HospitalizationNCT02036021
Cost of Hospitalization in Children Who Develop Perioperative Respiratory Event
An observational study of Hospitalization and Cost of Illness, run by Prince of Songkla University at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 14 years
- Conditions the study is for
- Hospitalization, Cost of Illness
- How many people
- 1,004 participants
- Where
- 1 siteThailand
- Study dates
- Nov 2012to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged < 15 years who received general anesthesia in Songklanagarind Hospital between November 2012 and December 2013
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
About this study
Official title: Comparison of Cost of Hospitalization in Children After General Anesthesia With and Without Perioperative Respiratory Event at a Tertiary Care Hospital in Southern Thailand
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.
Read more
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
Read the detailed description
- Study design A prospective observational study
- Study setting Children aged < 15 years who received general anesthesia in Songklanagarind Hospital between November 2012 and December 2013
- Study samples Inclusion criteria 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.
Exclusion criteria
- 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
- Study size Sample size calculation The sample size calculation is based on a comparison between groups of the outcomes of days and cost of hospitalization between PRE and non-PRE group 5. Sampling technique Purposive identification of children aged < 15 years old who receive general anesthesia and develop Peri-operative respiratory event (PRE) between November 2012 and December 2013.was selected for PRE or exposed group. Peri-operative respiratory event (PRE) is defined as any respiratory event eg; laryngospasm, stridor, wheezing, bronchospasm, reintubation, with or without desaturation, which occurs during the intraoperative or PACU period. For non-PRE or non-exposed group, the matching with exposed group on the same demographic data will be performed as below.
- Matching on the same year of anesthesia
- Matching on the same type of surgery
- Matching on the same type of anesthesia After matching the same type of surgery and anesthesia with exposed group, non-exposed group will be randomly selected by simple random sampling technique if there are more than 4 suitable non-exposed subjects available. The ratio of exposed group and non-exposed group will be 1 to 4. 6 Outcome variables The outcome variables are divided into days of hospitalization and cost of hospitalization.
Days of hospitalization Days of hospitalization is the days that the children stay in the hospital until discharge home Days of hospitalization will be compared between PRE group and non-PRE group Cost of hospitalization Cost of hospitalization is the total cost of hospitalization including direct and indirect costs (25,26)
- Direct cost are the hospital charge multiplied by cost-to-charge ratio (CCR)
- Hospital charges are all the medical cost including medication, procedure related with anesthesia or surgery, material cost related with procedure, extra-cost from complication postoperatively: ICU stay, cost of ventilator or oxygen therapy, accommodation and meals charge
- Indirect costs are the cost including transportation (T), productivity loss eg; cost of work leave (L)/day Therefore, cost of hospitalization
- (hospital charge* CCR) + T + (L* days of hospitalization) According to the payer perspective, the CCR is equal to 1 Cost of hospitalization will be compared between PRE group and non-PRE group. The total cost of hospitalization from each group is a transfer payment not a real payment because 80% of the hospital charge is subsidized with the insurance coverage by government eg; universal coverage (UC), social security, government corporation or Comptroller General Department, which cannot reflect the societal cost. Moreover, we do not consider the cost of hospitalization following the disease related groups (DRG) payment in this project.
- Independent variables Patient related factors
- Age
- Sex
- Weight
- Height
- ASA classification
- History of upper respiratory tract infection
- History of parental smoking
- History of snoring: yes vs no
- Postoperative complications - Related to surgery
- Related to anesthesia
- Related to anesthesia and surgery Anesthetic related factors
- Type of surgery 2. Choice of general anesthesia 3. Technique of general anesthesia 4. Induction agent 5. Intubation agent 6. Inhalation agent used 7. Gas mixed with oxygen used 8. Type of narcotic 9. Duration of anesthesia 10. Period of PACU stayed 11. Developed any respiratory events : Yes vs no 12. Peri-operative respiratory event 13. The period of respiratory events developed : intraoperative vs PACU 14. The lowest oxygen saturation of respiratory events developed 15. Postoperative on oxygen therapy 16. Postoperative on mechanical ventilation
- Data processing and analysis Descriptive component Analysis will be performed with the R program version 2.14.1. Descriptive statistics will be computed for all variables and include frequency, proportion, mean + SD and median (range). Predictor variables will be categorical data either originally or if continuous, categorized by selected suitable cut points.
Analytic component The days of hospitalization will be compared between PRE and non-PRE group using simple linear regression model. The other explanatory variables that may be related to prolonged hospitalization will be analyzed using multiple linear regression models if showing some evidence of differing across outcome categories in univariate analysis (p ≤ 0.2). The magnitudes and precision of associations will be indicated by adjusted coefficient and their 95% confidence intervals.
Total cost of hospitalization will be compared between PRE and non-PRE group using simple linear regression model. Cost of hospitalization will be calculated both using CCR 0.4 (hospital perspective) and 1 (payer perspective). The other explanatory variables that may be related to higher cost of hospitalization will be analyzed using multiple linear regression models if showing some evidence of differing across outcome categories in univariate analysis (p ≤ 0.2). The magnitudes and precision of associations will be indicated by adjusted coefficient and their 95% confidence intervals.
For both days and cost of hospitalization, if the distribution is not suitable for linear regression or the assumption of linear regression is not met, the other alternative analysis methods may be preferred eg; logarithmic transform, quantile regression or Cox regression.
In multivariate modeling techniques, association with outcome will be considered significant if the likelihood ratio p-values are ≤ 0.05.
- Conditions
- Hospitalization, Cost of Illness
- Keywords
- pediatric anesthesia, perioperative respiratory events, days of hospitalization, cost of hospitalization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PRE/non-PRE | children who develop or did not perioperative respiratory events between November 2012 and December 2013 |
What is being measured
The primary outcome is the main question the study is designed to answer.
cost of hospitalization
November 2012-January 2014
Measured: 15 months
Secondary outcomes (1)
days of hospitalization
November 2012-January 2014
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startNov 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HospitalizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,004 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Collaborators
- The Royal Golden Jubilee PhD funding of Thailand
- Responsible party
- Principal investigator, maliwan oofuvong, Prince of Songkla University
- Investigators
- Maliwan Oofuvong, MD, Principal investigator, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036021
- Sponsor's protocol ID
- cost904
- Status last verified
- Oct 2014
- First submitted
- 11 Jan 2014
- Last updated
- 31 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33984031
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cost of Hospitalization in Children After General Anesthesia With and Without Perioperative Respiratory Event at a Tertiary Care Hospital in Southern Thailand
- ClinicalTrials.gov ID
- NCT02036021
- Acronym / sponsor ID
- cost904
- Conditions
- Hospitalization, Cost of Illness
- Keywords
- pediatric anesthesia, perioperative respiratory events, days of hospitalization, cost of hospitalization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,004 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Collaborators
- The Royal Golden Jubilee PhD funding of Thailand
- Study start
- Nov 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 14 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
- Study design A prospective observational study
- Study setting Children aged < 15 years who received general anesthesia in Songklanagarind Hospital between November 2012 and December 2013
- Study samples Inclusion criteria 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.
Exclusion criteria
- 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
- Study size Sample size calculation The sample size calculation is based on a comparison between groups of the outcomes of days and cost of hospitalization between PRE and non-PRE group 5. Sampling technique Purposive identification of children aged < 15 years old who receive general anesthesia and develop Peri-operative respiratory event (PRE) between November 2012 and December 2013.was selected for PRE or exposed group. Peri-operative respiratory event (PRE) is defined as any respiratory event eg; laryngospasm, stridor, wheezing, bronchospasm, reintubation, with or without desaturation, which occurs during the intraoperative or PACU period. For non-PRE or non-exposed group, the matching with exposed group on the same demographic data will be performed as below.
- Matching on the same year of anesthesia
- Matching on the same type of surgery
- Matching on the same type of anesthesia After matching the same type of surgery and anesthesia with exposed group, non-exposed group will be randomly selected by simple random sampling technique if there are more than 4 suitable non-exposed subjects available. The ratio of exposed group and non-exposed group will be 1 to 4. 6 Outcome variables The outcome variables are divided into days of hospitalization and cost of hospitalization.
Days of hospitalization Days of hospitalization is the days that the children stay in the hospital until discharge home Days of hospitalization will be compared between PRE group and non-PRE group Cost of hospitalization Cost of hospitalization is the total cost of hospitalization including direct and indirect costs (25,26)
- Direct cost are the hospital charge multiplied by cost-to-charge ratio (CCR)
- Hospital charges are all the medical cost including medication, procedure related with anesthesia or surgery, material cost related with procedure, extra-cost from complication postoperatively: ICU stay, cost of ventilator or oxygen therapy, accommodation and meals charge
- Indirect costs are the cost including transportation (T), productivity loss eg; cost of work leave (L)/day Therefore, cost of hospitalization
- (hospital charge* CCR) + T + (L* days of hospitalization) According to the payer perspective, the CCR is equal to 1 Cost of hospitalization will be compared between PRE group and non-PRE group. The total cost of hospitalization from each group is a transfer payment not a real payment because 80% of the hospital charge is subsidized with the insurance coverage by government eg; universal coverage (UC), social security, government corporation or Comptroller General Department, which cannot reflect the societal cost. Moreover, we do not consider the cost of hospitalization following the disease related groups (DRG) payment in this project.
- Independent variables Patient related factors
- Age
- Sex
- Weight
- Height
- ASA classification
- History of upper respiratory tract infection
- History of parental smoking
- History of snoring: yes vs no
- Postoperative complications - Related to surgery
- Related to anesthesia
- Related to anesthesia and surgery Anesthetic related factors
- Type of surgery 2. Choice of general anesthesia 3. Technique of general anesthesia 4. Induction agent 5. Intubation agent 6. Inhalation agent used 7. Gas mixed with oxygen used 8. Type of narcotic 9. Duration of anesthesia 10. Period of PACU stayed 11. Developed any respiratory events : Yes vs no 12. Peri-operative respiratory event 13. The period of respiratory events developed : intraoperative vs PACU 14. The lowest oxygen saturation of respiratory events developed 15. Postoperative on oxygen therapy 16. Postoperative on mechanical ventilation
- Data processing and analysis Descriptive component Analysis will be performed with the R program version 2.14.1. Descriptive statistics will be computed for all variables and include frequency, proportion, mean + SD and median (range). Predictor variables will be categorical data either originally or if continuous, categorized by selected suitable cut points.
Analytic component The days of hospitalization will be compared between PRE and non-PRE group using simple linear regression model. The other explanatory variables that may be related to prolonged hospitalization will be analyzed using multiple linear regression models if showing some evidence of differing across outcome categories in univariate analysis (p ≤ 0.2). The magnitudes and precision of associations will be indicated by adjusted coefficient and their 95% confidence intervals.
Total cost of hospitalization will be compared between PRE and non-PRE group using simple linear regression model. Cost of hospitalization will be calculated both using CCR 0.4 (hospital perspective) and 1 (payer perspective). The other explanatory variables that may be related to higher cost of hospitalization will be analyzed using multiple linear regression models if showing some evidence of differing across outcome categories in univariate analysis (p ≤ 0.2). The magnitudes and precision of associations will be indicated by adjusted coefficient and their 95% confidence intervals.
For both days and cost of hospitalization, if the distribution is not suitable for linear regression or the assumption of linear regression is not met, the other alternative analysis methods may be preferred eg; logarithmic transform, quantile regression or Cox regression.
In multivariate modeling techniques, association with outcome will be considered significant if the likelihood ratio p-values are ≤ 0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRE/non-PRE | – | –children who develop or did not perioperative respiratory events between November 2012 and December 2013 |
Who may qualify
- Ages
- 1 day to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged < 15 years who received general anesthesia in Songklanagarind Hospital between November 2012 and December 2013
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cost of hospitalization
Time frame: 15 months
November 2012-January 2014
1 secondary outcome
days of hospitalization
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2014.
- Derived from this study: PubMed 33984031Oofuvong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maliwan Oofuvong, MD principal investigator
Prince of Songkla University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hospitalization and Cost of Illness, run by Prince of Songkla University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cost of hospitalization (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02036021, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2014.