Conditions Requiring Sinonasal SurgeryNCT02311153
Safety and Efficacy of Laryngeal Mask Airways in Sinonasal Surgery
A study testing Mallinckrodt Endotracheal Tube (ETT) and Laryseal Laryngeal mask airway (LMA) in people with Conditions Requiring Sinonasal Surgery, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Laryngeal mask airways (LMA) have been shown to be a safe mode of airway management when delivering general anesthesia to patients during a variety of operative procedures. LMA's have been studied in a wide range of otolaryngologic procedures, and are generally safe and accepted by both anesthesia providers and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conditions Requiring Sinonasal Surgery
- What is being tested?
- Mallinckrodt Endotracheal Tube (ETT) and Laryseal Laryngeal mask airway (LMA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult patients (18 yo or older) undergoing elective sinonasal procedures including rhinoplasty, septoplasty, and paranasal sinus surgery estimated blood loss will be less than 300cc and the length of the procedure will be expected to last 2 hours or less
- American Society of Anesthesiologists (ASA) scores 1-3
- Mallampati classification 1-3
Who cannot join
- Currently pregnant
- History of obstructive sleep apnea with history of difficulty with ventilation
- Mouth opening less than 3cm
- Indications for fiberoptic intubation present
- Upper aerodigestive tract mass or malignancy
- Procedure deemed emergent
- Severe gastroesophageal reflux, severe cardiac, pulmonary, renal or hepatic co-morbidities
- Unable to consent to study
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Laryngeal mask airways (LMA) have been shown to be a safe mode of airway management when delivering general anesthesia to patients during a variety of operative procedures. LMA's have been studied in a wide range of otolaryngologic procedures, and are generally safe and accepted by both anesthesia providers and surgeons alike. This study will aim to demonstrate the safety and efficacy of LMA for airway management during sinonasal surgery by directly comparing them to endotracheal intubation in a prospective randomized single-blind study.
Read the detailed description
LMA's have been studied in a wide range of otolaryngologic procedures, and are generally safe and accepted by both anesthesia providers and surgeons alike, as a safe mode of airway management when delivering general anesthesia. In sinonasal surgery, however, there are more concerns regarding the use of LMA's for airway management. Due to the nature of sinonasal procedures, the patient is exposed to blood and secretions that may drip/flow from the nasal cavity into the oropharynx and potentially into the upper and lower airways if not protected adequately. Additionally, often times, manipulation of the patient's head throughout the procedure is encountered to improve operative positioning. As a result, both surgeons and anesthesiologists have been hesitant to utilize LMA's in these types of surgeries despite documented benefits of increased patient comfort, fewer hemodynamic fluctuations during induction of anesthesia, and better controlled emergence when using LMA's.
Specific Aims The overall purpose of this study is to demonstrate the ability to provide safe and effective ventilation and airway protection with a laryngeal mask airway (LMA) during sinonasal surgery, by directly comparing them to endotracheal intubation in a prospective randomized single-blind study.
Aim 1: Analyze and compare the incidence and severity of airway contamination/aspiration of blood and secretions during sinonasal surgery and reveal any statistically significant difference between LMA and endotracheal intubation.
Aim 2: Analyze and compare the incidence of various outcome measures including laryngospasm, bronchospasm, anesthesia time, recovery time, post-op pain medication requirements, and airway complications between LMA and endotracheal intubation.
Aim 3: Analyze and compare both patient comfort and surgeon satisfaction after procedure between LMA and endotracheal intubation groups.
- Conditions
- Conditions Requiring Sinonasal Surgery
- Being tested
- Mallinckrodt Endotracheal Tube (ETT), Laryseal Laryngeal mask airway (LMA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mallinckrodt Endotracheal Tube (ETT)Device
Patient is intubated for airway protection and ventilation with the Mallinckrodt ETT.
Laryseal Laryngeal mask airway (LMA)Device
Laryseal Laryngeal mask airway is used to provide airway protection and ventilation.
| Study group | Role | What they receive |
|---|---|---|
| Endotracheal intubation | Active comparator | Endotracheal intubation for airway management and ventilation during sinonasal surgical procedure Receives: Device: Mallinckrodt Endotracheal Tube (ETT) |
| Laryngeal mask airway | Experimental | Laryngeal mask for airway management and ventilation during sinonasal surgical procedure Receives: Device: Laryseal Laryngeal mask airway (LMA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Presence or Absence of Blood/Secretions in Trachea and Larynx Based on Soiling Score
Presence or absence of blood/secretions as noted in trachea and larynx. Patients were evaluated based on a soiling score completed by the surgeon, ranging from 0 (no contamination or soilage) to 3 (contamination of the tube/bloody secretions).
Measured: intraoperative, within about 1 hour
Secondary outcomes (5)
Anesthesia Time in Minutes
Start and stop time of anesthesia as recorded in anesthesia record
Measured: beginning and end of anesthesia (approximately 2 hours)
Recovery Time in Minutes
Minutes spent in recovery room as recorded in the recovery room record
Measured: time spent in recovery room after surgery (approximately 4 hours)
Presence of Laryngeal Spasm
As recorded in anesthesia care record
Measured: From start of anesthesia through hospital discharge (approximately 6 hours)
Post-op Pain Med Requirements
Recording pain medications given to patient as noted in the recovery room records and medication administration record
Measured: 48 hour medicine requirement
Presence or Absence of Airway Complications
Measured: Start of surgery through hospital discharge (approximately 6 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study start25 Nov 2014
- Primary completion26 Jul 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Conditions Requiring Sinonasal SurgeryStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Turner, Vanderbilt University Medical Center
- Investigators
- Justin Turner, MD, PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02311153
- Sponsor's protocol ID
- 141421
- Status last verified
- May 2018
- First submitted
- 10 Nov 2014
- Last updated
- 1 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Laryngeal Mask Airways in Sinonasal Surgery
- ClinicalTrials.gov ID
- NCT02311153
- Acronym / sponsor ID
- 141421
- Conditions
- Conditions Requiring Sinonasal Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 25 Nov 2014 (actual)
- Primary completion
- 26 Jul 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 8 Dec 2014 (estimated)
- Results
- Posted 1 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Laryngeal mask airways (LMA) have been shown to be a safe mode of airway management when delivering general anesthesia to patients during a variety of operative procedures. LMA's have been studied in a wide range of otolaryngologic procedures, and are generally safe and accepted by both anesthesia providers and surgeons alike. This study will aim to demonstrate the safety and efficacy of LMA for airway management during sinonasal surgery by directly comparing them to endotracheal intubation in a prospective randomized single-blind study.
Detailed description
LMA's have been studied in a wide range of otolaryngologic procedures, and are generally safe and accepted by both anesthesia providers and surgeons alike, as a safe mode of airway management when delivering general anesthesia. In sinonasal surgery, however, there are more concerns regarding the use of LMA's for airway management. Due to the nature of sinonasal procedures, the patient is exposed to blood and secretions that may drip/flow from the nasal cavity into the oropharynx and potentially into the upper and lower airways if not protected adequately. Additionally, often times, manipulation of the patient's head throughout the procedure is encountered to improve operative positioning. As a result, both surgeons and anesthesiologists have been hesitant to utilize LMA's in these types of surgeries despite documented benefits of increased patient comfort, fewer hemodynamic fluctuations during induction of anesthesia, and better controlled emergence when using LMA's.
Specific Aims The overall purpose of this study is to demonstrate the ability to provide safe and effective ventilation and airway protection with a laryngeal mask airway (LMA) during sinonasal surgery, by directly comparing them to endotracheal intubation in a prospective randomized single-blind study.
Aim 1: Analyze and compare the incidence and severity of airway contamination/aspiration of blood and secretions during sinonasal surgery and reveal any statistically significant difference between LMA and endotracheal intubation.
Aim 2: Analyze and compare the incidence of various outcome measures including laryngospasm, bronchospasm, anesthesia time, recovery time, post-op pain medication requirements, and airway complications between LMA and endotracheal intubation.
Aim 3: Analyze and compare both patient comfort and surgeon satisfaction after procedure between LMA and endotracheal intubation groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endotracheal intubation | Active comparator | Device: Mallinckrodt Endotracheal Tube (ETT)Endotracheal intubation for airway management and ventilation during sinonasal surgical procedure |
| Laryngeal mask airway | Experimental | Device: Laryseal Laryngeal mask airway (LMA)Laryngeal mask for airway management and ventilation during sinonasal surgical procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (18 yo or older) undergoing elective sinonasal procedures including rhinoplasty, septoplasty, and paranasal sinus surgery estimated blood loss will be less than 300cc and the length of the procedure will be expected to last 2 hours or less
- American Society of Anesthesiologists (ASA) scores 1-3
- Mallampati classification 1-3
Key exclusion criteria (8 listed)
- Currently pregnant
- History of obstructive sleep apnea with history of difficulty with ventilation
- Mouth opening less than 3cm
- Indications for fiberoptic intubation present
- Upper aerodigestive tract mass or malignancy
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 |
|---|---|---|
| Mallinckrodt Endotracheal Tube (ETT)Patient is intubated for airway protection and ventilation with the Mallinckrodt ETT. | Device | Endotracheal intubation |
| Laryseal Laryngeal mask airway (LMA)Laryseal Laryngeal mask airway is used to provide airway protection and ventilation. | Device | Laryngeal mask airway |
Primary outcome
Number of Participants With Presence or Absence of Blood/Secretions in Trachea and Larynx Based on Soiling Score
Time frame: intraoperative, within about 1 hour
Presence or absence of blood/secretions as noted in trachea and larynx. Patients were evaluated based on a soiling score completed by the surgeon, ranging from 0 (no contamination or soilage) to 3 (contamination of the tube/bloody secretions).
5 secondary outcomes
Anesthesia Time in Minutes
Time frame: beginning and end of anesthesia (approximately 2 hours)
Recovery Time in Minutes
Time frame: time spent in recovery room after surgery (approximately 4 hours)
Presence of Laryngeal Spasm
Time frame: From start of anesthesia through hospital discharge (approximately 6 hours)
Post-op Pain Med Requirements
Time frame: 48 hour medicine requirement
Presence or Absence of Airway Complications
Time frame: Start of surgery through hospital discharge (approximately 6 hours)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Justin Turner, MD, PhD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mallinckrodt Endotracheal Tube (ETT) and Laryseal Laryngeal mask airway (LMA) in people with Conditions Requiring Sinonasal Surgery, run by Vanderbilt University Medical Center at 1 site in United States.
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 8 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 1 Jun 2018. 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 United States. 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?
Yes. Results are posted in the registry (first posted 1 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Presence or Absence of Blood/Secretions in Trachea and Larynx Based on Soiling Score (time frame: intraoperative, within about 1 hour). 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 1 Jun 2018.