Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

PErioperAtive CHildhood ObesitY (PEACHY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03994419
Recruitment Status : Not yet recruiting
First Posted : June 21, 2019
Last Update Posted : June 21, 2019
Sponsor:
Collaborators:
Association of Paediatric Anaesthetists of Great Britain & Ireland (APAGBI)
University of Aberdeen
Paediatric Anaesthesia Trainee Research Network (PATRN)
Information provided by (Responsible Party):
University Hospital Southampton NHS Foundation Trust

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.


Condition or disease Intervention/treatment
Pediatric Obesity Obesity, Childhood Overweight and Obesity Perioperative/Postoperative Complications Procedure: Anaesthesia for surgery

  Show Detailed Description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 8000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Estimated Study Start Date : September 9, 2019
Estimated Primary Completion Date : October 6, 2019
Estimated Study Completion Date : October 6, 2019

Intervention Details:
  • Procedure: Anaesthesia for surgery
    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.


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Paracetamol dosing variation [ Time Frame: One week study period ]
    The variation in paracetamol dosing in obese children in the UK perioperative setting.

  3. 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.

  4. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994419


Contacts
Layout table for location contacts
Contact: Zoe A Burton, MBBCh 00447921865041 UHS.PEACHY@nhs.net
Contact: Rachael Meering 00442381205044 Rachael.meering@uhs.nhs.uk

Sponsors and Collaborators
University Hospital Southampton NHS Foundation Trust
Association of Paediatric Anaesthetists of Great Britain & Ireland (APAGBI)
University of Aberdeen
Paediatric Anaesthesia Trainee Research Network (PATRN)
Investigators
Layout table for investigator information
Principal Investigator: Mark Edwards University Hospital Southampton NHS Trust

Layout table for additonal information
Responsible Party: University Hospital Southampton NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03994419     History of Changes
Other Study ID Numbers: IRAS 248493
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital Southampton NHS Foundation Trust:
Paediatric
Anaesthesia

Additional relevant MeSH terms:
Layout table for MeSH terms
Nutrition Disorders
Obesity
Pediatric Obesity
Overweight
Postoperative Complications
Overnutrition
Body Weight
Signs and Symptoms
Pathologic Processes
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs