Prevalence and predictors of complications during sedation for paediatric gastrointestinal endoscopy
| ISRCTN | ISRCTN70362666 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70362666 |
| Secondary identifying numbers | PSA-GI 01 |
- Submission date
- 28/12/2016
- Registration date
- 20/01/2017
- Last edited
- 27/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
A gastrointestinal endoscopy is a procedure which allows a doctor to see the inside of the digestive tract. It is performed using a thin flexible tube with a tiny video camera on the end (an endoscope), which is passed down the throat into the stomach. It is one of the most commonly performed procedures in children, which requires deep sedation (general anaesthesia). The use of general anaesthesia in children can, in some cases, lead to complications with breathing. The aim of this study is to find out whether there are any common characteristics in children that can be used to predict whether they are likely to have breathing complications after having a gastrointestinal endoscopy procedure.
Who can participate?
Children aged 16 years and under who had a gastrointestinal endoscopy between January 2010 and August 2016.
What does the study involve?
Medical records of all children aged 16 years and under who had a gastrointestinal endoscopy as part of their usual care between January 2010 and August 2016 are retrieved from the hospital's medical registry. The medical records are then reviewed in order to find out background information about the children, information about what the procedure found and whether anything went wrong, information about the sedation used and whether there were any breathing complications after the procedure. This information is then used to find out whether children who had breathing complications have anything in common that can be used to flag up these cases in the future.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved to those participating.
Where is the study run from?
Universitair Ziekenhuis Brussel (Belgium)
When is the study starting and how long is it expected to run for?
March 2016 to April 2017
Who is funding the study?
Universitair Ziekenhuis Brussel (Belgium)
Who is the main contact?
1. Mrs Veerle Van Mossevelde (public)
2. Dr Nadia Najafi (scientific)
Contact information
Public
Universitair Ziekenhuis Brussel
Laarbeeklaan 101
Brussels
1090
Belgium
Scientific
Laarbeeklaan 101
Brussels
1090
Belgium
Study information
| Study design | Single-centre retrospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Prevalence and predictors of adverse respiratory events during deep sedation using native airway for paediatric gastrointestinal endoscopy in lateral position |
| Study objectives | An accurate risk assessment prior to the paediatric gastrointestinal endoscopy would enable the anaesthesiologists to reduce the likelihood of respiratory complications. |
| Ethics approval(s) | Commissie Medische Ethiek (O.G. 016) Reflectiegroep Biomedische Ethiek, 08/02/2017, ref: 2016/418 |
| Health condition(s) or problem(s) studied | Respiratory complications |
| Intervention | Medical records of all children up to the age of 16 years who required in- or outpatient procedural deep sedation and analgesia between January 1, 2010 and August 31, 2016 will be retrieved from the hospital's medical registry. The medical records of all these cases will be reviewed to identify those who underwent an elective or diagnostic gastrointestinal endoscopy. Demographic data, procedural data and anaesthetic data is then extrated. The type and timing of occurrence of adverse respiratory events will be reviewed from the initiation of the sedation procedure until 24 hours later. |
| Intervention type | Other |
| Primary outcome measure | Prevalence and predictors of respiratory complications during paediatric gastrointestinal endoscopy in lateral position is assessed through medical record review at the end of the study. |
| Secondary outcome measures | 1. Association between the type of sedative(s) used, dosage of induction agents administered and the adverse respiratory event experience is assessed through medical record review at the end of the study 2. Most appropriate induction dose of sedative(s) in normal- weight (mg per kg current body weight), obese and morbidly obese children (mg per kg current body weight and mg per kg ideal body weight) is assessed through medical record review at the end of the study 3. Ease of performing the procedure as satisfactory, difficult or impossible and the reason for this is assessed through medical record review at the end of the study 4. Failure rate and reason of this (e.g. inappropriate sedation or complications) is assessed through medical record review at the end of the study 5. Prevalence of post procedural nausea, vomiting and agitation is assessed through medical record review at the end of the study 6. Sedation time (time required to complete procedures), time to recovery and time to discharge is assessed through medical record review at the end of the study 7. Prevalence of any unplanned escalation of care e.g. transfer from the ward to the paediatric intensive care unit or prolonged hospitalization is assessed through medical record review at the end of the study |
| Overall study start date | 20/03/2016 |
| Completion date | 20/04/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 16 Years |
| Sex | Both |
| Target number of participants | 3000 |
| Total final enrolment | 3435 |
| Key inclusion criteria | 1. Children up to the age of 16 years 2. Required in- or outpatient procedural deep sedation and analgesia for an elective or diagnostic gastrointestinal endoscopy between January 1, 2010 and August 31, 2016 |
| Key exclusion criteria | 1. Children presenting with an American Society of Anaesthesiologists physical status classification ≥ IV 2. Ventilated children 3. Children already receiving sedative medications prior to sedation procedure 4. Children requiring therapeutic or urgent gastrointestinal endoscopy |
| Date of first enrolment | 20/04/2016 |
| Date of final enrolment | 31/12/2016 |
Locations
Countries of recruitment
- Belgium
Study participating centre
Brussel
1090
Belgium
Sponsor information
Hospital/treatment centre
Laarbeeklaan 101
Brussels
1090
Belgium
"ROR" |
https://ror.org/038f7y939 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results of this study may be incorporated in the subsequent studies and it is intended to be published in a high-impact peer reviewed journal.. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from nadia.najafi@uzbrussel.be |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2019 | 27/11/2020 | Yes | No |
Editorial Notes
27/11/2020: Publication reference and total final enrolment number added.
30/08/2017: Ethics approval has been added.
