A Dedicated Sedation Team for Paediatric Procedural Sedation

February 17, 2021 updated by: Universitätsklinikum Hamburg-Eppendorf

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
784

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children from 1 day to 20 years

Description

Inclusion Criteria:

  • Children (age 0-20 years) receiving procedural sedation
  • Procedural sedation performed by the Children's Analgosedation Team

Exclusion Criteria:

  • Missing medical records
  • Procedural sedation not performed by the Children's Analgosedation Team

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From the beginning of sedation (administration of 1. sedation drug) until the end of sedation (patient regained consciousness), assessed up to 6 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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)
Patient age in month
At the beginning of sedation (administration of 1. sedation drug)
Sex
Time Frame: At the beginning of sedation (administration of 1. sedation drug)
Male or female
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)
ASA physical status I / II / III / IV
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)
Date as YEAR/MONTH/DAY
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)
Diagnosis that prompted the need for the procedure, categorized according to the subspecialty (hematology/oncology, nephrology, hepatology, gastroenterology, metabolic medicine, neurology, pulmonology, cardiology)
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
Propofol or Midazolam in mg kg-1
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
Esketamine in mg kg-1 or remifentanil in µg kg-1 min-1
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)
Signs of runny nose and/or cough
At the beginning of sedation (administration of 1. sedation drug)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitätsklinikum Hamburg-Eppendorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CAST-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sedation Complication

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings