Laryngeal Mask AirwayNCT04769791
Three Inflation Methods of the Ambú Auraonce™ and Its Adverse Effects
A study testing intracuff pressure measurement in people with Laryngeal Mask Airway, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
Laryngeal mask airway device (LMA) is a common device used in the daily practice for airway management. Consecutive generations have permitted an expansion of its use, probably because of a rapid increase of ambulatory surgical procedures and also due to the development of procedures in areas away from the operating… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Laryngeal Mask Airway
- What is being tested?
- intracuff pressure measurement
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteSpain
- Study dates
- 17 Jul 2017to 21 Nov 2018
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients age between 18 and 90 years
- American Society of Anesthesiologists (ASA) physical status I-III
- fiberoptic bronchoscopy procedure and EBUS-TBNA procedure programmed.
- Fasted for 6 hours before procedure.
- Management of the airway for the same anesthetic.
- Use de laryngeal mask airway for boarding and maintenance of airway permeability
Who cannot join
- LMA is contraindicated because high risk of aspiration (full stomach, gastroesophageal reflux history, pregnant)
- predictors of difficult airway such restricted mouth opening (< 3 cm of interincisal distance)
- patients with any pathology of the neck, upper respiratory or upper alimentary tract
- BMI > 40 Kilogram / m2
- dysphagia o hoarseness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Three Inflation Methods of the Laryngeal Mask Airway Ambú Auraonce™ and Its Pharyngolaryngeal Adverse Effects
Laryngeal mask airway device (LMA) is a common device used in the daily practice for airway management. Consecutive generations have permitted an expansion of its use, probably because of a rapid increase of ambulatory surgical procedures and also due to the development of procedures in areas away from the operating room.
The cuff inflating volume is not standardized and it is common practice to inflate the LMA cuff according to the manufacturer's recommendations, without using a manometer.
Read more
A hyperinflation of the LMA cuff was associated with complications ranging from sore throat, or dysphagia and dysphonia, to more serious complications such as paralysis of the vocal cord, arytenoid cartilages dislocation, recurrent laryngeal nerve injury and hypoglossal nerve injury. Also, the excess of volume or pressure is related to poor ventilation and increase the risk of gastric insufflation.
The aim of this study is to evaluate the best cuff inflation method, in order to limit the intracuff pressure beyond the recommended maximum pressure (PM < 60 cmH2O) and to allows decrease the pharyngo-laryngeal complications.
The Primary outcome is to compare three different cuff inflating methods using AuraOnce™ LMA during fibrobronchoscopy and endobronchial ultrasound (EBUS) procedures, and to control the intracuff pressure, and the effect on pharyngo-laryngeal complications.
The three different cuff inflating methods are: 1) residual volume group (RV group) 2) half of the maximum volume group (MV group) 3) unchanged volume group (NVgroup)
Read the detailed description
This is a prospective randomized controlled trial. The study was approved by the Ethics Committee of University Hospital of La Paz, Madrid. Written informed consent will be obtained from each patient before the procedure. We plan to include 210 patients scheduled for a fibrobronchoscopy with EBUS-transbronchial needle aspiration (TBNA) procedures under general anesthesia using a LMA. Patients will be allocated randomly to one of three groups of cuff inflating methods according to computer-generated randomization. The size of LMA will be chosen according to body weight, following the manufacturer recommendations (LMA size 3 for patients of 30-50 kg, LMA size 4 for patients of 50-70 kg and LMA size 5 for patients with a weight >70 kg). After standard monitoring with electrocardiography, noninvasive blood pressure device and pulse oximeter were applied, general anesthesia will be induced with Propofol 2.5 mg.kg-1 and fentanyl 1 mcg.kg-1 intravenously Face mask ventilation with 100% oxygen will be used after patients have lost eyelash reflex. Then, the assigned LMA will be inserted, after appropriate conditions for insertion are obtained. LMA Insertion will be performed with standard maneuver according to LMA practice manual by the same experienced anesthesiologist (> 1-year use experience). The initial position of LMA will be assessed by visualization of bilateral chest movement when positive pressure ventilation will be performed and the square capnography waveform is observed on the monitor screen.
If the LMA is not in the proper position at the first attempt, we will use an "up and down" maneuver to adjust and reposition LMA to attain satisfactory ventilation. If this maneuver fails, LMA will be withdrawn from the mouth of the patients and a second attempt will be authorized to acquire a correct position. If the proper position of LMA cannot be achieved after two attempts, the airway will be controlled with another device or a tracheal intubation will be performed and the patients will be excluded from the trial.
The patient´s lungs will be ventilated with the anesthesia machine in controlled volume mode, using the following parameters: Tidal volume, 8 ml/kg; frequency, 12-14 per min; the ratio of inspiratory and expiratory, (I: E) = 1:2; and positive end expiratory pressure, 5 cmH20.
After the LMA will be fixed with adhesive tape and the vital signs will be stable, the LMA cuff will be connected with a closed system manometer composed of a three-way stopcock, a 5 ml syringe and a manometer. Intracuff pressure will be measured and recorded, if it exceeds of 60 cmH20 we will deflate the cuff 1 mL by 1 mL with the syringe until intracuff pressure reaches 60 cmH20. The deflated volume and the final intracuff pressure will be recorded. We will measure the inspiratory peak airway pressure, the volume difference of inspiratory and expiratory tidal volume under the positive pressure ventilation. The plateau pressure, medium pressure and Compliance will also be recorded at the corresponding cuff inflating volume, before and after measuring OLP. The OLP will be measured simultaneously at the corresponding cuff inflating volume, by setting the airway pressure relief valve (APL) of the breathing circuit to 40 cmH20 at a fixed gas flow rate of 4 L/ min and reading the airway pressure on manometer at which equilibrium of airway pressure will be established or at the pressure the air leakage will be heard.
Fiberoptic visibility scores will be recorded on a scale of 1 to 4 (4: only vocal cords visible, 3: vocal cords plus posterior epiglottis visible, 2: vocal cords plus anterior epiglottis visible, 1: vocal cords not seen). A score of 1 will be considered the worst and a score of 4 was considered the best.
Any adverse events (i.e., desaturation (pulse oximetry< 90%), aspiration/regurgitation, bronchospasm, airway obstruction, coughing, gagging or vomiting) and corresponding interventions will be recorded.
After the procedure, all patients will be transferred to the recovery unit and observed for at least 1 hour. Observed adverse effects, such as sore throat, hoarseness, aphasia, nausea and vomiting will be recorded in the recovery room period.
At 24h, a home telephone interview will record these parameters, as well as patient satisfaction scores using visual analog scales.
- Conditions
- Laryngeal Mask Airway
- Being tested
- intracuff pressure measurement
- Keywords
- laryngeal mask, intracuff pressure, sore throat
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intracuff pressure measurementDevice
intracuff pressure is measured by a pressure manometer
intracuff pressure measurementDevice
intracuff pressure is measured by a pressure manometer
intracuff pressure measurementDevice
intracuff pressure is measured by a pressure manometer
| Study group | Role | What they receive |
|---|---|---|
| cuff inflation by the residual volume | Experimental | LMA will be inserted with the initial inflating volume correspondent to residual volume group ( RV group): volume result of equilibrating pressure between intracuff pressure and atmospheric pressure. A 20 ml syringe without plunger is connected to the laryngeal cuff for 5 minutes. Receives: Device: intracuff pressure measurement |
| cuff inflation by half of the maximum volume | Experimental | LMA will be inserted with the initial inflating volume correspondent to half of the maximum volume recommended by manufacturers (MV group): Receives: Device: intracuff pressure measurement |
| unchanged cuff inflation volume | Experimental | LMA will be inserted with the initial inflating volume correspondent to unchanged volume group (NV group): LMA is unpacked and used without inflating or deflating the cuff. Receives: Device: intracuff pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracuff Pressure
Compare Intracuff Pressure of three different cuff inflating volume methods with laryngeal mask, to control the intracuff pressure
Measured: procedure ( after correct placement of SGD)
Secondary outcomes (5)
time of insertion
Compare time of insertion in the three different cuff inflating volume methods
Measured: procedure ( from pick up to correct placement of SGD
insertion attempts
Compare insertion attempts in the three different cuff inflating volume methods
Measured: procedure ( from pick up to correct placement of SGD
OLP
We measure the oropharyngeal leak pressure (OLP) as a sealing efficacy test.
Measured: procedure ( after correct placement of SGD)
positioning of the LMA
Compare the positioning of the LMA with the three methods of inflating cuff. Fiberoptic visibility scores will be recorded on a scale of 1 to 4 (4: only vocal cords visible, 3: vocal cords plus posterior epiglottis visible, 2: vocal cords plus anterior epiglottis visible, 1: vocal cords not seen). A score of 1 will be considered the worst and a score of 4 was considered the best.
Measured: procedure (after correct placement of SGD)
pharyngolaryngeal complications
Describe sore throat, dysphagia and dysphonia
Measured: day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start17 Jul 2017
- Primary completion21 Nov 2018
- Study completion21 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Laryngeal Mask AirwayStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teresa Prim, Instituto de Investigación Hospital Universitario La Paz
- Investigators
- TERESA PRIM MARTINEZ, MD, Principal investigator, HOSPITAL La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769791
- Sponsor's protocol ID
- Idipaz 4888
- Status last verified
- Feb 2021
- First submitted
- 12 Feb 2021
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Seet E, Yousaf F, Gupta S, Subramanyam R, Wong DT, Chung F. Use of manometry for laryngeal mask airway reduces postoperative pharyngolaryngeal adverse events: a prospective, randomized trial. Anesthesiology. 2010 Mar;112(3):652-7. doi: 10.1097/ALN.0b013e3181cf4346.
PubMed 20179502Ghai B, Sethi S, Ram J, Wig J. Cuff filling volumes for pediatric classic laryngeal mask airways: comparison of clinical end points versus adjusted cuff pressure. Paediatr Anaesth. 2013 Feb;23(2):122-6. doi: 10.1111/pan.12023. Epub 2012 Sep 18.
PubMed 22985184Keller C, Puhringer F, Brimacombe JR. Influence of cuff volume on oropharyngeal leak pressure and fibreoptic position with the laryngeal mask airway. Br J Anaesth. 1998 Aug;81(2):186-7. doi: 10.1093/bja/81.2.186.
PubMed 9813520Li BB, Yan J, Zhou HG, Hao J, Liu AJ, Ma ZL. Application of Minimum Effective Cuff Inflating Volume for Laryngeal Mask Airway and its Impact on Postoperative Pharyngeal Complications. Chin Med J (Engl). 2015 Oct 5;128(19):2570-6. doi: 10.4103/0366-6999.166034.
PubMed 26415792Ruananukun N, Watcharotayangul J, Jeeranukosol S, Komonhirun R. Correlation and variation of cuff inflating volumes and pressures in different adult models of laryngeal mask: a prospective randomized trial. BMC Anesthesiol. 2020 May 7;20(1):108. doi: 10.1186/s12871-020-01028-4.
PubMed 32380954Prim T, Brogly N, Guasch E, Diez J, Gilsanz F. Efficacy and safety of three inflation methods of the laryngeal mask airway Ambu(R) Auraonce: a randomized controlled study. J Clin Monit Comput. 2024 Feb;38(1):37-45. doi: 10.1007/s10877-023-01061-x. Epub 2023 Aug 4.
PubMed 37540323
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Inflation Methods of the Laryngeal Mask Airway Ambú Auraonce™ and Its Pharyngolaryngeal Adverse Effects
- ClinicalTrials.gov ID
- NCT04769791
- Acronym / sponsor ID
- Idipaz 4888
- Conditions
- Laryngeal Mask Airway
- Keywords
- laryngeal mask, intracuff pressure, sore throat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- 17 Jul 2017 (actual)
- Primary completion
- 21 Nov 2018 (actual)
- Study completion
- 21 Nov 2018 (actual)
- First posted
- 25 Feb 2021 (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.
Laryngeal mask airway device (LMA) is a common device used in the daily practice for airway management. Consecutive generations have permitted an expansion of its use, probably because of a rapid increase of ambulatory surgical procedures and also due to the development of procedures in areas away from the operating room.
The cuff inflating volume is not standardized and it is common practice to inflate the LMA cuff according to the manufacturer's recommendations, without using a manometer.
A hyperinflation of the LMA cuff was associated with complications ranging from sore throat, or dysphagia and dysphonia, to more serious complications such as paralysis of the vocal cord, arytenoid cartilages dislocation, recurrent laryngeal nerve injury and hypoglossal nerve injury. Also, the excess of volume or pressure is related to poor ventilation and increase the risk of gastric insufflation.
The aim of this study is to evaluate the best cuff inflation method, in order to limit the intracuff pressure beyond the recommended maximum pressure (PM < 60 cmH2O) and to allows decrease the pharyngo-laryngeal complications.
The Primary outcome is to compare three different cuff inflating methods using AuraOnce™ LMA during fibrobronchoscopy and endobronchial ultrasound (EBUS) procedures, and to control the intracuff pressure, and the effect on pharyngo-laryngeal complications.
The three different cuff inflating methods are: 1) residual volume group (RV group) 2) half of the maximum volume group (MV group) 3) unchanged volume group (NVgroup)
Detailed description
This is a prospective randomized controlled trial. The study was approved by the Ethics Committee of University Hospital of La Paz, Madrid. Written informed consent will be obtained from each patient before the procedure. We plan to include 210 patients scheduled for a fibrobronchoscopy with EBUS-transbronchial needle aspiration (TBNA) procedures under general anesthesia using a LMA. Patients will be allocated randomly to one of three groups of cuff inflating methods according to computer-generated randomization. The size of LMA will be chosen according to body weight, following the manufacturer recommendations (LMA size 3 for patients of 30-50 kg, LMA size 4 for patients of 50-70 kg and LMA size 5 for patients with a weight >70 kg). After standard monitoring with electrocardiography, noninvasive blood pressure device and pulse oximeter were applied, general anesthesia will be induced with Propofol 2.5 mg.kg-1 and fentanyl 1 mcg.kg-1 intravenously Face mask ventilation with 100% oxygen will be used after patients have lost eyelash reflex. Then, the assigned LMA will be inserted, after appropriate conditions for insertion are obtained. LMA Insertion will be performed with standard maneuver according to LMA practice manual by the same experienced anesthesiologist (> 1-year use experience). The initial position of LMA will be assessed by visualization of bilateral chest movement when positive pressure ventilation will be performed and the square capnography waveform is observed on the monitor screen.
If the LMA is not in the proper position at the first attempt, we will use an "up and down" maneuver to adjust and reposition LMA to attain satisfactory ventilation. If this maneuver fails, LMA will be withdrawn from the mouth of the patients and a second attempt will be authorized to acquire a correct position. If the proper position of LMA cannot be achieved after two attempts, the airway will be controlled with another device or a tracheal intubation will be performed and the patients will be excluded from the trial.
The patient´s lungs will be ventilated with the anesthesia machine in controlled volume mode, using the following parameters: Tidal volume, 8 ml/kg; frequency, 12-14 per min; the ratio of inspiratory and expiratory, (I: E) = 1:2; and positive end expiratory pressure, 5 cmH20.
After the LMA will be fixed with adhesive tape and the vital signs will be stable, the LMA cuff will be connected with a closed system manometer composed of a three-way stopcock, a 5 ml syringe and a manometer. Intracuff pressure will be measured and recorded, if it exceeds of 60 cmH20 we will deflate the cuff 1 mL by 1 mL with the syringe until intracuff pressure reaches 60 cmH20. The deflated volume and the final intracuff pressure will be recorded. We will measure the inspiratory peak airway pressure, the volume difference of inspiratory and expiratory tidal volume under the positive pressure ventilation. The plateau pressure, medium pressure and Compliance will also be recorded at the corresponding cuff inflating volume, before and after measuring OLP. The OLP will be measured simultaneously at the corresponding cuff inflating volume, by setting the airway pressure relief valve (APL) of the breathing circuit to 40 cmH20 at a fixed gas flow rate of 4 L/ min and reading the airway pressure on manometer at which equilibrium of airway pressure will be established or at the pressure the air leakage will be heard.
Fiberoptic visibility scores will be recorded on a scale of 1 to 4 (4: only vocal cords visible, 3: vocal cords plus posterior epiglottis visible, 2: vocal cords plus anterior epiglottis visible, 1: vocal cords not seen). A score of 1 will be considered the worst and a score of 4 was considered the best.
Any adverse events (i.e., desaturation (pulse oximetry< 90%), aspiration/regurgitation, bronchospasm, airway obstruction, coughing, gagging or vomiting) and corresponding interventions will be recorded.
After the procedure, all patients will be transferred to the recovery unit and observed for at least 1 hour. Observed adverse effects, such as sore throat, hoarseness, aphasia, nausea and vomiting will be recorded in the recovery room period.
At 24h, a home telephone interview will record these parameters, as well as patient satisfaction scores using visual analog scales.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cuff inflation by the residual volume | Experimental | Device: intracuff pressure measurementLMA will be inserted with the initial inflating volume correspondent to residual volume group ( RV group): volume result of equilibrating pressure between intracuff pressure and atmospheric pressure. A 20 ml syringe without plunger is connected to the laryngeal cuff for 5 minutes. |
| cuff inflation by half of the maximum volume | Experimental | Device: intracuff pressure measurementLMA will be inserted with the initial inflating volume correspondent to half of the maximum volume recommended by manufacturers (MV group): |
| unchanged cuff inflation volume | Experimental | Device: intracuff pressure measurementLMA will be inserted with the initial inflating volume correspondent to unchanged volume group (NV group): LMA is unpacked and used without inflating or deflating the cuff. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients age between 18 and 90 years
- American Society of Anesthesiologists (ASA) physical status I-III
- fiberoptic bronchoscopy procedure and EBUS-TBNA procedure programmed.
- Fasted for 6 hours before procedure.
- Management of the airway for the same anesthetic.
Key exclusion criteria (5 listed)
- LMA is contraindicated because high risk of aspiration (full stomach, gastroesophageal reflux history, pregnant)
- predictors of difficult airway such restricted mouth opening (< 3 cm of interincisal distance)
- patients with any pathology of the neck, upper respiratory or upper alimentary tract
- BMI > 40 Kilogram / m2
- dysphagia o hoarseness
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 |
|---|---|---|
| intracuff pressure measurementintracuff pressure is measured by a pressure manometer | Device | cuff inflation by the residual volume |
| intracuff pressure measurementintracuff pressure is measured by a pressure manometer | Device | cuff inflation by half of the maximum volume |
| intracuff pressure measurementintracuff pressure is measured by a pressure manometer | Device | unchanged cuff inflation volume |
Primary outcome
Intracuff Pressure
Time frame: procedure ( after correct placement of SGD)
Compare Intracuff Pressure of three different cuff inflating volume methods with laryngeal mask, to control the intracuff pressure
5 secondary outcomes
time of insertion
Time frame: procedure ( from pick up to correct placement of SGD
insertion attempts
Time frame: procedure ( from pick up to correct placement of SGD
OLP
Time frame: procedure ( after correct placement of SGD)
positioning of the LMA
Time frame: procedure (after correct placement of SGD)
pharyngolaryngeal complications
Time frame: day 2
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 26 Feb 2021.
- Background: PubMed 20179502Seet E, Yousaf F, Gupta S, Subramanyam R, Wong DT, Chung F. Use of manometry for laryngeal mask airway reduces postoperative pharyngolaryngeal adverse events: a prospective, randomized trial. Anesthesiology. 2010 Mar;112(3):652-7. doi: 10.1097/ALN.0b013e3181cf4346.
- Background: PubMed 22985184Ghai B, Sethi S, Ram J, Wig J. Cuff filling volumes for pediatric classic laryngeal mask airways: comparison of clinical end points versus adjusted cuff pressure. Paediatr Anaesth. 2013 Feb;23(2):122-6. doi: 10.1111/pan.12023. Epub 2012 Sep 18.
- Background: PubMed 9813520Keller C, Puhringer F, Brimacombe JR. Influence of cuff volume on oropharyngeal leak pressure and fibreoptic position with the laryngeal mask airway. Br J Anaesth. 1998 Aug;81(2):186-7. doi: 10.1093/bja/81.2.186.
- Background: PubMed 26415792Li BB, Yan J, Zhou HG, Hao J, Liu AJ, Ma ZL. Application of Minimum Effective Cuff Inflating Volume for Laryngeal Mask Airway and its Impact on Postoperative Pharyngeal Complications. Chin Med J (Engl). 2015 Oct 5;128(19):2570-6. doi: 10.4103/0366-6999.166034.
- Background: PubMed 32380954Ruananukun N, Watcharotayangul J, Jeeranukosol S, Komonhirun R. Correlation and variation of cuff inflating volumes and pressures in different adult models of laryngeal mask: a prospective randomized trial. BMC Anesthesiol. 2020 May 7;20(1):108. doi: 10.1186/s12871-020-01028-4.
- Derived from this study: PubMed 37540323Prim T, Brogly N, Guasch E, Diez J, Gilsanz F. Efficacy and safety of three inflation methods of the laryngeal mask airway Ambu(R) Auraonce: a randomized controlled study. J Clin Monit Comput. 2024 Feb;38(1):37-45. doi: 10.1007/s10877-023-01061-x. Epub 2023 Aug 4.
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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.
TERESA PRIM MARTINEZ, MD principal investigator
HOSPITAL La Paz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intracuff pressure measurement in people with Laryngeal Mask Airway, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
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 6 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 26 Feb 2021. 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 Spain. 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?
Intracuff Pressure (time frame: procedure ( after correct placement of SGD)). 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 NCT04769791, which also lists 6 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 26 Feb 2021.