Obesity: Alterations in lung mechanics - impact on the incidence of perioperative respiratory adverse events (OPRAE)

Not Applicable

Completed

• Conditions: The impact of obesity on the incidence of perioperative respiratory adverse events and the alterations in lung mechanics compared to normal weight children.; Anaesthesiology - Anaesthetics; Respiratory - Normal development and function of the respiratory system; Diet and Nutrition - Obesity

• Registration Number: ACTRN12614000424606
• Lead Sponsor: Britta Regli Von Ungern Sternberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

*Children undergoing elective surgery
*Male or Female aged between 6 and 16 years
*Children with a BMI more than the 5th and less than the 85th percentile (normal weight group)
*Children with a BMI more than or equal to 85th percentile (overweight and obese group)
*Children having a laryngeal mask airway (LMA).

Exclusion Criteria

*Children with a known cardiopulmonary disease:
*Uncorrected congenital heart disease
*Primary/secondary pulmonary hypertension
*Cardiac/thoracic malformations/tumours
*Structural lung changes
*Airway malformations, thorax deformity
*Children unable to perform the lung function tests.
*Children receiving a sedating premedication (e.g. midazolam, clonidine) before surgery.
*Children having used a bronchodilator within 5 hours prior to surgery.
*Children having an endotracheal tube inserted during anaesthesia
The above list is not an exhaustive list. Other less common cardiopulmonary conditions will be assessed by the anaesthetist in charge in consulation with the study team.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is to assess the incidence of Perioperative Respiratory Adverse Events between children who are overweight/obese and children who have a normal weight.<br>These respiratory adverse events include laryngospasm, bronchospasm, desaturation <95%, airway obstruction, severe coughing and/or postoperative stridor as assessed by the treating anaesthetist and in recovery by the treating nurses.[The Respiratory adverse events will be recorded at anaesthesia induction, maintenance, emergence and in recovery. ]

Secondary Outcome Measures

Name	Time	Method
The secondary outcome is to compare the effects of postural changes in lung volumes and respiratory mechanics between children who are overweight/obese and children who have a normal weight.[These outcomes will be measured using the forced ocsilation technique prior to and after anaesthesia induction and by using the multiple breath washout technique prior to anaesthesia induction. ]