Respiratory Distress Syndrome, NewbornNCT06606444
Feasibility Study of Placement and Surfactant Administration Through a Preterm Size Laryngeal Mask Airway in Very Low Birth Weight Neonates With Respiratory Distress Syndrome
A study testing Surfactant Administration Through Laryngeal or Supraglottic Airways in people with Respiratory Distress Syndrome, Newborn, run by Karolinska Institutet at 1 site in Vietnam.
Trial summary
Surfactant administration via a supraglottic airway device or laryngeal mask airway (SALSA) is a minimally invasive method of instilling surfactant in the trachea during spontaneous breathing and after applying nasal continuous positive airway pressure (nCPAP). Read more about this study
- Who is it for?
- Ages Up to 48 hours
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn
- What is being tested?
- Surfactant Administration Through Laryngeal or Supraglottic Airways
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteVietnam
- Study dates
- 20 Sep 2024to 1 Aug 2025
- 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 Up to 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parental informed consent, AND
- Inborn neonate (=born in the hospital), AND
- Gestational age less than 34 + 0 weeks, AND
- Age less than 48 hours, AND
- Birth weight from 750g to 1500g, AND
- Clinical diagnosis of RDS requiring non-invasive respiratory support (CPAP/NIPPV) and fraction of inspired oxygen (FiO2) 0.30-0.60 to maintain oxygen saturation (SpO2) between 90% and 95%.
Who cannot join
- Severe respiratory insufficiency in need of emergency intubation
- Previous surfactant administration
- Previous mechanical ventilation
- Known pneumothorax
- Major malformations
- Investigators not available
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Phu San Hanoi Hospital - Hanoi Obstetrics and Gynecology Hospital
Hanoi, 118000
About this study
Official title: A Single-arm, Prospective Feasibility Study of Placement and Surfactant Administration Through a Preterm Size Laryngeal Mask Airway in Very Low Birth Weight Neonates, With Respiratory Distress Syndrome, at a Level III Neonatal Intensive Care Unit in Hanoi, Vietnam
Surfactant administration via a supraglottic airway device or laryngeal mask airway (SALSA) is a minimally invasive method of instilling surfactant in the trachea during spontaneous breathing and after applying nasal continuous positive airway pressure (nCPAP). However, the procedure has been limited from use in very low birth weight neonates, due to lack of preterm size LMAs, which are now emerging on the market.
The goal of this study is to see if investigators can successfully use a new, smaller laryngeal mask airway (LMA) to place and give surfactant to premature babies with respiratory distress syndrome (RDS) who weigh between 750g and 1500g at birth.
Read more
The main objectives of the study are to:
- Check the placement of the new, smaller LMA: This includes evaluating the airway, how long it takes to place the LMA, how many attempts are needed, and the baby's stability during the process.
- Evaluate the administration of surfactant using the new LMA: Investigators will look at how the baby responds clinically, any changes in oxygen needs, how many doses of surfactant are required, the level of respiratory support needed, and whether intubation or mechanical ventilation is necessary.
- Ensure the safety of using the new LMA and administering surfactant: Investigators will monitor the baby's stability during the procedure and watch for any adverse events.
- Assess pain during the procedure: Investigators will evaluate pain levels using a pain scale based on video reviews.
Above objectives of feasibility are to be assessed before proceeding to a large randomize clinical trial assessing effectiveness and safety.
Read the detailed description
Methodology Feasibility will be measure by a combination of real-life observations of the procedure and video-review with synced physiological data (oxygen saturation and heart rate).
Study Site The Phu San Hanoi Hospital, the largest obstetric hospital in northern Vietnam, receives about 40.000 births annually and has a level-III neonatal intensive care unit with capacity of approximately 40 neonates. Approximately 10-15 neonates weighing less than 1500g per month are admitted who receives standard surfactant treatment with IN-tubation-SURfactant-Extubation (INSURE).
- Conditions
- Respiratory Distress Syndrome, Newborn
- Being tested
- Surfactant Administration Through Laryngeal or Supraglottic Airways
- Keywords
- surfactant, laryngeal mask airway, supraglottic airway device, preterm infant, neonate, newborn, vietnam, feasibility, pilot, SALSA, RDS, respiratory distress syndrome, very low birth weight
- Medical subject headings
- Respiratory Distress Syndrome, Newborn, Premature Birth, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surfactant Administration Through Laryngeal or Supraglottic AirwaysDevice
Also called Laryngeal mask airway surfactant administration, Surfactant Therapy via Laryngeal Mask Airway, Laryngeal Mask Airway for Surfactant Administration in Neonates, Supraglottic airway devices for surfactant treatment
While the child is spontaneously breathing on nasal CPAP treatment, the neonatal intensive care (NICU) physician will place the LMA and assess for adequate airway by CO2-detection, chest movement, pulmonary auscultation of bilateral breath sounds, gastric insufflation, oxygen saturation and heart rate. A placement attempt should not last more than 30 seconds. Surfactant will be administered slowly in 1-2 ml aliquots (Curosurf 200 mg/kg) via an appropriate size laryngeal mask airway. The neonate should primarily be spontaneously breathing and if needed receives gentle supportive positive pressure ventilation (PPV). Gentle supportive PPV is given for 30 seconds after surfactant is administered, before LMA is removed.
| Study group | Role | What they receive |
|---|---|---|
| Surfactant administered via laryngeal mask airway | Experimental | Enrolled infants will receive surfactant delivered via a neonatal size laryngeal mask airway. Receives: Device: Surfactant Administration Through Laryngeal or Supraglottic Airways |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful LMA placement, with signs of adequate airway, allowing two attempts.
Categorical variable (Yes/No)
A successful placement attempt is defined as insertion of the LMA into the infant's mouth with signs of adequate airway, as per judgement of the physician performing the procedure. Factors that will be considered are carbon dioxide (CO2)-detection, chest movement, pulmonary auscultation of bilateral breath sounds, oxygen saturation and heart rate.
Measured: During procedure. 0-30 minutes.
Secondary outcomes (35)
Confirmation of carbon dioxide on carbon dioxide detector
Categorical (Yes/No)
Measured: During procedure. 0-30 minutes.
Chest rise during LMA placement
Categorical (Yes/No)
Measured: During procedure 0-30 minutes.
Bilateral breath sounds by auscultation during LMA placement
Categorical (Yes/No)
Measured: During procedure. 0-30 minutes.
Number of attempts required for successful placement
Numerical variable.
Measured: During procedure. 0-30 minutes.
Attempt duration more than 30 seconds
Categorical variable (Yes/No)
Measured: During procedure. 0-30 minutes.
Duration of each LMA placement attempt
Numerical variable (seconds)
Measured: During procedure. 0-30 minutes.
Time between attempts
Numerical variable (seconds)
Measured: During procedure. 0-30 minutes.
Fluctuations in heart rate during placement
Numerical variable (beats per minute). Difference between mean/median at baseline and during placement. Measured by pulse oximetry.
Measured: During procedure. 0-30 minutes.
Fluctuations in oxygen saturation (SpO2) during placement
Numerical variable (percentage). Difference between mean/median at baseline and during placement. Measured by pulse oximetry.
Measured: During procedure. 0-30 minutes.
Fluctuations in heart rate during surfactant administration
Numerical variable (beats per minute). Difference between mean/median at baseline and during surfactant administration. Measured by pulse oximetry.
Measured: During procedure. 0-30 minutes.
Fluctuations in oxygen saturation (SpO2) during surfactant administration
Numerical variable (percentage). Difference between mean/median at baseline and during surfactant administration Measured by pulse oximetry.
Measured: During procedure. 0-30 minutes.
Duration of SpO2 less than 80%
Numerical variable (seconds)
Measured: During procedure. 0-30 minutes.
Duration of SpO2 less than 60%
Numerical variable (seconds)
Measured: During procedure. 0-30 minutes.
Duration of SpO2 less than 40%
Numerical variable (seconds)
Measured: During procedure. 0-30 minutes.
Duration of heart rate less than 100 beats per minute (bpm)
Numerical variable (seconds)
Measured: During procedure. 0-30 minutes.
Duration of heart rate less than 60 beats per minute (bpm)
Numerical variable (seconds)
Measured: During procedure. 0-30 minutes.
Number of bradycardia less than 60 bpm for more than 10 seconds
Numerical variable.
Measured: During procedure. 0-30 minutes.
Number of desaturations to less 80% for more than 30 seconds
Numerical variable.
Measured: During procedure. 0-30 minutes.
Number of apneas lasting more than 20 seconds
Numerical variable
Measured: During procedure. 0-30 minutes.
Volume of surfactant in gastric residuals after the procedure
Numerical variable (milliliters)
Measured: During procedure. 0-30 minutes.
Total procedure duration
Numerical variable (seconds)
Measured: During procedure. 0-30 minutes.
Duration of positive pressure ventilation during LMA placement
Numerical variable (seconds)
Measured: During procedure. 0-30 minutes.
Duration of positive pressure ventilation during surfactant administration
Numerical variable (seconds)
Measured: During procedure. 0-30 minutes.
Duration of positive pressure ventilation during procedure
Numerical variable (seconds)
Measured: During procedure. 0-30 minutes.
Fraction of inspired oxygen
Oxygen requirement to maintain SpO2 between 90-95%. Measured before start of procedure and at 5 minutes , 15 minutes , 30 minutes and 1 hour post-procedure.
Measured: 10 minutes before procedure until 1 hour after procedure.
Need for early redosing of surfactant
Categorical (Yes/No)
Measured: Within 6 hours from first surfactant administration
Need for invasive mechanical ventilation within 72 hours
Categorical (Yes/No)
Measured: Within 72 hours after surfactant administration
Death
Categorical (Yes/No)
Measured: Within 7 days after birth
Duration of oxygen requirement after surfactant administration
Numerical (hours)
Measured: Within 7 days after birth
Duration of continuous positive airway pressure (CPAP) after surfactant administration
Numerical variable (hours)
Measured: Within 7 days after birth
Duration of non-invasive positive pressure ventilation (NIPPV) after surfactant administration
Numerical variable (hours)
Measured: Within 7 days after birth
Duration of invasive mechanical ventilation after surfactant administration
Numerical variable (hours)
Measured: Within 7 days after birth
Number of surfactant doses given
Numerical variable
Measured: Within 7 days after birth
Need for subsequent intubation and mechanical ventilation
Categorical variable (Yes/No)
Measured: Within 7 days after birth
Administration method for subsequent surfactant doses
Categorical. (Surfactant via laryngeal mask airway OR Surfactant via Intubation-Surfactant-Extubation OR Surfactant via intubation followed by mechanical ventilation)
Measured: Within 7 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start20 Sep 2024
- Primary completion13 Jul 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, NewbornStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Hanoi Medical University, Hanoi Obstetrics and Gynecology Hospital, Göteborg University
- Responsible party
- Principal investigator, Tobias Alfvén, Karolinska Institutet
- Investigators
- Tobias Alfvén, Professor, M.D, Ph.D, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606444
- Sponsor's protocol ID
- 2090 CN/PS
- Other IDs
- 2018-02770, 2018
- Status last verified
- Aug 2025
- First submitted
- 9 Sep 2024
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and/or analysed during the current study will be available from the principal investigator on reasonable request after publication of results.
Publications
Abdel-Latif ME, Walker E, Osborn DA. Laryngeal mask airway surfactant administration for prevention of morbidity and mortality in preterm infants with or at risk of respiratory distress syndrome. Cochrane Database Syst Rev. 2024 Jan 25;1(1):CD008309. doi: 10.1002/14651858.CD008309.pub3.
PubMed 38270182Larsson M, Vu H, Nguyen LT, Nguyen HL, Nguyen HT, Tran NL, Nguyen H, Thi Pham PT, Nguyen TK, Elfvin A, Drevhammar T, Mai HT, Myrnerts Hook S, Alfven T, Pejovic NJ. Feasibility of Surfactant Delivery via Preterm Supraglottic Airways in Infants with Birth Weights of 800-1500 g. J Pediatr. 2026 Aug 4;299:115269. doi: 10.1016/j.jpeds.2026.115269. Online ahead of print.
PubMed 42551730
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Prospective Feasibility Study of Placement and Surfactant Administration Through a Preterm Size Laryngeal Mask Airway in Very Low Birth Weight Neonates, With Respiratory Distress Syndrome, at a Level III Neonatal Intensive Care Unit in Hanoi, Vietnam
- ClinicalTrials.gov ID
- NCT06606444
- Acronym / sponsor ID
- 2090 CN/PS
- Conditions
- Respiratory Distress Syndrome, Newborn
- Keywords
- surfactant, laryngeal mask airway, supraglottic airway device, preterm infant, neonate, newborn, vietnam, feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Hanoi Medical University, Hanoi Obstetrics and Gynecology Hospital, Göteborg University
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 13 Jul 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 23 Sep 2024 (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.
Surfactant administration via a supraglottic airway device or laryngeal mask airway (SALSA) is a minimally invasive method of instilling surfactant in the trachea during spontaneous breathing and after applying nasal continuous positive airway pressure (nCPAP). However, the procedure has been limited from use in very low birth weight neonates, due to lack of preterm size LMAs, which are now emerging on the market.
The goal of this study is to see if investigators can successfully use a new, smaller laryngeal mask airway (LMA) to place and give surfactant to premature babies with respiratory distress syndrome (RDS) who weigh between 750g and 1500g at birth.
The main objectives of the study are to:
- Check the placement of the new, smaller LMA: This includes evaluating the airway, how long it takes to place the LMA, how many attempts are needed, and the baby's stability during the process.
- Evaluate the administration of surfactant using the new LMA: Investigators will look at how the baby responds clinically, any changes in oxygen needs, how many doses of surfactant are required, the level of respiratory support needed, and whether intubation or mechanical ventilation is necessary.
- Ensure the safety of using the new LMA and administering surfactant: Investigators will monitor the baby's stability during the procedure and watch for any adverse events.
- Assess pain during the procedure: Investigators will evaluate pain levels using a pain scale based on video reviews.
Above objectives of feasibility are to be assessed before proceeding to a large randomize clinical trial assessing effectiveness and safety.
Detailed description
Methodology Feasibility will be measure by a combination of real-life observations of the procedure and video-review with synced physiological data (oxygen saturation and heart rate).
Study Site The Phu San Hanoi Hospital, the largest obstetric hospital in northern Vietnam, receives about 40.000 births annually and has a level-III neonatal intensive care unit with capacity of approximately 40 neonates. Approximately 10-15 neonates weighing less than 1500g per month are admitted who receives standard surfactant treatment with IN-tubation-SURfactant-Extubation (INSURE).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surfactant administered via laryngeal mask airway | Experimental | Device: Surfactant Administration Through Laryngeal or Supraglottic AirwaysEnrolled infants will receive surfactant delivered via a neonatal size laryngeal mask airway. |
Who may qualify
- Ages
- Up to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Parental informed consent, AND
- Inborn neonate (=born in the hospital), AND
- Gestational age less than 34 + 0 weeks, AND
- Age less than 48 hours, AND
- Birth weight from 750g to 1500g, AND
Key exclusion criteria (6 listed)
- Severe respiratory insufficiency in need of emergency intubation
- Previous surfactant administration
- Previous mechanical ventilation
- Known pneumothorax
- Major malformations
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 |
|---|---|---|
| Surfactant Administration Through Laryngeal or Supraglottic AirwaysAlso: Laryngeal mask airway surfactant administration, Surfactant Therapy via Laryngeal Mask Airway, Laryngeal Mask Airway for Surfactant Administration in Neonates, Supraglottic airway devices for surfactant treatmentWhile the child is spontaneously breathing on nasal CPAP treatment, the neonatal intensive care (NICU) physician will place the LMA and assess for adequate airway by CO2-detection, chest movement, pulmonary auscultation of bilateral breath sounds, gastric insufflation, oxygen saturation and heart rate. A placement attempt should not last more than 30 seconds. Surfactant will be administered slowly in 1-2 ml aliquots (Curosurf 200 mg/kg) via an appropriate size laryngeal mask airway. The neonate should primarily be spontaneously breathing and if needed receives gentle supportive positive pressure ventilation (PPV). Gentle supportive PPV is given for 30 seconds after surfactant is administered, before LMA is removed. | Device | Surfactant administered via laryngeal mask airway |
Primary outcome
Successful LMA placement, with signs of adequate airway, allowing two attempts.
Time frame: During procedure. 0-30 minutes.
Categorical variable (Yes/No) A successful placement attempt is defined as insertion of the LMA into the infant's mouth with signs of adequate airway, as per judgement of the physician performing the procedure. Factors that will be considered are carbon dioxide (CO2)-detection, chest movement, pulmonary auscultation of bilateral breath sounds, oxygen saturation and heart rate.
35 secondary outcomes
Confirmation of carbon dioxide on carbon dioxide detector
Time frame: During procedure. 0-30 minutes.
Chest rise during LMA placement
Time frame: During procedure 0-30 minutes.
Bilateral breath sounds by auscultation during LMA placement
Time frame: During procedure. 0-30 minutes.
Number of attempts required for successful placement
Time frame: During procedure. 0-30 minutes.
Attempt duration more than 30 seconds
Time frame: During procedure. 0-30 minutes.
Duration of each LMA placement attempt
Time frame: During procedure. 0-30 minutes.
Time between attempts
Time frame: During procedure. 0-30 minutes.
Fluctuations in heart rate during placement
Time frame: During procedure. 0-30 minutes.
Fluctuations in oxygen saturation (SpO2) during placement
Time frame: During procedure. 0-30 minutes.
Fluctuations in heart rate during surfactant administration
Time frame: During procedure. 0-30 minutes.
Fluctuations in oxygen saturation (SpO2) during surfactant administration
Time frame: During procedure. 0-30 minutes.
Duration of SpO2 less than 80%
Time frame: During procedure. 0-30 minutes.
Duration of SpO2 less than 60%
Time frame: During procedure. 0-30 minutes.
Duration of SpO2 less than 40%
Time frame: During procedure. 0-30 minutes.
Duration of heart rate less than 100 beats per minute (bpm)
Time frame: During procedure. 0-30 minutes.
Duration of heart rate less than 60 beats per minute (bpm)
Time frame: During procedure. 0-30 minutes.
Number of bradycardia less than 60 bpm for more than 10 seconds
Time frame: During procedure. 0-30 minutes.
Number of desaturations to less 80% for more than 30 seconds
Time frame: During procedure. 0-30 minutes.
Number of apneas lasting more than 20 seconds
Time frame: During procedure. 0-30 minutes.
Volume of surfactant in gastric residuals after the procedure
Time frame: During procedure. 0-30 minutes.
Total procedure duration
Time frame: During procedure. 0-30 minutes.
Duration of positive pressure ventilation during LMA placement
Time frame: During procedure. 0-30 minutes.
Duration of positive pressure ventilation during surfactant administration
Time frame: During procedure. 0-30 minutes.
Duration of positive pressure ventilation during procedure
Time frame: During procedure. 0-30 minutes.
Fraction of inspired oxygen
Time frame: 10 minutes before procedure until 1 hour after procedure.
Need for early redosing of surfactant
Time frame: Within 6 hours from first surfactant administration
Need for invasive mechanical ventilation within 72 hours
Time frame: Within 72 hours after surfactant administration
Death
Time frame: Within 7 days after birth
Duration of oxygen requirement after surfactant administration
Time frame: Within 7 days after birth
Duration of continuous positive airway pressure (CPAP) after surfactant administration
Time frame: Within 7 days after birth
Duration of non-invasive positive pressure ventilation (NIPPV) after surfactant administration
Time frame: Within 7 days after birth
Duration of invasive mechanical ventilation after surfactant administration
Time frame: Within 7 days after birth
Number of surfactant doses given
Time frame: Within 7 days after birth
Need for subsequent intubation and mechanical ventilation
Time frame: Within 7 days after birth
Administration method for subsequent surfactant doses
Time frame: Within 7 days after birth
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 19 Aug 2025.
- Background: PubMed 38270182Abdel-Latif ME, Walker E, Osborn DA. Laryngeal mask airway surfactant administration for prevention of morbidity and mortality in preterm infants with or at risk of respiratory distress syndrome. Cochrane Database Syst Rev. 2024 Jan 25;1(1):CD008309. doi: 10.1002/14651858.CD008309.pub3.
- Derived from this study: PubMed 42551730Larsson M, Vu H, Nguyen LT, Nguyen HL, Nguyen HT, Tran NL, Nguyen H, Thi Pham PT, Nguyen TK, Elfvin A, Drevhammar T, Mai HT, Myrnerts Hook S, Alfven T, Pejovic NJ. Feasibility of Surfactant Delivery via Preterm Supraglottic Airways in Infants with Birth Weights of 800-1500 g. J Pediatr. 2026 Aug 4;299:115269. doi: 10.1016/j.jpeds.2026.115269. Online ahead of print.
- Individual participant dataSharing planned: Yes. The datasets used and/or analysed during the current study will be available from the principal investigator on reasonable request after publication of results.
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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.
Tobias Alfvén, Professor, M.D, Ph.D principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surfactant Administration Through Laryngeal or Supraglottic Airways in people with Respiratory Distress Syndrome, Newborn, run by Karolinska Institutet at 1 site in Vietnam.
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 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 19 Aug 2025. 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 Vietnam. 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?
Successful LMA placement, with signs of adequate airway, allowing two attempts. (time frame: During procedure. 0-30 minutes.). 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 NCT06606444, which also lists 2 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 19 Aug 2025.