Airway ManagementNCT03443219
RCT- LMA Supreme™ Versus the Spritztube® Tracheal Cannula in Anesthetized Adult Patients
A study testing Spritztube® and LMA Supreme™ in people with Airway Management, run by St. Bortolo Hospital.
Trial summary
The study compares the LMA Supreme™ versus the Spritztube® tracheal cannula in anesthetized adult patients. The current randomized study is designed to assess the success placement of blind insertion using LMA Supreme™ , in comparison with the Spritztube® tracheal cannula. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Management
- What is being tested?
- Spritztube® and LMA Supreme™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 355 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2016to 20 Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anaesthesiologists (ASA) physical status classification I, II, and III;
- Age > 18 years
- Elective surgery in the supine position
Who cannot join
- Pregnancy
- Age <18 years
- Not eligibility for surgery
- Predicted difficult airway management
- Positive history for esophageal or pharyngeal diseases
- Emergency surgery
About this study
Official title: A Prospective Randomised Controlled Trial of the LMA Supreme™ Versus the Spritztube® Tracheal Cannula in Anesthetized Adult Patients
The study compares the LMA Supreme™ versus the Spritztube® tracheal cannula in anesthetized adult patients.
The current randomized study is designed to assess the success placement of blind insertion using LMA Supreme™ , in comparison with the Spritztube® tracheal cannula.
In addition, time, number of attempts, easy insertion and the number of complications at insertion and removal will be assessed.
The investigators hypothesize that the LMA Supreme™ versus the Spritztube® tracheal cannula will similarly perform during anesthetized adult patients despite differences in their structural design.
Read the detailed description
A new extraglottic airway device, the Spritztube® [tracheal cannula, Med Europe s.r.l], was developed combining the ability to perform both EAD ventilation and oro-tracheal fibreoptic intubation using the same device. The Spritztube® consists of a silicone cannula with two low-pressure cuffs: a proximal cuff, designed to seal the pharynx cranially of the epiglottis and a distal cuff, designed to seal the oesophagus. The positioning of this device requires the aid of a spindle, that keep the cuffs on the same line and it is rigid enough to allow the passage through oropharynx tissue. That can be inserted blindly as extraglottic device or through the use of direct laryngoscopy or fibroscopy as tracheal cannula.
The current randomized study is designed to assess the success placement of blind insertion using LMA Supreme™ , in comparison with the Spritztube® tracheal cannula.
In addition, time, number of attempts, easy insertion and the number of complications at insertion and removal will be assessed.
- Conditions
- Airway Management
- Being tested
- Spritztube®, LMA Supreme™
- Keywords
- Airway Management, Extraglottic airway device, Laryngeal mask airway, Spritztube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spritztube®Device
After preoxygenation, anaesthesia was induced with midazolam, propofol, and fentanyl,Spritztube® was inserted and both cuffs inflated
LMA Supreme™Device
After preoxygenation, anaesthesia was induced with midazolam, propofol, and fentanyl,LMA Supreme™ was inserted and both cuffs inflated
| Study group | Role | What they receive |
|---|---|---|
| Spritztube® | Experimental | The patients were randomly allocated to two groups by using computer-generated numbers.In Spritztube® group, Spritztube® was inserted into each patient after anesthesia induction. Receives: Device: Spritztube® |
| LMA Supreme™ | Active comparator | The patients were randomly allocated to two groups by using computer-generated numbers.In vgroup, LMA Supreme™was inserted into each patient after anesthesia induction. Receives: Device: LMA Supreme™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
the successful placement of device in two groups
A successful intubation attempt was recognized if the breathing circuit was connected, the breath sounds over the lung were present and the End tidal CO2 trace was revealed.
Measured: Intraoperative
Secondary outcomes (5)
Insertion time (in seconds)
The insertion time was measured from the insertion of device into the patient's mouth to connecting the breathing circuit.
Measured: Intraoperative
Number of attempts
If placement had failed after three attempts, the study was abandoned and the airway was maintained through a tracheal tube.
Measured: Intraoperative
Easy to insert
A successful insertion of device in just one attempt
Measured: Intraoperative
number of complications at insertion
air leak at induction, laryngospasm, obstruction after induction, gastric insufflation, failure device
Measured: Intraoperative
number of complications at removal
dysphagia, hoarseness and sore throat
Measured: Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start15 Sep 2016
- Primary completion10 Jul 2017
- Study completion20 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Airway ManagementStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Bortolo Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia De Rosa, St. Bortolo Hospital
- Investigators
- Raffaele Bonato, MD, Study director, Department of Anesthesiology and Intensive Care, San Bortolo Hospital, Vicenza, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443219
- Sponsor's protocol ID
- 29/16
- Status last verified
- Feb 2018
- First submitted
- 12 Feb 2018
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
De Rosa S, Messina A, Sorbello M, Rigobello A, Colombo D, Piccolo A, Bonaldi E, Gennaro P, Urukalo V, Pellizzari A, Bonato R, Carboni SC. Laryngeal Mask Airway Supreme vs. the Spritztube tracheal cannula in anaesthetised adult patients: A randomised controlled trial. Eur J Anaesthesiol. 2019 Dec;36(12):955-962. doi: 10.1097/EJA.0000000000001106.
PubMed 31644512
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Controlled Trial of the LMA Supreme™ Versus the Spritztube® Tracheal Cannula in Anesthetized Adult Patients
- ClinicalTrials.gov ID
- NCT03443219
- Acronym / sponsor ID
- 29/16
- Conditions
- Airway Management
- Keywords
- Airway Management, Extraglottic airway device, Laryngeal mask airway, Spritztube
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- St. Bortolo HospitalUniversity, hospital or other
- Study start
- 15 Sep 2016 (actual)
- Primary completion
- 10 Jul 2017 (actual)
- Study completion
- 20 Oct 2017 (actual)
- First posted
- 23 Feb 2018 (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 study compares the LMA Supreme™ versus the Spritztube® tracheal cannula in anesthetized adult patients.
The current randomized study is designed to assess the success placement of blind insertion using LMA Supreme™ , in comparison with the Spritztube® tracheal cannula.
In addition, time, number of attempts, easy insertion and the number of complications at insertion and removal will be assessed.
The investigators hypothesize that the LMA Supreme™ versus the Spritztube® tracheal cannula will similarly perform during anesthetized adult patients despite differences in their structural design.
Detailed description
A new extraglottic airway device, the Spritztube® [tracheal cannula, Med Europe s.r.l], was developed combining the ability to perform both EAD ventilation and oro-tracheal fibreoptic intubation using the same device. The Spritztube® consists of a silicone cannula with two low-pressure cuffs: a proximal cuff, designed to seal the pharynx cranially of the epiglottis and a distal cuff, designed to seal the oesophagus. The positioning of this device requires the aid of a spindle, that keep the cuffs on the same line and it is rigid enough to allow the passage through oropharynx tissue. That can be inserted blindly as extraglottic device or through the use of direct laryngoscopy or fibroscopy as tracheal cannula.
The current randomized study is designed to assess the success placement of blind insertion using LMA Supreme™ , in comparison with the Spritztube® tracheal cannula.
In addition, time, number of attempts, easy insertion and the number of complications at insertion and removal will be assessed.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spritztube® | Experimental | Device: Spritztube®The patients were randomly allocated to two groups by using computer-generated numbers.In Spritztube® group, Spritztube® was inserted into each patient after anesthesia induction. |
| LMA Supreme™ | Active comparator | Device: LMA Supreme™The patients were randomly allocated to two groups by using computer-generated numbers.In vgroup, LMA Supreme™was inserted into each patient after anesthesia induction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anaesthesiologists (ASA) physical status classification I, II, and III;
- Age > 18 years
- Elective surgery in the supine position
Key exclusion criteria (6 listed)
- Pregnancy
- Age <18 years
- Not eligibility for surgery
- Predicted difficult airway management
- Positive history for esophageal or pharyngeal diseases
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 |
|---|---|---|
| Spritztube®After preoxygenation, anaesthesia was induced with midazolam, propofol, and fentanyl,Spritztube® was inserted and both cuffs inflated | Device | Spritztube® |
| LMA Supreme™After preoxygenation, anaesthesia was induced with midazolam, propofol, and fentanyl,LMA Supreme™ was inserted and both cuffs inflated | Device | LMA Supreme™ |
Primary outcome
the successful placement of device in two groups
Time frame: Intraoperative
A successful intubation attempt was recognized if the breathing circuit was connected, the breath sounds over the lung were present and the End tidal CO2 trace was revealed.
5 secondary outcomes
Insertion time (in seconds)
Time frame: Intraoperative
Number of attempts
Time frame: Intraoperative
Easy to insert
Time frame: Intraoperative
number of complications at insertion
Time frame: Intraoperative
number of complications at removal
Time frame: Postoperative
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 23 Feb 2018.
- Derived from this study: PubMed 31644512De Rosa S, Messina A, Sorbello M, Rigobello A, Colombo D, Piccolo A, Bonaldi E, Gennaro P, Urukalo V, Pellizzari A, Bonato R, Carboni SC. Laryngeal Mask Airway Supreme vs. the Spritztube tracheal cannula in anaesthetised adult patients: A randomised controlled trial. Eur J Anaesthesiol. 2019 Dec;36(12):955-962. doi: 10.1097/EJA.0000000000001106.
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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.
Raffaele Bonato, MD study director
Department of Anesthesiology and Intensive Care, San Bortolo Hospital, Vicenza, Italy
Questions about this trial
What is this clinical trial studying?
A study testing Spritztube® and LMA Supreme™ in people with Airway Management, run by St. Bortolo Hospital.
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: finished, as of the sponsor's last update on 23 Feb 2018. 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?
the successful placement of device in two groups (time frame: Intraoperative). 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 NCT03443219, which also lists 1 linked publication.
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 23 Feb 2018.