Predicting Uncuffed Endotracheal Tube Size in Pediatric AnesthesiaNCT04869410
Comparison of Modified Broselow Tape and Cole Formula
A study testing Modification Broselow Tape and Cole Formula in people with Predicting Uncuffed Endotracheal Tube Size in Pediatric Anesthesia, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This study aimed to determine the accuracy of modified Broselow tape measurements compared to Cole formula in predicting the size of uncuffed endotracheal tubes in Indonesian pediatrics Read more about this study
- Who is it for?
- Ages 1 year to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Predicting Uncuffed Endotracheal Tube Size in Pediatric Anesthesia
- What is being tested?
- Modification Broselow Tape and Cole Formula
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteIndonesia
- Study dates
- 15 Aug 2018to 10 Jan 2019
- 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 year to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- pediatrics aged 1 - 6 y o
- ASA I-II
- patients went through elective surgery with Genaral anesthesia
- Need to intubated with uncuffed ETT
Who cannot join
- patients with growth and development disorders
- patients whom height that was out of range in modified Broselow tape
- patients with possible airway difficulty or obstruction
- patients with respiratory diseases, underweight and obese
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Broselow Tape and Cole Formulation in Predicting Uncuffed Endotracheal Tube Size in Pediatric Patients
This study aimed to determine the accuracy of modified Broselow tape measurements compared to Cole formula in predicting the size of uncuffed endotracheal tubes in Indonesian pediatrics
Read the detailed description
110 subjects were given informed consent before enrolling the study and randomized into two groups, modified Broselow Tape and Cole formula. Preoperatively, prediction of suitable ETT size was performed based on Cole formula and Modified Broselow Tape. In the operating theatre, general anesthesia induction was performed with sevoflurane 4-8 vol%, fentanyl 2 μcg/kg BW, and atracurium 0.5 mg/kg BW. Laryngoscopy was performed, and an uncuffed polyvinyl chloride endotracheal tubes, whose size was based on the Cole formula, was inserted. An appropriate size of the endotracheal tube was confirmed if the endotracheal tube could go through the cricoid ring smoothly, and no air leakage found when ventilating with an inspiratory pressure of 15-20 cmH2O. The surgery and anesthesia would proceed if the correct size of the endotracheal tube were successfully inserted. If the tube couldn't pass the cricoid smoothly or air leakage was found when ventilated with an inspiratory pressure of 15-20 cmH2O, the endotracheal tube should be replaced with a bigger or smaller size.
- Being tested
- Modification Broselow Tape, Cole Formula
- Keywords
- Uncuffed endotracheal tube, Pediatric, Cole Formula, Broselow Tape
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modification Broselow TapeProcedure or surgery
Intubation using modified Broselow Tape prediction for predicting ETT size
Cole FormulaProcedure or surgery
Intubation using Cole Formula prediction for predicting ETT size
| Study group | Role | What they receive |
|---|---|---|
| Broselow Tape | Active comparator | Patient will given an intubation using uncuffed endotracheal tube size based on Modified Broselow Tape Receives: Procedure: Modification Broselow Tape; Procedure: Cole Formula |
| Cole Formula | Active comparator | Patient will given an intubation using uncuffed endotracheal tube size based on Cole Formula Receives: Procedure: Modification Broselow Tape; Procedure: Cole Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appropriate size of uncuffed endotracheal tube
endotracheal tube could go through the cricoid ring smoothly, and no air leakage found when ventilating with an inspiratory pressure of 15-20 cmH2O
Measured: before procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start15 Aug 2018
- Primary completion18 Oct 2018
- Study completion10 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Predicting Uncuffed Endotracheal Tube Size in Pediatric AnesthesiaStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aida Rosita Tantri, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869410
- Sponsor's protocol ID
- IndonesiaUAnes103
- Status last verified
- Apr 2021
- First submitted
- 28 Apr 2021
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hofer CK, Ganter M, Tucci M, Klaghofer R, Zollinger A. How reliable is length-based determination of body weight and tracheal tube size in the paediatric age group? The Broselow tape reconsidered. Br J Anaesth. 2002 Feb;88(2):283-5. doi: 10.1093/bja/88.2.283.
PubMed 11878662Park HP. Appropriate tube size selection based on radiological images. Korean J Anesthesiol. 2014 Mar;66(3):181-2. doi: 10.4097/kjae.2014.66.3.181. No abstract available.
PubMed 24729837Schramm C, Knop J, Jensen K, Plaschke K. Role of ultrasound compared to age-related formulas for uncuffed endotracheal intubation in a pediatric population. Paediatr Anaesth. 2012 Aug;22(8):781-6. doi: 10.1111/j.1460-9592.2012.03889.x. Epub 2012 May 21.
PubMed 22612446Jang HY, Shin SD, Kwak YH. Can the Broselow tape be used to estimate weight and endotracheal tube size in Korean children? Acad Emerg Med. 2007 May;14(5):489-91. doi: 10.1197/j.aem.2006.12.014. Epub 2007 Mar 23.
PubMed 17384410Shih MH, Chung CY, Su BC, Hung CT, Wong SY, Wong TK. Accuracy of a new body length-based formula for predicting tracheal tube size in Chinese children. Chang Gung Med J. 2008 May-Jun;31(3):276-80.
PubMed 18782950
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Broselow Tape and Cole Formulation in Predicting Uncuffed Endotracheal Tube Size in Pediatric Patients
- ClinicalTrials.gov ID
- NCT04869410
- Acronym / sponsor ID
- IndonesiaUAnes103
- Keywords
- Uncuffed endotracheal tube, Pediatric, Cole Formula, Broselow Tape
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 18 Oct 2018 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 3 May 2021 (actual)
- 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.
This study aimed to determine the accuracy of modified Broselow tape measurements compared to Cole formula in predicting the size of uncuffed endotracheal tubes in Indonesian pediatrics
Detailed description
110 subjects were given informed consent before enrolling the study and randomized into two groups, modified Broselow Tape and Cole formula. Preoperatively, prediction of suitable ETT size was performed based on Cole formula and Modified Broselow Tape. In the operating theatre, general anesthesia induction was performed with sevoflurane 4-8 vol%, fentanyl 2 μcg/kg BW, and atracurium 0.5 mg/kg BW. Laryngoscopy was performed, and an uncuffed polyvinyl chloride endotracheal tubes, whose size was based on the Cole formula, was inserted. An appropriate size of the endotracheal tube was confirmed if the endotracheal tube could go through the cricoid ring smoothly, and no air leakage found when ventilating with an inspiratory pressure of 15-20 cmH2O. The surgery and anesthesia would proceed if the correct size of the endotracheal tube were successfully inserted. If the tube couldn't pass the cricoid smoothly or air leakage was found when ventilated with an inspiratory pressure of 15-20 cmH2O, the endotracheal tube should be replaced with a bigger or smaller size.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Broselow Tape | Active comparator | Procedure: Modification Broselow Tape, Procedure: Cole FormulaPatient will given an intubation using uncuffed endotracheal tube size based on Modified Broselow Tape |
| Cole Formula | Active comparator | Procedure: Modification Broselow Tape, Procedure: Cole FormulaPatient will given an intubation using uncuffed endotracheal tube size based on Cole Formula |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- pediatrics aged 1 - 6 y o
- ASA I-II
- patients went through elective surgery with Genaral anesthesia
- Need to intubated with uncuffed ETT
Key exclusion criteria (4 listed)
- patients with growth and development disorders
- patients whom height that was out of range in modified Broselow tape
- patients with possible airway difficulty or obstruction
- patients with respiratory diseases, underweight and obese
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 |
|---|---|---|
| Modification Broselow TapeIntubation using modified Broselow Tape prediction for predicting ETT size | Procedure or surgery | Broselow Tape, Cole Formula |
| Cole FormulaIntubation using Cole Formula prediction for predicting ETT size | Procedure or surgery | Broselow Tape, Cole Formula |
Primary outcome
Appropriate size of uncuffed endotracheal tube
Time frame: before procedure
endotracheal tube could go through the cricoid ring smoothly, and no air leakage found when ventilating with an inspiratory pressure of 15-20 cmH2O
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 3 May 2021.
- Background: PubMed 11878662Hofer CK, Ganter M, Tucci M, Klaghofer R, Zollinger A. How reliable is length-based determination of body weight and tracheal tube size in the paediatric age group? The Broselow tape reconsidered. Br J Anaesth. 2002 Feb;88(2):283-5. doi: 10.1093/bja/88.2.283.
- Background: PubMed 24729837Park HP. Appropriate tube size selection based on radiological images. Korean J Anesthesiol. 2014 Mar;66(3):181-2. doi: 10.4097/kjae.2014.66.3.181. No abstract available.
- Background: PubMed 22612446Schramm C, Knop J, Jensen K, Plaschke K. Role of ultrasound compared to age-related formulas for uncuffed endotracheal intubation in a pediatric population. Paediatr Anaesth. 2012 Aug;22(8):781-6. doi: 10.1111/j.1460-9592.2012.03889.x. Epub 2012 May 21.
- Background: PubMed 17384410Jang HY, Shin SD, Kwak YH. Can the Broselow tape be used to estimate weight and endotracheal tube size in Korean children? Acad Emerg Med. 2007 May;14(5):489-91. doi: 10.1197/j.aem.2006.12.014. Epub 2007 Mar 23.
- Results publication: PubMed 18782950Shih MH, Chung CY, Su BC, Hung CT, Wong SY, Wong TK. Accuracy of a new body length-based formula for predicting tracheal tube size in Chinese children. Chang Gung Med J. 2008 May-Jun;31(3):276-80.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modification Broselow Tape and Cole Formula in people with Predicting Uncuffed Endotracheal Tube Size in Pediatric Anesthesia, run by Universitas Indonesia at 1 site in Indonesia.
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 4 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 3 May 2021. 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 Indonesia. 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?
Appropriate size of uncuffed endotracheal tube (time frame: before procedure). 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 NCT04869410, which also lists 5 linked publications.
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 3 May 2021.