PErioperAtive CHildhood ObesitY (PEACHY)

June 20, 2019 updated by: University Hospital Southampton NHS Foundation Trust

PErioperAtive CHildhood obesitY (PEACHY): A Prospective Observational Cohort Study Investigating the Proportion of Overweight and Obese Children Presenting for a Procedure Under General Anaesthesia in the UK and the Incidence of Perioperative Adverse Outcomes in This Patient Group

The incidence of childhood obesity is at epidemic levels and increasing in the UK. Obese adults are considered a high-risk group of patients for general anaesthesia with published national guidelines on the best practice management. The proportion of children presenting for a procedure under general anaesthesia in the UK who are overweight or obese is currently unknown.

Obese children are perceived to be at greater risk of complications from general anaesthesia. Previous non-UK studies suggest they take longer to recover from anaesthesia, require more medications to combat nausea and vomiting and are at greater risk of complications that may threaten their airway and breathing.

This study involves reviewing the anaesthetic care record and patient notes to collect information relating to general anaesthesia and basic demographic data in children aged 2-16 years presenting for a procedure under general anaesthesia.

The aims of this study are to establish the prevalence of obesity in the paediatric surgical population (i.e. the proportion of children attending UK hospitals for procedures under general anaesthesia who are overweight or obese) and to ascertain whether obese children are at increased risk compared to their healthy weight counterparts.

This information will be used with the goal of reducing avoidable harm both at national and local level in the future.

Study Overview

Status

Status

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

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

IRAS 248493 REC 18/WM/0394 NIHR CPMS ID 40368

Hypotheses

  1. Overweight and obese children commonly present for procedures under general anaesthesia.
  2. Obese children are at higher risk of perioperative adverse events compared to their healthy-weight counterparts.
  3. There is wide variation in paracetamol drug dosing amongst obese children.
  4. Obese children may be more likely to present for certain surgery compared to their healthy-weight counterparts.

This observational cohort study will take place in NHS hospitals in the UK with trainee anaesthetists affiliated to the Paediatric Anaesthesia Trainee Research Network (PATRN). To increase coverage of sites in the UK, the project will be advertised through other trainee research networks including Research and Audit Federation of Trainees (RAFT) and through the Association of Paediatric Anaesthetists of Great Britain and Ireland (APAGBI) linkmen.

Each hospital taking part will have a nominated anaesthetic consultant and trainees who will act as local investigators collecting data. Data will be collected for all children aged 2-16 years weighing >12kg presenting for a procedure involving general anaesthesia during the defined study period. This will be one week (7 consecutive days). Using previous PATRN audit projects as a guide, we aim to enrol approximately 90 local sites which will give an estimated total of 7590 children attending for a procedure under general anaesthesia during the study period.

Patients will be identified by local trainee investigators (independent of delivery of anaesthesia but part of the anaesthetic department of the hospital) from operating department lists on the days of the study. Data will be collected on all eligible patients who undergo a procedure under general anaesthesia during the study period. Similar data collection tools have been used in previous PATRN audit projects.

Data will be collected from the paper or electronic anaesthetic record and clinical notes. Only routine clinical data will be included and where this is unavailable the domain will be left blank. Data will be collected using a single paper case report form (CRF) per patient. This will be initiated by the anaesthetist in the operating theatre and completed by recovery staff in PACU. Patient identifiable data in the form of hospital number and date of birth will be collected on the CRF for traceability in terms of missing data.

To calculate BMI, age (to the nearest month), gender, height and weight are required for each patient. It is anticipated that all hospitals would routinely measure weight but some hospitals may not routinely measure height prior to a procedure under general anaesthesia. NICE guidelines currently recommend that clinical judgement should be used to decide when to measure a person's height and weight, including at routine health checks. The preoperative setting is a specific health check prior to undergoing general anaesthesia and therefore an appropriate time to measure a child's height and weight.

Height will be measured with shoes removed to the nearest 0.1cm using a height measure with the child's head positioned so that the Frankfurt plane is horizontal. Body weight will be measured with patients lightly clad, to the nearest 0.1kg using a calibrated electronic weighing scale. If the local site is unable to collect age, gender, height and weight we will ask for the case to be logged and uploaded but for no other data to be collected. It is important to know how many cases we are unable to include in the analysis due to incomplete data.

Other information that would routinely be recorded within the clinical notes relating to the patients physical status, surgery, anaesthetic and specific perioperative adverse events will also be collected on the CRF.

The completed CRF will be taken directly to a secure location accessible by the local investigator. The data will be entered electronically via a secure encrypted connection into an online portal managed by Aberdeen University. The software used for data capture will be REDCap (Research Electronic Data Capture - http://www.project-redcap.org). REDCap is a mature, secure web application for building and managing online surveys and databases.

Each dataset entered will generate a unique identifier (ie the data will be pseudonymised); local investigators will be asked to keep a log of their unique identifiers linked to local hospital identification numbers. The hospital number will remain within the respective trusts, meaning only the local NHS staff responsible for care have access to personal identifying information. The study database will be closed for data entry a number of weeks after the study completion date. The anonymised responses from participating hospitals across the country will be analysed by a team of researchers.

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 (Anticipated)

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.
8000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

2 years to 16 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All children aged 2-16 years and weighing >12kg presenting for a procedure under general anaesthesia in registered sites across the UK (England, Wales, Scotland and Northern Ireland) during the study period.

Description

Inclusion Criteria:

  • All children aged greater than or equal to two years and less than 16 years presenting for a procedure under general anaesthesia.
  • Elective cases, day case and emergency cases will all be included.
  • Private cases being undertaken in NHS hospitals will be included.
  • MRI, radiology, oncology and dental cases will be included provided the patient receives a general anaesthetic.

Exclusion Criteria:

  • Procedures performed under sedation or local anaesthesia.
  • Children aged less than two years since the 0-24 month age group has separate growth charts, which are not currently recommended for interpretation of BMI.
  • Children weighing less than 12kg as these are not included on the growth charts for interpretation of BMI.
  • Children requiring general anaesthesia purely as part of intensive care treatment.
  • Children who are already anaesthetised in the intensive care setting being transferred for a scan or procedure without any intervention to their airway planned.
  • Children 16 years or more may be counted as children in some hospitals but not for the purposes of this study.

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

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
Proportion of overweight and obesity in UK children attending for surgery
Time Frame: One week study period
The proportion of overweight and obesity in UK children aged 2-16 years attending hospitals for a procedure under general anaesthesia.
One week study period

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
Adverse events
Time Frame: One week study period
The proportion of defined adverse events occurring in obese children as compared to healthy weight children attending for a procedure under general anaesthesia.
One week study period
Paracetamol dosing variation
Time Frame: One week study period
The variation in paracetamol dosing in obese children in the UK perioperative setting.
One week study period
Surgery types
Time Frame: One week study period
The proportion of obese children presenting for certain types of surgery compared to their healthy weight counterparts.
One week study period
Comparison with the UK National Child Measurement Programme
Time Frame: One week study period
The difference in the proportion of overweight and obesity in the perioperative setting compared to that from the UK National Child Measurement Programme (NCMP).
One week study period

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.
University Hospital Southampton NHS Foundation Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Aberdeen
Association of Paediatric Anaesthetists of Great Britain & Ireland (APAGBI)
Paediatric Anaesthesia Trainee Research Network (PATRN)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark Edwards, University Hospital Southampton NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ANTICIPATED)

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 9, 2019

Primary Completion (ANTICIPATED)

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.
October 6, 2019

Study Completion (ANTICIPATED)

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.
October 6, 2019

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).
June 20, 2019

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.
June 20, 2019

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.
June 21, 2019

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.
June 21, 2019

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.
June 20, 2019

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.
June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • IRAS 248493

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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