PErioperAtive CHildhood ObesitY

NCT03994419 | Unknown

• 1 other identifier: IRAS 248493
• Study Type: observational
• Target: 8,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pediatric Obesity; Obesity, Childhood; Overweight and Obesity; Perioperative/Postoperative Complications

Keywords

Paediatric; Anaesthesia

Outcome Measures

Primary Outcomes (1)

• Proportion of overweight and obesity in UK children attending for surgery

  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 Outcomes (4)

• Adverse events

  One week study period

• Paracetamol dosing variation

  One week study period

• Surgery types

  One week study period

• Comparison with the UK National Child Measurement Programme

  One week study period

Interventions

Anaesthesia for surgery PROCEDURE

Observational study observing proportion of obese and overweight children attending for surgery. Observing adverse events following general anaesthesia for surgery in obese versus healthy weight children.

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• Association of Paediatric Anaesthetists of Great Britain & Ireland (APAGBI): collaborator
• University of Aberdeen: collaborator
• Paediatric Anaesthesia Trainee Research Network (PATRN): collaborator

Related Publications (1)

• Burton ZA, Lewis R, Bennett T, McLernon DJ; Paediatric Anaesthesia Trainee Research Network; Engelhardt T, Brooks PB, Edwards MR. Prevalence of PErioperAtive CHildhood obesitY in children undergoing general anaesthesia in the UK: a prospective, multicentre, observational cohort study. Br J Anaesth. 2021 Dec;127(6):953-961. doi: 10.1016/j.bja.2021.07.034. Epub 2021 Oct 6.

  PMID: 34627621 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Overweight; Obesity; Postoperative Complications

Interventions

Anesthesia; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• Mark Edwards

  University Hospital Southampton NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zoe A Burton, MBBCh

CONTACT

00447921865041; UHS.PEACHY@nhs.net

Rachael Meering

CONTACT

00442381205044; Rachael.meering@uhs.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 21, 2019
• Study Start: September 9, 2019
• Primary Completion: October 6, 2019
• Study Completion: October 6, 2019
• Last Updated: June 21, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share