Perioperative HypotensionNCT00231699
A Comparison of Prevention of Hypothermia in Pediatric Patient Between Wrapping With Cotton and Plastic.
A study of Perioperative Hypotension and Prevention, run by Khon Kaen University at 1 site in Thailand.
Trial summary
Hypothermia leads to increased morbidity and mortality. Heat loss mainly occurs during anesthesia and surgery. Therefore prevention of hypothermia in pediatric patients undergoing general anesthesia is very important. Read more about this study
- Who is it for?
- Ages 1 month to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Perioperative Hypotension, Prevention, Child
- Type of treatment
- Surgery or procedure
- How many people
- 42 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2004to Dec 2004
- Phase
- Interventional
- 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 month to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 42 pediatric patients (age 1 month-3 years
- ASA physical status 1-2) who were scheduled for elective maxillofacial or genitourinary surgery.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Prevention of Hypothermia in Pediatric Patient Between Wrapping With Cotton (Webril) and Plastic (Mwrap).
Hypothermia leads to increased morbidity and mortality. Heat loss mainly occurs during anesthesia and surgery. Therefore prevention of hypothermia in pediatric patients undergoing general anesthesia is very important. However, there is very little information about effectiveness of various insulating materials used in the operating room.
Objective: To compare the effectiveness of cotton and plastic for prevent intraoperative hypothermia in pediatric patients.
Read the detailed description
A randomized controlled trial was conducted in 42 pediatric patients (age 1 month-3 years, ASA physical status 1-2) who were scheduled for elective maxillofacial or genitourinary surgery. The patients were randomly allocated into 2 groups. The patient's arms, legs and bodies were wrapped with either plastic (study group) or cotton (control group). All patients received standard general anesthesia with endotracheal tube and control ventilation with a fresh gas flow at 1 l/min. The core temperature (rectal temperature) was recorded every 10 minutes for 60 minutes.
- Conditions
- Perioperative Hypotension, Prevention, Child
- Being tested
- Plastic wrap (study group) and cotton (control group) wrap.
- Keywords
- Prevention of Hypothermia, Pediatric Patient, Cotton, Plastic wrap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plastic wrap (study group) and cotton (control group) wrap.Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Core temperature
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startJan 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative HypotensionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 42 participants
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Investigators
- waraporn chau-in, Asso Prof., Principal investigator, Faculty of Medicine,KhonKaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00231699
- Sponsor's protocol ID
- Prevention of Hypothermia
- Status last verified
- Oct 2005
- First submitted
- 3 Oct 2005
- Last updated
- 4 Oct 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Prevention of Hypothermia in Pediatric Patient Between Wrapping With Cotton (Webril) and Plastic (Mwrap).
- ClinicalTrials.gov ID
- NCT00231699
- Acronym / sponsor ID
- Prevention of Hypothermia
- Conditions
- Perioperative Hypotension, Prevention, Child
- Keywords
- Prevention of Hypothermia, Pediatric Patient, Cotton, Plastic wrap
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- Dec 2004
- First posted
- 4 Oct 2005 (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.
Hypothermia leads to increased morbidity and mortality. Heat loss mainly occurs during anesthesia and surgery. Therefore prevention of hypothermia in pediatric patients undergoing general anesthesia is very important. However, there is very little information about effectiveness of various insulating materials used in the operating room.
Objective: To compare the effectiveness of cotton and plastic for prevent intraoperative hypothermia in pediatric patients.
Detailed description
A randomized controlled trial was conducted in 42 pediatric patients (age 1 month-3 years, ASA physical status 1-2) who were scheduled for elective maxillofacial or genitourinary surgery. The patients were randomly allocated into 2 groups. The patient's arms, legs and bodies were wrapped with either plastic (study group) or cotton (control group). All patients received standard general anesthesia with endotracheal tube and control ventilation with a fresh gas flow at 1 l/min. The core temperature (rectal temperature) was recorded every 10 minutes for 60 minutes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 1 month to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 42 pediatric patients (age 1 month-3 years
- ASA physical status 1-2) who were scheduled for elective maxillofacial or genitourinary surgery.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plastic wrap (study group) and cotton (control group) wrap. | Procedure or surgery | – |
Primary outcome
Core temperature
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 4 Oct 2005.
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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.
waraporn chau-in, Asso Prof. principal investigator
Faculty of Medicine,KhonKaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Perioperative Hypotension and Prevention, run by Khon Kaen 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 2 inclusion and 0 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 4 Oct 2005. 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?
Core temperature. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2005.