Laryngeal Mask Airway RemovalNCT03105739
Timing of Withdrawal of the Laryngeal Mask Airway (LMA) in Children
A study testing LMA removal in people with Laryngeal Mask Airway Removal and Respiratory Complication, run by Hôpital d'enfants Béchir-Hamza at 1 site in Tunisia.
Trial summary
The purpose of this prospective, randomized study was to compare the incidence of adverse events associated with removal of the LMA either in deeply anesthetised or awake patients. Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Laryngeal Mask Airway Removal, Respiratory Complication
- What is being tested?
- LMA removal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteTunisia
- Study dates
- 5 Oct 2016to 30 Mar 2017
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children scheduled for minor surgery
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Hôpital d'Enfants Béchir Hamza
Bab Saadoun, Tunis Governorate, 1029
About this study
Official title: Timing of Withdrawal of the Laryngeal Mask Airway (LMA) in Children: Early or Late Removal?
The purpose of this prospective, randomized study was to compare the incidence of adverse events associated with removal of the LMA either in deeply anesthetised or awake patients.
Read the detailed description
Written informed consent was obtained from parents for this prospective, randomized study conducted on children scheduled for minor surgery. Anesthesia was induced with sevoflurane, supplemented with propofol (3mg/kg) then maintained with nitrous oxide and sevoflurane 2-4% in oxygen. Analgesia was insured by peripheral nerve blocks. Included children were randomized into 2 groups:
- Awake: the LMA was left in place until the patient fully regained consciousness
- Deeply anesthetised: the LMA was immediately removed once the halogenated anesthetic turned off, and ventilation using facial mask was carried until spontaneous ventilation recovery.
Respiratory complications that occurred during LMA removal until 20 minutes afterwards were recorded. Children with respiratory history and those for whom peripheral nerve blocks failed, were excluded.
- Being tested
- LMA removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMA removalOther
According to randomization, LMA device was removed at the end of surgery, either in deeply anesthetised patients or after consciousness recovery.
| Study group | Role | What they receive |
|---|---|---|
| Anesthetised | Experimental | LMA removal once the halogenated anesthetic turned off Receives: Other: LMA removal |
| Awake | Active comparator | LMA removal once the patient fully regained consciousness Receives: Other: LMA removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of respiratory adverse events
Measured: from LMA removal to 20 minutes afterwards
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start5 Oct 2016
- Primary completion29 Mar 2017
- Study completion30 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal Mask Airway RemovalStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital d'enfants Béchir-Hamza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Sonia ben khalifa (PhD), Hôpital d'enfants Béchir-Hamza
- Investigators
- Sonia Ben Khalifa, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105739
- Sponsor's protocol ID
- LMA-001
- Status last verified
- Apr 2017
- First submitted
- 29 Mar 2017
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Withdrawal of the Laryngeal Mask Airway (LMA) in Children: Early or Late Removal?
- ClinicalTrials.gov ID
- NCT03105739
- Acronym / sponsor ID
- LMA-001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Hôpital d'enfants Béchir-HamzaUniversity, hospital or other
- Study start
- 5 Oct 2016
- Primary completion
- 29 Mar 2017 (actual)
- Study completion
- 30 Mar 2017 (actual)
- First posted
- 10 Apr 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.
The purpose of this prospective, randomized study was to compare the incidence of adverse events associated with removal of the LMA either in deeply anesthetised or awake patients.
Detailed description
Written informed consent was obtained from parents for this prospective, randomized study conducted on children scheduled for minor surgery. Anesthesia was induced with sevoflurane, supplemented with propofol (3mg/kg) then maintained with nitrous oxide and sevoflurane 2-4% in oxygen. Analgesia was insured by peripheral nerve blocks. Included children were randomized into 2 groups:
- Awake: the LMA was left in place until the patient fully regained consciousness
- Deeply anesthetised: the LMA was immediately removed once the halogenated anesthetic turned off, and ventilation using facial mask was carried until spontaneous ventilation recovery.
Respiratory complications that occurred during LMA removal until 20 minutes afterwards were recorded. Children with respiratory history and those for whom peripheral nerve blocks failed, were excluded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anesthetised | Experimental | Other: LMA removalLMA removal once the halogenated anesthetic turned off |
| Awake | Active comparator | Other: LMA removalLMA removal once the patient fully regained consciousness |
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children scheduled for minor surgery
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| LMA removalAccording to randomization, LMA device was removed at the end of surgery, either in deeply anesthetised patients or after consciousness recovery. | Other | Anesthetised, Awake |
Primary outcome
Occurence of respiratory adverse events
Time frame: from LMA removal to 20 minutes afterwards
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 10 Apr 2017.
- Individual participant dataSharing planned: No
Related trials for Laryngeal Mask Airway Removal
Not yet recruiting
SafeLM Versus LMA Classic for Airway Management During Fibroadenoma Excision
Airway Management
Not yet recruitingObservational study
Reducing Pneumonia with LMA in Lung Wedge Resection
Pneumonia, Postoperative, Anesthesia
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.
Sonia Ben Khalifa, PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LMA removal in people with Laryngeal Mask Airway Removal and Respiratory Complication, run by Hôpital d'enfants Béchir-Hamza at 1 site in Tunisia.
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 1 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 10 Apr 2017. 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 Tunisia. 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?
Occurence of respiratory adverse events (time frame: from LMA removal to 20 minutes afterwards). 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 10 Apr 2017.