Respiratory FailureNCT03342781
Using HFNC in Bronchiolitis
A study testing high flow nasal oxygen therapy and Diffuser oxygen mask in people with Respiratory Failure and Bronchiolitis, run by Kayseri Training and Research Hospital.
Trial summary
The investigators compared oxygen therapy using the HFNC and diffuser mask (an effective low-flow oxygen delivery system) to treat patients with moderate-to-severe acute bronchiolitis admitted to an intensive care unit (ICU). Read more about this study
- Who is it for?
- Ages 1 month to 24 months
- Conditions the study is for
- Respiratory Failure, Bronchiolitis
- What is being tested?
- high flow nasal oxygen therapy and Diffuser oxygen mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to 1 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 month to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Included patients were aged between 1 and 24 months and had been diagnosed with moderate or severe acute bronchiolitis. They were admitted to the ICU, requiring supplemental oxygen, because their SpO2 measurements were less than 94% while breathing room air.
Who cannot join
- Any patients requiring immediate respiratory support (non-invasive or invasive mechanical ventilation, altered mental status, or apnea at presentation), those already admitted to the ICU due to respiratory failure, those with underlying chronic lung disease or cardiovascular disorders, those with obstructions of the upper respiratory tract, and those with cranial malformations were excluded.
About this study
Official title: Using a High-flow Nasal Cannula Provided Superior Results to Diffuser Delivery in Severe Bronchiolitis: a Prospective, Randomized Controlled Study
The investigators compared oxygen therapy using the HFNC and diffuser mask (an effective low-flow oxygen delivery system) to treat patients with moderate-to-severe acute bronchiolitis admitted to an intensive care unit (ICU).
Read the detailed description
Acute bronchiolitis results from inflammation of the bronchioles and is usually caused by a viral infection. It is most common in children younger than 2 years old and is one of the most frequent reasons why a child is admitted to hospital. There is no established, specific therapy for acute bronchiolitis and it is commonly treated using supplemental oxygen and by ensuring that the patient remains hydrated.
Oxygen therapy can be applied using a low- or high-flow oxygen delivery system. For example, a diffuser mask (OxyMask) is a low-flow delivery system, which is capable of delivering up to 90% of the fraction of inspired oxygen (FiO2) with low carbon dioxide (CO2) retention. In this system, the FiO2 can be adjusted by modifying the flow velocity to deliver the quantity of oxygen that the patient requires. Oxygen is supplied to the patient in a jet that flows from a device mounted on the oxygen mask. This ensures that a high concentration of oxygen is provided at a low flow rate. Additionally, CO2 retention is minimal because the mask has a fenestrated structure. Therefore, a diffuser mask is a more effective oxygen delivery method than many other low-flow delivery systems including the nasal cannula and simple oxygen mask.
Oxygen therapy using a high-flow nasal cannula (HFNC) is a high-flow oxygen delivery system that enhances the efficiency of respiration by using high flow rates to clear dead space and provide fresh oxygen. This system supplies oxygen at a high flow rate through a loose nasal cannula. HFNC therapy provides heated and humidified oxygen to fill the dead space in the nasopharynx and produces minimal positive airway pressure. It enhances the passage of air through the airway by reducing inspiratory pressure. Previous studies have demonstrated that using a HFNC can decrease respiratory effort and improve gas exchange. In recent years, many studies have suggested that high-flow nasal oxygen therapy is more effective than low-flow systems. This is substantiated by significant decreases in the use of mechanical ventilation since HFNC therapy was introduced.
Previous reports on the effectiveness of HFNC therapy in treating acute bronchiolitis have come primarily from observational work and there are few relevant, randomized controlled studies. Additionally, previous studies have compared HFNC therapy with less effective, low-flow systems (e.g., the simple mask or nasal cannula). To the best of our knowledge, no randomized controlled trial has compared the effectiveness of the HFNC and diffuser mask in treating bronchiolitis.
In this study, the investigators compared oxygen therapy using the HFNC and diffuser mask (an effective low-flow oxygen delivery system) to treat patients with moderate-to-severe acute bronchiolitis admitted to an intensive care unit (ICU).
- Conditions
- Respiratory Failure, Bronchiolitis
- Being tested
- high flow nasal oxygen therapy, Diffuser oxygen mask
- Keywords
- bronchiolitis, diffuser mask, high-flow nasal oxygen, pediatric intensive-care unit
- Medical subject headings
- Respiratory Insufficiency, Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high flow nasal oxygen therapyDevice
Oxygen therapy using a high-flow nasal cannula (HFNC) is a high-flow oxygen delivery system that enhances the efficiency of respiration by using high flow rates to clear dead space and provide fresh oxygen. This system supplies oxygen at a high flow rate through a loose nasal cannula.
Diffuser oxygen maskDevice
diffuser mask is a low-flow delivery system, which is capable of delivering up to 90% of the fraction of inspired oxygen (FiO2) with low CO2 retention. In this system, the FiO2 can be adjusted by modifying the flow velocity to deliver the quantity of oxygen that the patient requires. Oxygen is supplied to the patient in a jet that flows from a device mounted on the oxygen mask. This ensures that a high concentration of oxygen is provided at a low flow rate.
| Study group | Role | What they receive |
|---|---|---|
| Diffuser-mask group | Active comparator | The patients received oxygen therapy (8-15 L/min) from an OxyMask (Southmedic, Inc., Barrie, ON, Canada) to maintain oxygen saturation (SpO2) > 92%. Oxygen therapy was halted if SpO2 was maintained at a level greater than 92% for more than 4 h. The oxygen flow rate was then decreased to 2 L/min and the patient was monitored while breathing room air. Receives: Device: Diffuser oxygen mask |
| HFNC group | Active comparator | The patients received oxygen therapy at a high flow rate from a Precision Flow nasal cannula (Vapotherm, Inc., Stevensville, MD, USA). We selected a 1.9 mm pediatric cannula, which can dispense 1-20 L/min of oxygen. The initial oxygen flow rate was 1 L/kg/min and the FiO2 was 100%. The initial flow rate was increased by 1 L/kg/min until the SpO2 reached 92%. The initial FiO2 was decreased once the SpO2 was greater than 92% and the oxygen flow rate was maintained. HFNC therapy was halted if SpO2 was maintained at a level greater than 92% for more than 4 h at a FiO2 value of 21%, and the patient was transferred to a ward. Receives: Device: high flow nasal oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of treatment failure
Treatment failure was defined as meeting two of the following criteria [16]:
- No change or an increase in respiration rate compared with baseline.
- No change or an increase in heart rate compared with baseline.
- Persistence of low SpO2 (<%92) measurements despite an adequate oxygen flow rate and FiO2 in the HFNC group/oxygen flow rate of 15 L/min in the mask group.
Measured: up to 1 month
Secondary outcomes (3)
total duration of oxygen therapy
Measured: up to 1 month
Length of hospital stay day
Measured: up to 1 month
time of treatment failure
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Mar 2016
- Primary completion1 Dec 2016
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ayse Betul Ergul, Kayseri Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03342781
- Sponsor's protocol ID
- 2016/504
- Status last verified
- Nov 2017
- First submitted
- 2 Nov 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tapiainen T, Aittoniemi J, Immonen J, Jylkka H, Meinander T, Nuolivirta K, Peltola V, Salo E, Seuri R, Walle SM, Korppi M. Finnish guidelines for the treatment of laryngitis, wheezing bronchitis and bronchiolitis in children. Acta Paediatr. 2016 Jan;105(1):44-9. doi: 10.1111/apa.13162. Epub 2015 Nov 6.
PubMed 26295564Kose S, Sehriyaroglu A, Esen F, Ozdemir A, Kardas Z, Altug U, Karakus E, Ozcan A, Kisaarslan AF, Elmali F, Torun YA, Kose M. Comparing the Efficacy of 7%, 3% and 0.9% Saline in Moderate to Severe Bronchiolitis in Infants. Balkan Med J. 2016 Mar;33(2):193-7. doi: 10.5152/balkanmedj.2016.16840. Epub 2016 Mar 1.
PubMed 27403389Paul JE, Hangan H, Hajgato J. The OxyMask() development and performance in healthy volunteers. Med Devices (Auckl). 2009;2:9-17. Epub 2008 Dec 11.
PubMed 22915909Beecroft JM, Hanly PJ. Comparison of the OxyMask and Venturi mask in the delivery of supplemental oxygen: pilot study in oxygen-dependent patients. Can Respir J. 2006 Jul-Aug;13(5):247-52. doi: 10.1155/2006/720320.
PubMed 16896425Ling E, McDonald L, Dinesen TR, DuVall D. The OxyArm - a new minimal contact oxygen delivery system for mouth or nose breathing. Can J Anaesth. 2002 Mar;49(3):297-301. doi: 10.1007/BF03020531.
PubMed 11861350Bressan S, Balzani M, Krauss B, Pettenazzo A, Zanconato S, Baraldi E. High-flow nasal cannula oxygen for bronchiolitis in a pediatric ward: a pilot study. Eur J Pediatr. 2013 Dec;172(12):1649-56. doi: 10.1007/s00431-013-2094-4. Epub 2013 Jul 31.
PubMed 23900520Pham TM, O'Malley L, Mayfield S, Martin S, Schibler A. The effect of high flow nasal cannula therapy on the work of breathing in infants with bronchiolitis. Pediatr Pulmonol. 2015 Jul;50(7):713-20. doi: 10.1002/ppul.23060. Epub 2014 May 21.
PubMed 24846750Hough JL, Pham TM, Schibler A. Physiologic effect of high-flow nasal cannula in infants with bronchiolitis. Pediatr Crit Care Med. 2014 Jun;15(5):e214-9. doi: 10.1097/PCC.0000000000000112.
PubMed 24705569Keenan SP, Sinuff T, Cook DJ, Hill NS. Does noninvasive positive pressure ventilation improve outcome in acute hypoxemic respiratory failure? A systematic review. Crit Care Med. 2004 Dec;32(12):2516-23. doi: 10.1097/01.ccm.0000148011.51681.e2.
PubMed 15599160ten Brink F, Duke T, Evans J. High-flow nasal prong oxygen therapy or nasopharyngeal continuous positive airway pressure for children with moderate-to-severe respiratory distress?*. Pediatr Crit Care Med. 2013 Sep;14(7):e326-31. doi: 10.1097/PCC.0b013e31828a894d.
PubMed 23842586Ralston SL, Lieberthal AS, Meissner HC, Alverson BK, Baley JE, Gadomski AM, Johnson DW, Light MJ, Maraqa NF, Mendonca EA, Phelan KJ, Zorc JJ, Stanko-Lopp D, Brown MA, Nathanson I, Rosenblum E, Sayles S 3rd, Hernandez-Cancio S; American Academy of Pediatrics. Clinical practice guideline: the diagnosis, management, and prevention of bronchiolitis. Pediatrics. 2014 Nov;134(5):e1474-502. doi: 10.1542/peds.2014-2742.
PubMed 25349312
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a High-flow Nasal Cannula Provided Superior Results to Diffuser Delivery in Severe Bronchiolitis: a Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03342781
- Acronym / sponsor ID
- 2016/504
- Conditions
- Respiratory Failure, Bronchiolitis
- Keywords
- bronchiolitis, diffuser mask, high-flow nasal oxygen, pediatric intensive-care unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kayseri Training and Research HospitalOther government
- Study start
- 1 Mar 2016
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 17 Nov 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 investigators compared oxygen therapy using the HFNC and diffuser mask (an effective low-flow oxygen delivery system) to treat patients with moderate-to-severe acute bronchiolitis admitted to an intensive care unit (ICU).
Detailed description
Acute bronchiolitis results from inflammation of the bronchioles and is usually caused by a viral infection. It is most common in children younger than 2 years old and is one of the most frequent reasons why a child is admitted to hospital. There is no established, specific therapy for acute bronchiolitis and it is commonly treated using supplemental oxygen and by ensuring that the patient remains hydrated.
Oxygen therapy can be applied using a low- or high-flow oxygen delivery system. For example, a diffuser mask (OxyMask) is a low-flow delivery system, which is capable of delivering up to 90% of the fraction of inspired oxygen (FiO2) with low carbon dioxide (CO2) retention. In this system, the FiO2 can be adjusted by modifying the flow velocity to deliver the quantity of oxygen that the patient requires. Oxygen is supplied to the patient in a jet that flows from a device mounted on the oxygen mask. This ensures that a high concentration of oxygen is provided at a low flow rate. Additionally, CO2 retention is minimal because the mask has a fenestrated structure. Therefore, a diffuser mask is a more effective oxygen delivery method than many other low-flow delivery systems including the nasal cannula and simple oxygen mask.
Oxygen therapy using a high-flow nasal cannula (HFNC) is a high-flow oxygen delivery system that enhances the efficiency of respiration by using high flow rates to clear dead space and provide fresh oxygen. This system supplies oxygen at a high flow rate through a loose nasal cannula. HFNC therapy provides heated and humidified oxygen to fill the dead space in the nasopharynx and produces minimal positive airway pressure. It enhances the passage of air through the airway by reducing inspiratory pressure. Previous studies have demonstrated that using a HFNC can decrease respiratory effort and improve gas exchange. In recent years, many studies have suggested that high-flow nasal oxygen therapy is more effective than low-flow systems. This is substantiated by significant decreases in the use of mechanical ventilation since HFNC therapy was introduced.
Previous reports on the effectiveness of HFNC therapy in treating acute bronchiolitis have come primarily from observational work and there are few relevant, randomized controlled studies. Additionally, previous studies have compared HFNC therapy with less effective, low-flow systems (e.g., the simple mask or nasal cannula). To the best of our knowledge, no randomized controlled trial has compared the effectiveness of the HFNC and diffuser mask in treating bronchiolitis.
In this study, the investigators compared oxygen therapy using the HFNC and diffuser mask (an effective low-flow oxygen delivery system) to treat patients with moderate-to-severe acute bronchiolitis admitted to an intensive care unit (ICU).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diffuser-mask group | Active comparator | Device: Diffuser oxygen maskThe patients received oxygen therapy (8-15 L/min) from an OxyMask (Southmedic, Inc., Barrie, ON, Canada) to maintain oxygen saturation (SpO2) > 92%. Oxygen therapy was halted if SpO2 was maintained at a level greater than 92% for more than 4 h. The oxygen flow rate was then decreased to 2 L/min and the patient was monitored while breathing room air. |
| HFNC group | Active comparator | Device: high flow nasal oxygen therapyThe patients received oxygen therapy at a high flow rate from a Precision Flow nasal cannula (Vapotherm, Inc., Stevensville, MD, USA). We selected a 1.9 mm pediatric cannula, which can dispense 1-20 L/min of oxygen. The initial oxygen flow rate was 1 L/kg/min and the FiO2 was 100%. The initial flow rate was increased by 1 L/kg/min until the SpO2 reached 92%. The initial FiO2 was decreased once the SpO2 was greater than 92% and the oxygen flow rate was maintained. HFNC therapy was halted if SpO2 was maintained at a level greater than 92% for more than 4 h at a FiO2 value of 21%, and the patient was transferred to a ward. |
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Included patients were aged between 1 and 24 months and had been diagnosed with moderate or severe acute bronchiolitis. They were admitted to the ICU, requiring supplemental oxygen, because their SpO2 measurements were less than 94% while breathing room air.
Key exclusion criteria (1 listed)
- Any patients requiring immediate respiratory support (non-invasive or invasive mechanical ventilation, altered mental status, or apnea at presentation), those already admitted to the ICU due to respiratory failure, those with underlying chronic lung disease or cardiovascular disorders, those with obstructions of the upper respiratory tract, and those with cranial malformations were excluded.
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 |
|---|---|---|
| high flow nasal oxygen therapyOxygen therapy using a high-flow nasal cannula (HFNC) is a high-flow oxygen delivery system that enhances the efficiency of respiration by using high flow rates to clear dead space and provide fresh oxygen. This system supplies oxygen at a high flow rate through a loose nasal cannula. | Device | HFNC group |
| Diffuser oxygen maskdiffuser mask is a low-flow delivery system, which is capable of delivering up to 90% of the fraction of inspired oxygen (FiO2) with low CO2 retention. In this system, the FiO2 can be adjusted by modifying the flow velocity to deliver the quantity of oxygen that the patient requires. Oxygen is supplied to the patient in a jet that flows from a device mounted on the oxygen mask. This ensures that a high concentration of oxygen is provided at a low flow rate. | Device | Diffuser-mask group |
Primary outcome
presence of treatment failure
Time frame: up to 1 month
Treatment failure was defined as meeting two of the following criteria [16]: 1. No change or an increase in respiration rate compared with baseline. 2. No change or an increase in heart rate compared with baseline. 3. Persistence of low SpO2 (<%92) measurements despite an adequate oxygen flow rate and FiO2 in the HFNC group/oxygen flow rate of 15 L/min in the mask group.
3 secondary outcomes
total duration of oxygen therapy
Time frame: up to 1 month
Length of hospital stay day
Time frame: up to 1 month
time of treatment failure
Time frame: up to 1 month
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 17 Nov 2017.
- Background: PubMed 26295564Tapiainen T, Aittoniemi J, Immonen J, Jylkka H, Meinander T, Nuolivirta K, Peltola V, Salo E, Seuri R, Walle SM, Korppi M. Finnish guidelines for the treatment of laryngitis, wheezing bronchitis and bronchiolitis in children. Acta Paediatr. 2016 Jan;105(1):44-9. doi: 10.1111/apa.13162. Epub 2015 Nov 6.
- Background: PubMed 27403389Kose S, Sehriyaroglu A, Esen F, Ozdemir A, Kardas Z, Altug U, Karakus E, Ozcan A, Kisaarslan AF, Elmali F, Torun YA, Kose M. Comparing the Efficacy of 7%, 3% and 0.9% Saline in Moderate to Severe Bronchiolitis in Infants. Balkan Med J. 2016 Mar;33(2):193-7. doi: 10.5152/balkanmedj.2016.16840. Epub 2016 Mar 1.
- Background: PubMed 22915909Paul JE, Hangan H, Hajgato J. The OxyMask() development and performance in healthy volunteers. Med Devices (Auckl). 2009;2:9-17. Epub 2008 Dec 11.
- Background: PubMed 16896425Beecroft JM, Hanly PJ. Comparison of the OxyMask and Venturi mask in the delivery of supplemental oxygen: pilot study in oxygen-dependent patients. Can Respir J. 2006 Jul-Aug;13(5):247-52. doi: 10.1155/2006/720320.
- Background: PubMed 11861350Ling E, McDonald L, Dinesen TR, DuVall D. The OxyArm - a new minimal contact oxygen delivery system for mouth or nose breathing. Can J Anaesth. 2002 Mar;49(3):297-301. doi: 10.1007/BF03020531.
- Background: PubMed 23900520Bressan S, Balzani M, Krauss B, Pettenazzo A, Zanconato S, Baraldi E. High-flow nasal cannula oxygen for bronchiolitis in a pediatric ward: a pilot study. Eur J Pediatr. 2013 Dec;172(12):1649-56. doi: 10.1007/s00431-013-2094-4. Epub 2013 Jul 31.
- Background: PubMed 24846750Pham TM, O'Malley L, Mayfield S, Martin S, Schibler A. The effect of high flow nasal cannula therapy on the work of breathing in infants with bronchiolitis. Pediatr Pulmonol. 2015 Jul;50(7):713-20. doi: 10.1002/ppul.23060. Epub 2014 May 21.
- Background: PubMed 24705569Hough JL, Pham TM, Schibler A. Physiologic effect of high-flow nasal cannula in infants with bronchiolitis. Pediatr Crit Care Med. 2014 Jun;15(5):e214-9. doi: 10.1097/PCC.0000000000000112.
- Background: PubMed 15599160Keenan SP, Sinuff T, Cook DJ, Hill NS. Does noninvasive positive pressure ventilation improve outcome in acute hypoxemic respiratory failure? A systematic review. Crit Care Med. 2004 Dec;32(12):2516-23. doi: 10.1097/01.ccm.0000148011.51681.e2.
- Background: PubMed 23842586ten Brink F, Duke T, Evans J. High-flow nasal prong oxygen therapy or nasopharyngeal continuous positive airway pressure for children with moderate-to-severe respiratory distress?*. Pediatr Crit Care Med. 2013 Sep;14(7):e326-31. doi: 10.1097/PCC.0b013e31828a894d.
- Background: PubMed 25349312Ralston SL, Lieberthal AS, Meissner HC, Alverson BK, Baley JE, Gadomski AM, Johnson DW, Light MJ, Maraqa NF, Mendonca EA, Phelan KJ, Zorc JJ, Stanko-Lopp D, Brown MA, Nathanson I, Rosenblum E, Sayles S 3rd, Hernandez-Cancio S; American Academy of Pediatrics. Clinical practice guideline: the diagnosis, management, and prevention of bronchiolitis. Pediatrics. 2014 Nov;134(5):e1474-502. doi: 10.1542/peds.2014-2742.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing high flow nasal oxygen therapy and Diffuser oxygen mask in people with Respiratory Failure and Bronchiolitis, run by Kayseri Training and Research 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 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 17 Nov 2017. 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?
presence of treatment failure (time frame: up to 1 month). 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 NCT03342781, which also lists 11 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 17 Nov 2017.