NCT02036021

Brief Summary

Mortality related with cardiac arrest in anesthetized children has diminished over several decades from 2.9 per 10000 anesthesias in 1961 to 0.21 per 10000 anesthesias in 2007.(1) Even though the mortality rate related to pediatric anesthesia is much lower than before, respiratory complications related with peri-operative cardiac arrest are as high as 27% according to the Pediatric Peri-operative Cardiac Arrest (POCA) Registry.(2).Therefore, peri-operative respiratory event (PRE) in pediatric anesthesia such as laryngospasm, stridor, bronchospasm, desaturation and reintubation are crucial. Stridor and reintubation occur after the children are extubated, mostly in the PACU period. Laryngospasm, stridor, bronchospasm and wheezing can lead to desaturation and the need for reintubation. Those PRE, especially peri-operative desaturation, can prolong PACU stay especially if PRE develops in the PACU.(8,9) PRE occurring during the intraoperative period can also prolong PACU stay if children are observed at PACU and not transferred directly to the intensive care unit (ICU). Some children require oxygen therapy in the PACU and continue at the ward. Some need endotracheal tube intubation with spontaneous breathing or are placed on mechanical ventilator. Thai AIMS (10) reported that desaturation at PACU was associated with re-intubation, prolonged mechanical ventilation and unplanned ICU admission. Oxygen supplement need, prolonged mechanical ventilation or unplanned ICU admission can produce extra days of hospitalization or increase the cost of hospitalization from extra-cost payment eg; oxygen therapy, mechanical ventilator, cost of ICU stayed. Furthermore, the short-term sequelae regarding cost of hospitalization of children who develop PRE has never been evaluated or compared with the cost in children who do not develop PRE. Higher cost of hospitalization after occurrence of PRE in anesthetized children will have an impact to the hospital policy maker. Minimizing PRE can save on the cost of hospital care to the public hospital or other health sectors. Therefore, we would like to compare days of hospitalization and cost differences of hospitalization between children who develop PRE and children who do not develop PRE at a tertiary care hospital in southern Thailand

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,004

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 14, 2014

Completed
Last Updated

October 31, 2014

Status Verified

October 1, 2014

Enrollment Period

1.2 years

First QC Date

January 11, 2014

Last Update Submit

October 30, 2014

Conditions

Keywords

pediatric anesthesiaperioperative respiratory eventsdays of hospitalizationcost of hospitalization

Outcome Measures

Primary Outcomes (1)

  • cost of hospitalization

    November 2012-January 2014

    15 months

Secondary Outcomes (1)

  • days of hospitalization

    15 months

Study Arms (1)

PRE/non-PRE

children who develop or did not perioperative respiratory events between November 2012 and December 2013

Eligibility Criteria

Age1 Day - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children aged \< 15 years who received general anesthesia in Songklanagarind Hospital between November 2012 and December 2013

You may qualify if:

  • Children aged \< 15 years who received general anesthesia and developed PRE or who had no PRE in Songklanagarind Hospital between November 2012 and December 2013

You may not qualify if:

  • ASA classification 4 or 5
  • Preoperative SpO2 \< 95% at room air
  • Required preoperative endotracheal tube intubation (ETT) or mechanical ventilation
  • Had congenital cyanotic heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Related Publications (1)

  • Oofuvong M, Geater AF, Chongsuvivatwong V, Chanchayanon T, Sriyanaluk B, Suwanrat B, Nuanjun K. Does perioperative respiratory event increase length of hospital stay and hospital cost in pediatric ambulatory surgery? PLoS One. 2021 May 13;16(5):e0251433. doi: 10.1371/journal.pone.0251433. eCollection 2021.

Study Officials

  • Maliwan Oofuvong, MD

    Prince of Songkla University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Anesthesiology

Study Record Dates

First Submitted

January 11, 2014

First Posted

January 14, 2014

Study Start

November 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

October 31, 2014

Record last verified: 2014-10

Locations