Condition category
Respiratory
Date applied
28/12/2016
Date assigned
20/01/2017
Last edited
30/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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)

Trial website

Contact information

Type

Public

Primary contact

Mrs Veerle Van Mossevelde

ORCID ID

Contact details

Universitair Ziekenhuis Brussel
Laarbeeklaan 101
Brussels
1090
Belgium

Type

Scientific

Additional contact

Dr Nadia Najafi

ORCID ID

Contact details

Laarbeeklaan 101
Brussels
1090
Belgium

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PSA-GI 01

Study information

Scientific title

Prevalence and predictors of adverse respiratory events during deep sedation using native airway for paediatric gastrointestinal endoscopy in lateral position

Acronym

Study hypothesis

An accurate risk assessment prior to the paediatric gastrointestinal endoscopy would enable the anaesthesiologists to reduce the likelihood of respiratory complications.

Ethics approval

Commissie Medische Ethiek (O.G. 016) Reflectiegroep Biomedische Ethiek, 08/02/2017, ref: 2016/418

Study design

Single-centre retrospective cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

20/03/2016

Overall trial end date

20/04/2017

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

3000

Participant 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

Recruitment start date

20/04/2016

Recruitment end date

31/12/2016

Locations

Countries of recruitment

Belgium

Trial participating centre

Universitair Ziekenhuis Brussel
Laarbeeklaan 101
Brussel
1090
Belgium

Sponsor information

Organisation

Universitair Ziekenhuis Brussel

Sponsor details

Laarbeeklaan 101
Brussels
1090
Belgium

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Universitair Ziekenhuis Brussel

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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

Intention to publish date

31/12/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

30/08/2017: Ethics approval has been added.