CatheterizationNCT03254303
Intravenous Cannulation In Children During Sevoflurane Induction
A study testing Difficulty of catheterization in group 60 s, Difficulty of catheterization in group 90 s and Difficulty of catheterization in group 120 s in people with Catheterization, run by Leila mansali stambouli.
Trial summary
This interventional simple-blind,randomized trial has included 90 children of American Society of Anesthesiologist (ASA) physical status I or II aged between 1 to 12 years of either sex, scheduled for for outpatient minor surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Catheterization
- What is being tested?
- Difficulty of catheterization in group 60 s, Difficulty of catheterization in group 90 s and Difficulty of catheterization in group 120 s
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2016to 31 Oct 2016
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children with American Society of Anesthesiologist (ASA) physical status I or II
- age between 1 and 12 years of either sex,
- were scheduled for outpatient minor surgery under general anesthesia
Who cannot join
- age <1 and >12 years
- patients with full stomach
- a history of gastric reflux
- history of convulsions, cardiovascular or neuromuscular disease
- suspected difficult airway and hyper-reactive airway disease
About this study
Official title: Intravenous Cannulation In Children During Sevoflurane Induction: Which Time is Adequate
This interventional simple-blind,randomized trial has included 90 children of American Society of Anesthesiologist (ASA) physical status I or II aged between 1 to 12 years of either sex, scheduled for for outpatient minor surgery under general anesthesia. This study examined whether one should make iv attempts during the early induction period (at 60 seconds) or lately (90 or 120 s) and waiting until the child receives additional sevoflurane inhalation anesthesia.
Read the detailed description
We conducted a prospective randomized study, after obtaining Institutional review board approval, which didn't require written parental consent. Children age 1-12 years, undergoing elective general anesthesia via an inhalation induction were randomized to one of three groups of 30 patients each one, for iv placement, either 60s (group E), 90 or 120 s (group L) following loss of lid reflex. Movement on iv placement and incidence of laryngospasm were determined. Difficulty with iv placement was also recorded. Statistical analysis included contingency testing, ANOVA, and non parametric testing. A P-value <0.05 was considered significant.
- Conditions
- Catheterization
- Being tested
- Difficulty of catheterization in group 60 s, Difficulty of catheterization in group 90 s, Difficulty of catheterization in group 120 s
- Keywords
- Sevoflurane, Catheterization, Anesthetics Inhalation, child
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Difficulty of catheterization in group 60 sOther
Difficulty of catheterization in group 90 sOther
Difficulty of catheterization in group 120 sOther
| Study group | Role | What they receive |
|---|---|---|
| 60s (group E) | Other | The Time of catheterization at 60s (group E) was applied in this study group,after sevoflurane inhalation induction, 30 children have a catheterization after a time of 60 seconds following the eye closure and the loss of lid reflex.Difficulty with intravenous catheterization, limb movement and laryngospasm were recorded.Difficulty of catheterization in group 60 s Receives: Other: Difficulty of catheterization in group 60 s |
| 90s (groupe L) | Other | In this study group,after sevoflurane inhalation induction, 30 children have a catheterization after a time of 90 seconds following the eye closure and the loss of lid reflex.Difficulty with intravenous catheterization, limb movement and laryngospasm were recorded.Difficulty of catheterization in group 90 s Receives: Other: Difficulty of catheterization in group 90 s |
| 120s (groupe L) | Other | In this study group,after sevoflurane inhalation induction, 30 children have a catheterization after a time of 120 seconds following the eye closure and the loss of lid reflex.Difficulty with intravenous catheterization, limb movement and laryngospasm were recorded.Difficulty of catheterization in group 120 s Receives: Other: Difficulty of catheterization in group 120 s |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of intravenous insertion
success insertion of intravenous cannula was achieved at the first attempt less than 30 seconds
Measured: from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds
Secondary outcomes (1)
limb movement
The movement was classified using the scale:
(0 No movement, 1 movement) The incidence of laryngospasm was defined as the sudden complete or partial loss of air exchange with concurrent loss of a capnographic wave.
The movement was classified using the scale:
(0 No movement, 1 movement) The incidence of laryngospasm was defined as the sudden complete or partial loss of air exchange with concurrent loss of a capnographic wave.
- The movement was classified using the scale: (0 No movement, 1 movement)
- The movement was classified using the scale: (0 No movement, 1 movement) The limb movement was classified using the scale:0 No movement, 1 movement)
Measured: from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start1 Aug 2016
- Primary completion31 Oct 2016
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CatheterizationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized and crossover assignemnt
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leila mansali stambouli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Leila mansali stambouli, University of Monastir
- Investigators
- leila Mansali Stambouli, MD PhD, Principal investigator, University Hospital of Fattouma Bourguiba Monastir TUNISIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254303
- Sponsor's protocol ID
- OMB: 0925-0586
- Status last verified
- Aug 2017
- First submitted
- 11 Aug 2017
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choudhry DK, Stayer SA, Schwartz RE, Pasquariello CA. Early intravenous cannulation in children during inhalational induction of anaesthesia. Paediatr Anaesth. 1998;8(2):123-6. doi: 10.1046/j.1460-9592.1998.00731.x.
PubMed 9549737Schwartz D, Connelly NR, Gutta S, Freeman K, Gibson C. Early intravenous cannulation in children during sevoflurane induction. Paediatr Anaesth. 2004 Oct;14(10):820-4. doi: 10.1111/j.1460-9592.2004.01315.x.
PubMed 15385009
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Cannulation In Children During Sevoflurane Induction: Which Time is Adequate
- ClinicalTrials.gov ID
- NCT03254303
- Acronym / sponsor ID
- OMB: 0925-0586
- Conditions
- Catheterization
- Keywords
- Sevoflurane, Catheterization, Anesthetics Inhalation, child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Leila mansali stambouliUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 18 Aug 2017 (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 interventional simple-blind,randomized trial has included 90 children of American Society of Anesthesiologist (ASA) physical status I or II aged between 1 to 12 years of either sex, scheduled for for outpatient minor surgery under general anesthesia. This study examined whether one should make iv attempts during the early induction period (at 60 seconds) or lately (90 or 120 s) and waiting until the child receives additional sevoflurane inhalation anesthesia.
Detailed description
We conducted a prospective randomized study, after obtaining Institutional review board approval, which didn't require written parental consent. Children age 1-12 years, undergoing elective general anesthesia via an inhalation induction were randomized to one of three groups of 30 patients each one, for iv placement, either 60s (group E), 90 or 120 s (group L) following loss of lid reflex. Movement on iv placement and incidence of laryngospasm were determined. Difficulty with iv placement was also recorded. Statistical analysis included contingency testing, ANOVA, and non parametric testing. A P-value <0.05 was considered significant.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- randomized and crossover assignemnt
| Arm | Type | Receives |
|---|---|---|
| 60s (group E) | Other | Other: Difficulty of catheterization in group 60 sThe Time of catheterization at 60s (group E) was applied in this study group,after sevoflurane inhalation induction, 30 children have a catheterization after a time of 60 seconds following the eye closure and the loss of lid reflex.Difficulty with intravenous catheterization, limb movement and laryngospasm were recorded.Difficulty of catheterization in group 60 s |
| 90s (groupe L) | Other | Other: Difficulty of catheterization in group 90 sIn this study group,after sevoflurane inhalation induction, 30 children have a catheterization after a time of 90 seconds following the eye closure and the loss of lid reflex.Difficulty with intravenous catheterization, limb movement and laryngospasm were recorded.Difficulty of catheterization in group 90 s |
| 120s (groupe L) | Other | Other: Difficulty of catheterization in group 120 sIn this study group,after sevoflurane inhalation induction, 30 children have a catheterization after a time of 120 seconds following the eye closure and the loss of lid reflex.Difficulty with intravenous catheterization, limb movement and laryngospasm were recorded.Difficulty of catheterization in group 120 s |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children with American Society of Anesthesiologist (ASA) physical status I or II
- age between 1 and 12 years of either sex,
- were scheduled for outpatient minor surgery under general anesthesia
Key exclusion criteria (5 listed)
- age <1 and >12 years
- patients with full stomach
- a history of gastric reflux
- history of convulsions, cardiovascular or neuromuscular disease
- suspected difficult airway and hyper-reactive airway disease
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 |
|---|---|---|
| Difficulty of catheterization in group 60 s | Other | 60s (group E) |
| Difficulty of catheterization in group 90 s | Other | 90s (groupe L) |
| Difficulty of catheterization in group 120 s | Other | 120s (groupe L) |
Primary outcome
Success of intravenous insertion
Time frame: from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds
success insertion of intravenous cannula was achieved at the first attempt less than 30 seconds
1 secondary outcome
limb movement
Time frame: from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds
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 18 Aug 2017.
- Background: PubMed 9549737Choudhry DK, Stayer SA, Schwartz RE, Pasquariello CA. Early intravenous cannulation in children during inhalational induction of anaesthesia. Paediatr Anaesth. 1998;8(2):123-6. doi: 10.1046/j.1460-9592.1998.00731.x.
- Results publication: PubMed 15385009Schwartz D, Connelly NR, Gutta S, Freeman K, Gibson C. Early intravenous cannulation in children during sevoflurane induction. Paediatr Anaesth. 2004 Oct;14(10):820-4. doi: 10.1111/j.1460-9592.2004.01315.x.
- Individual participant dataSharing planned: No
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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.
leila Mansali Stambouli, MD PhD principal investigator
University Hospital of Fattouma Bourguiba Monastir TUNISIA
Questions about this trial
What is this clinical trial studying?
A study testing Difficulty of catheterization in group 60 s, Difficulty of catheterization in group 90 s and Difficulty of catheterization in group 120 s in people with Catheterization, run by Leila mansali stambouli.
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 3 inclusion and 5 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 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Success of intravenous insertion (time frame: from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds). 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 NCT03254303, which also lists 2 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 18 Aug 2017.