LaryngospasmPhase 3NCT01288248
Noninferiority Clinical Trial With Laryngeal Mask and Endotracheal Tube
A Phase 3 study testing Airway laryngeal mask classic and endotracheal tube in people with Laryngospasm and Bradycardia, run by Universidad de Antioquia at 1 site in Colombia.
Trial summary
The purpose of this study is to determine whether the use of laryngeal mask classic as method for securing the airway in the population of 2 years to 14 years is associated with risk of laryngospasm as compared with the use of endotracheal tube. Read more about this study
- Who is it for?
- Ages 2 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Laryngospasm, Bradycardia
- What is being tested?
- Airway laryngeal mask classic and endotracheal tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 1 siteColombia
- Study dates
- Jan 2012to Dec 2013
- Phase
- Phase 3
- 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 2 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- ASA I and III children, 1-14 years of age
- Children scheduled for surgery or therapeutic procedures under general anesthesia and fasting as defined in the fasting guidelines
- Responsible adult patients whose accept and sign the informed consent of study
Who cannot join
- Surgery of the head, neck, chest and/or abdomen (except the abdominal wall)
- Position different than the supine in surgery
- Malformations or anatomic abnormalities of the face and airway
- Procedures over 3 hours
- Patients with pulmonary aspiration risk: morbid obesity, intestinal obstruction, gastrointestinal bleeding, gastroparesis, gastroesophageal reflux
- Patients with limited mouth opening or cervical spine extension and classified as difficult airway
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Hospital Foundation St. Vincent de Paul
Medellín, Antioquia, 05001000
About this study
Official title: The Risk of Laryngospasm in Children is Similar to the Use of the Laryngeal Mask and the Endotracheal Tube in Children 2 Years to 14 Years: Clinical Trial Randomized Noninferiority
The purpose of this study is to determine whether the use of laryngeal mask classic as method for securing the airway in the population of 2 years to 14 years is associated with risk of laryngospasm as compared with the use of endotracheal tube.
Read the detailed description
Laryngospasm, defined as closure of the glottis as a protective reflex secondary to abnormal stimulation (7), with a reported incidence in the general population of 8.7 per 1000 patients undergoing surgical procedures (8), is considered the most common event among the complications in the management of pediatric airway, causing 40% of obstructive events after extubation (7-8), with incidents reported in the American pediatric population from 0.4% to 14% (8-9) for population under 6 years and 3.6% in > 6 years. Among the risk factors associated with the development of laryngospasm and anesthesia in children are: age, ASA (4), upper respiratory infection (10), among others, however in recent years has gained interest and generated dispute the association between this outcome and the type of device used to secure the airway during anesthesia. Although the endotracheal tube device is considered the "gold standard" for airway management, this has been associated with an increased incidence of laryngospasm (8), explained this phenomenon, apparently by direct stimulation because the tube into the larynx and trachea, which triggers, in theory, a posterior laryngeal reflex intense (11).
In recent years, with the advent of new devices for securing the airway, especially supraglottic use type Classic Laryngeal Mask (LM), it was thought that the main trigger of laryngospasm, laryngeal and tracheal stimulation caused by the endotracheal tube (ETT), would be resolved and will decrease the incidence of complications in the pediatric population; however, three recent prospective studies (10-11-12) is no statistically significant difference in incidence of laryngospasm among laryngeal mask and endotracheal tube. By contrast, two retrospective studies (6.4) have shown increased incidence of laryngospasm compared to ETT in children. In 2002, one of the aforementioned prospective studies (11), found an incidence of laryngospasm 11.2% versus 16.9% for ETT versus ML, respectively, but without an increase in relative risk statistically significant when comparing the ML to ETT.
In view of these findings and considering that most studies in this respect seem to have technical and methodological limitations, our objective is to determine by controlled clinical trial non inferiority the risk of laryngospasm with the endotracheal tube vs a device supraglottic, Classic Laryngeal Mask type as a method of airway patency in the pediatric population, assuming that the risk of laryngospasm with both devices is equal.
- Conditions
- Laryngospasm, Bradycardia
- Being tested
- Airway laryngeal mask classic, endotracheal tube
- Keywords
- Airway, Airway laryngeal mask, Endotracheal tube, Respiration artificial, Laryngospasm, Safety of airway laryngeal mask
- Medical subject headings
- Laryngismus, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway laryngeal mask classicDevice
Also called airway laryngeal mask proseal
This group includes patients with the randomization process are assigned to use Classic laryngeal mask as a method to secure the airway after induction of anesthesia, which will be maintained during surgery and removed the patient asleep once you are done the surgical procedure to determine the presence or absence of laryngospasm.
The laryngeal mask mark to be used will laryngeal Mask Device ® which comes in different sizes and sterilized in ethylene oxide. The size of the Classic laryngeal mask is used according to the weight assigned
endotracheal tubeDevice
Also called laryngeal tube
This group includes patients with the randomization process are allocated to use endotracheal tube method for securing the airway after induction of anesthesia, which will be maintained during surgery and removed in the awake patient when you finish the surgical procedure to determine the presence or absence of laryngospasm.
The marks of the endotracheal tube will be one of the following: Kendall Curity ®, Well Lead Medical ®, Meditec ®, which are not reusable. The size of the endotracheal tube be allocated according to age.
| Study group | Role | What they receive |
|---|---|---|
| Airway laryngeal mask classic | Experimental | Ventilation with Airway laryngeal mask classic during surgery Receives: Device: Airway laryngeal mask classic |
| endotracheal tube | Active comparator | Ventilation with endotracheal tube during surgery Receives: Device: endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laryngospasm clinically manifested as inspiratory stridor and/or expiratory, no breath sounds, paradoxical movement of the thorax and abdomen and desaturation, bradycardia, central cyanosis.
It should be noted that once the subject of study presents the primary outcome may end up changing the device to improve ventilation.
Measured: The appearance of the outcome will be measured from anesthetic induction until the patient is fully awake
Secondary outcomes (2)
Desaturation defined as SaO2 < 90% in pulse oximetry associated with laryngospasm
Measured: from anesthetic induction until the patient is fully awake
Presence of bradycardia in the cardioscope as reported for the age.
Measured: from anesthetic induction until the patient is fully awake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2011 (estimated)
- Study startJan 2012
- Primary completionOct 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaryngospasmStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 338 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olga Luci-a Giraldo Salazar, Universidad de Antioquia
- Investigators
- Olga Lucia Giraldo Salazar, MD, MsH, Principal investigator, Foundation Hospital San Vicente de Paul, St. Vincent Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01288248
- Sponsor's protocol ID
- Anestudea-001
- Status last verified
- Jul 2012
- First submitted
- 31 Jan 2011
- Last updated
- 26 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Risk of Laryngospasm in Children is Similar to the Use of the Laryngeal Mask and the Endotracheal Tube in Children 2 Years to 14 Years: Clinical Trial Randomized Noninferiority
- ClinicalTrials.gov ID
- NCT01288248
- Acronym / sponsor ID
- Anestudea-001
- Conditions
- Laryngospasm, Bradycardia
- Keywords
- Airway, Airway laryngeal mask, Endotracheal tube, Respiration artificial, Laryngospasm, Safety of airway laryngeal mask
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 338 participants (estimated)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 2 Feb 2011 (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.
The purpose of this study is to determine whether the use of laryngeal mask classic as method for securing the airway in the population of 2 years to 14 years is associated with risk of laryngospasm as compared with the use of endotracheal tube.
Detailed description
Laryngospasm, defined as closure of the glottis as a protective reflex secondary to abnormal stimulation (7), with a reported incidence in the general population of 8.7 per 1000 patients undergoing surgical procedures (8), is considered the most common event among the complications in the management of pediatric airway, causing 40% of obstructive events after extubation (7-8), with incidents reported in the American pediatric population from 0.4% to 14% (8-9) for population under 6 years and 3.6% in > 6 years. Among the risk factors associated with the development of laryngospasm and anesthesia in children are: age, ASA (4), upper respiratory infection (10), among others, however in recent years has gained interest and generated dispute the association between this outcome and the type of device used to secure the airway during anesthesia. Although the endotracheal tube device is considered the "gold standard" for airway management, this has been associated with an increased incidence of laryngospasm (8), explained this phenomenon, apparently by direct stimulation because the tube into the larynx and trachea, which triggers, in theory, a posterior laryngeal reflex intense (11).
In recent years, with the advent of new devices for securing the airway, especially supraglottic use type Classic Laryngeal Mask (LM), it was thought that the main trigger of laryngospasm, laryngeal and tracheal stimulation caused by the endotracheal tube (ETT), would be resolved and will decrease the incidence of complications in the pediatric population; however, three recent prospective studies (10-11-12) is no statistically significant difference in incidence of laryngospasm among laryngeal mask and endotracheal tube. By contrast, two retrospective studies (6.4) have shown increased incidence of laryngospasm compared to ETT in children. In 2002, one of the aforementioned prospective studies (11), found an incidence of laryngospasm 11.2% versus 16.9% for ETT versus ML, respectively, but without an increase in relative risk statistically significant when comparing the ML to ETT.
In view of these findings and considering that most studies in this respect seem to have technical and methodological limitations, our objective is to determine by controlled clinical trial non inferiority the risk of laryngospasm with the endotracheal tube vs a device supraglottic, Classic Laryngeal Mask type as a method of airway patency in the pediatric population, assuming that the risk of laryngospasm with both devices is equal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Airway laryngeal mask classic | Experimental | Device: Airway laryngeal mask classicVentilation with Airway laryngeal mask classic during surgery |
| endotracheal tube | Active comparator | Device: endotracheal tubeVentilation with endotracheal tube during surgery |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA I and III children, 1-14 years of age
- Children scheduled for surgery or therapeutic procedures under general anesthesia and fasting as defined in the fasting guidelines
- Responsible adult patients whose accept and sign the informed consent of study
Key exclusion criteria (6 listed)
- Surgery of the head, neck, chest and/or abdomen (except the abdominal wall)
- Position different than the supine in surgery
- Malformations or anatomic abnormalities of the face and airway
- Procedures over 3 hours
- Patients with pulmonary aspiration risk: morbid obesity, intestinal obstruction, gastrointestinal bleeding, gastroparesis, gastroesophageal reflux
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 |
|---|---|---|
| Airway laryngeal mask classicAlso: airway laryngeal mask prosealThis group includes patients with the randomization process are assigned to use Classic laryngeal mask as a method to secure the airway after induction of anesthesia, which will be maintained during surgery and removed the patient asleep once you are done the surgical procedure to determine the presence or absence of laryngospasm. The laryngeal mask mark to be used will laryngeal Mask Device ® which comes in different sizes and sterilized in ethylene oxide. The size of the Classic laryngeal mask is used according to the weight assigned | Device | Airway laryngeal mask classic |
| endotracheal tubeAlso: laryngeal tubeThis group includes patients with the randomization process are allocated to use endotracheal tube method for securing the airway after induction of anesthesia, which will be maintained during surgery and removed in the awake patient when you finish the surgical procedure to determine the presence or absence of laryngospasm. The marks of the endotracheal tube will be one of the following: Kendall Curity ®, Well Lead Medical ®, Meditec ®, which are not reusable. The size of the endotracheal tube be allocated according to age. | Device | endotracheal tube |
Primary outcome
Laryngospasm clinically manifested as inspiratory stridor and/or expiratory, no breath sounds, paradoxical movement of the thorax and abdomen and desaturation, bradycardia, central cyanosis.
Time frame: The appearance of the outcome will be measured from anesthetic induction until the patient is fully awake
It should be noted that once the subject of study presents the primary outcome may end up changing the device to improve ventilation.
2 secondary outcomes
Desaturation defined as SaO2 < 90% in pulse oximetry associated with laryngospasm
Time frame: from anesthetic induction until the patient is fully awake
Presence of bradycardia in the cardioscope as reported for the age.
Time frame: from anesthetic induction until the patient is fully awake
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2012.
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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.
Olga Lucia Giraldo Salazar, MD, MsH principal investigator
Foundation Hospital San Vicente de Paul, St. Vincent Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Airway laryngeal mask classic and endotracheal tube in people with Laryngospasm and Bradycardia, run by Universidad de Antioquia at 1 site in Colombia.
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 6 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: status not confirmed, as of the sponsor's last update on 26 Jul 2012. 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 Colombia. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Laryngospasm clinically manifested as inspiratory stridor and/or expiratory, no breath sounds, paradoxical movement of the thorax and abdomen and desaturation, bradycardia, central cyanosis. (time frame: The appearance of the outcome will be measured from anesthetic induction until the patient is fully awake). 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 26 Jul 2012.