication, run by Universitätsklinikum Hamburg-Eppendorf.
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 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: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence of adverse events (time frame: From the beginning of sedation (administration of 1. sedation drug) until the end of sedation (patient regained consciousness), assessed up to 6 hours). 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 18 Feb 2021.