MyelomeningoceleNCT03088761
Cuff Pressure in Infants
An observational study of Myelomeningocele and Prone Position, run by Istanbul Science University.
Trial summary
The changes in the cuff pressure in the absence of nitrous oxide are less clear.In the current study, we aim to determine the changes in cuff pressure over time in infants undergoing myelomeningocele repair in prone position under general anesthesia in the absence of N2O. Read more about this study
- Who is it for?
- Ages 1 day to 30 days
- Conditions the study is for
- Myelomeningocele, Prone Position
- What is being tested?
- cuffed tracheal tube
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2017to 1 Oct 2017
- Phase
- Observational
- 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 day to 30 days
- All sexes
- No healthy volunteers
- Child
Study population: 1-30 days old infants undergoing meningomyelocele repair
Who may be able to join
- male and female infants undergoing meningomyelocele repair
Who cannot join
- tracheal intubation with uncuffed tube, the use of N2O during anesthesia, accompanying disease like hydrocephalus
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Changes in the Cuff Pressure in Infants in the Absence of Nitrous Oxide
The changes in the cuff pressure in the absence of nitrous oxide are less clear.In the current study, we aim to determine the changes in cuff pressure over time in infants undergoing myelomeningocele repair in prone position under general anesthesia in the absence of N2O.
Read the detailed description
Introduction:
During perioperative period some factors may change the endotracheal tube (ETT) cuff pressure. They include time (1), changes in core temperature (2), neuromuscular blockade (3), sedation (4), altitude (5), use of nitrous oxide (6,7), changes in tracheal muscle tone and respiratory system impedance (8), different body, head and neck positions (9), mechanical ventilation and transoesophageal echocardiography probe insertion (10).
Some have chosen to avoid the use of nitrous oxide (N2O) during surgery because of the theoretical risk of multiple deleterious effects on the neurologic, cardiovascular, hematologic and immune systems. In addition, N2O diffuses into all gas-filled cavities increasing their sizes and pressures including ETT cuffs (11). ETT cuff pressure increases after exposure to nitrous oxide (12).
However, the changes in the cuff pressure in the absence of nitrous oxide are less clear. Kako et al. (13) investigated the relationship between head and neck position and ETT cuff pressure in children in the absence of N2O in the supine position. In this study, 1000 intracuff readings were evaluated in 200 children based on position of the head and neck. They found that cuff pressure increased in two-thirds of the measurements 545 out of 1000 when compared with the neutral position. Most frequently change was noted with neck flexion. The mean increase in cuff pressure was 7.2±8.3 cmH2O from the neutral position (p<0.05).
In the current study, we aim to determine the changes in cuff pressure over time in infants undergoing myelomeningocele repair in prone position under general anesthesia in the absence of N2O.
Methods:
This prospective observational study was approved by the Institutional Review Board of Istanbul Science University. After parents are given a detailed explanation about of the procedure of ETT placement for general anesthesia, consent for their children's participation will be sought. The study will be registered at ClinicalTrials.gov.
Twenty infants undergoing repair of myelomeningocele will be recruited. Their airways will be secured with a cuffed ETT. All infants will undergo surgery in the prone position.
Anesthesia will be induced with a combination of oxygen, air, sevoflurane, intravenous remifentanil and rocuronium. After tracheal intubation with a high volume low pressure cuffed ETT (Nextech®, Istanbul, Turkey), the cuff will be inflated until there is no audible gas leak. The observer will check the gas leak using a stethoscope guided inflation over the trachea while holding continuous positive airway pressure of 20-25 cm H2O (14).
The ETT cuff pressures will be monitored simultaneously with a cuff manometer and pressure transducer (15). The measurements will be observed continuously. When the cuff pressure is noted to exceed 15 cmH2O, the cuff will be deflated immediately to less than 15 cmH2O. The time when the correction occurred, the time interval between corrections and the number of corrections during surgery will be recorded.
The baseline cuff pressure will be assessed in the supine position after which time a second measurement will be made in the prone position. A blind investigator will check and record the cuff pressure. If the pressure is between 10-15 cmH2O, no intervention will be performed. If the pressure exceeds 15 cmH2O, the cuff pressure will be managed as described above. The cuff pressures will be compared over time within patients. In addition, heart rate, end-tidal CO2, temperature and peak airway pressure will be recorded every 15 min.
Statistics:
All data that are normally distributed will be summarized as means ± standard deviation. Data that are not normally distributed will be summarized as medians and 25-75th percentile. Cuff pressure and all other interval data that will be measured over time will be analyzed using repeated-measures ANOVA with the Tukey (or Dunnett) post-hoc test. Comparing supine and prone positions, cuff pressures will be analyzed using two-way repeated measures ANOVA. Baseline demographic data will be compared using unpaired t-test for normally distributed data and Mann Whitney U test for data that are not normally distributed. P<0.05 will be accepted.
- Conditions
- Myelomeningocele, Prone Position
- Being tested
- cuffed tracheal tube
- Keywords
- tracheal tube, cuff pressure
- Medical subject headings
- Meningomyelocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cuffed tracheal tubeDevice
the changes in cuff pressure will be determined using a cuff manometer
| Study group | Role | What they receive |
|---|---|---|
| cuffed tube pressure group | The pressures of cuffed tracheal tubes will be monitored simultaneously with a cuff manometer and pressure transducer. The measurements will be observed continuously. When the cuff pressure is noted to exceed 15 cmH2O, the cuff will be deflated immediately to less than 15 cmH2O. The time when the correction occurred, the time interval between corrections and the number of corrections during surgery will be recorded.
The baseline cuff pressure will be assessed in the supine position after which time a second measurement will be made in the prone position. A blind investigator will check and record the findings of cuffed tracheal tube. Receives: Device: cuffed tracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change in cuff pressure
the change in cuff pressure will be recorded during prone position
Measured: four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start1 May 2017 (estimated)
- Primary completion30 Sep 2017 (estimated)
- Study completion1 Oct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for MyelomeningoceleStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kemal Tolga Saracoglu, Istanbul Science University
- Investigators
- Kemal T Saracoglu, Principal investigator, Istanbul Science University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088761
- Sponsor's protocol ID
- 44140529
- Status last verified
- Apr 2017
- First submitted
- 18 Mar 2017
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Motoyama A, Asai S, Konami H, Matsumoto Y, Misumi T, Imanaka H, Nishimura M. Changes in endotracheal tube cuff pressure in mechanically ventilated adult patients. J Intensive Care. 2014 Jan 31;2(1):7. doi: 10.1186/2052-0492-2-7. eCollection 2014.
PubMed 25520824Kako H, Alkhatib O, Krishna SG, Khan S, Naguib A, Tobias JD. Changes in intracuff pressure of a cuffed endotracheal tube during surgery for congenital heart disease using cardiopulmonary bypass. Paediatr Anaesth. 2015 Jul;25(7):705-10. doi: 10.1111/pan.12631. Epub 2015 Mar 4.
PubMed 25735902Lizy C, Swinnen W, Labeau S, Poelaert J, Vogelaers D, Vandewoude K, Dulhunty J, Blot S. Cuff pressure of endotracheal tubes after changes in body position in critically ill patients treated with mechanical ventilation. Am J Crit Care. 2014 Jan;23(1):e1-8. doi: 10.4037/ajcc2014489.
PubMed 24382623Nseir S, Brisson H, Marquette CH, Chaud P, Di Pompeo C, Diarra M, Durocher A. Variations in endotracheal cuff pressure in intubated critically ill patients: prevalence and risk factors. Eur J Anaesthesiol. 2009 Mar;26(3):229-34. doi: 10.1097/eja.0b013e3283222b6e.
PubMed 19244697Orsborn J, Graham J, Moss M, Melguizo M, Nick T, Stroud M. Pediatric Endotracheal Tube Cuff Pressures During Aeromedical Transport. Pediatr Emerg Care. 2016 Jan;32(1):20-2. doi: 10.1097/PEC.0000000000000365.
PubMed 25834962Beydon L, Gourgues M, Talec P. [Endotracheal tube cuff and nitrous oxide: bench evaluation and assessment of clinical practice]. Ann Fr Anesth Reanim. 2011 Sep;30(9):679-84. doi: 10.1016/j.annfar.2011.03.017. Epub 2011 Jun 25. French.
PubMed 21705180Tu HN, Saidi N, Leiutaud T, Bensaid S, Menival V, Duvaldestin P. Nitrous oxide increases endotracheal cuff pressure and the incidence of tracheal lesions in anesthetized patients. Anesth Analg. 1999 Jul;89(1):187-90. doi: 10.1097/00000539-199907000-00033.
PubMed 10389801Plotnikow GA, Roux N, Feld V, Gogniat E, Villalba D, Ribero NV, Sartore M, Bosso M, Quiroga C, Leiva V, Scrigna M, Puchulu F, Distefano E, Scapellato JL, Intile D, Planells F, Noval D, Bunirigo P, Jofre R, Nielsen ED. Evaluation of tracheal cuff pressure variation in spontaneously breathing patients. Int J Crit Illn Inj Sci. 2013 Oct;3(4):262-8. doi: 10.4103/2229-5151.124148.
PubMed 24459624Godoy AC, Vieira RJ, Capitani EM. Endotracheal tube cuff pressure alteration after changes in position in patients under mechanical ventilation. J Bras Pneumol. 2008 May;34(5):294-7. doi: 10.1590/s1806-37132008000500008. English, Portuguese.
PubMed 18545825Tan PH, Lin VC, Chen HS, Hung KC. The effect of transoesophageal echocardiography probe insertion on tracheal cuff pressure. Anaesthesia. 2011 Sep;66(9):791-5. doi: 10.1111/j.1365-2044.2011.06789.x. Epub 2011 Jun 24.
PubMed 21707563Tobias JD. Applications of nitrous oxide for procedural sedation in the pediatric population. Pediatr Emerg Care. 2013 Feb;29(2):245-65. doi: 10.1097/PEC.0b013e318280d824.
PubMed 23546436Maino P, Dullenkopf A, Bernet V, Weiss M. Nitrous oxide diffusion into the cuffs of disposable laryngeal mask airways. Anaesthesia. 2005 Mar;60(3):278-82. doi: 10.1111/j.1365-2044.2004.04072.x.
PubMed 15710013Kako H, Krishna SG, Ramesh AS, Merz MN, Elmaraghy C, Grischkan J, Jatana KR, Ruda J, Tobias JD. The relationship between head and neck position and endotracheal tube intracuff pressure in the pediatric population. Paediatr Anaesth. 2014 Mar;24(3):316-21. doi: 10.1111/pan.12308. Epub 2013 Nov 18.
PubMed 24238105Grant T. Do current methods for endotracheal tube cuff inflation create pressures above the recommended range? A review of the evidence. J Perioper Pract. 2013 Dec;23(12):292-5. doi: 10.1177/175045891302301205.
PubMed 24404708Krishna SG, Ramesh AS, Jatana KR, Elmaraghy C, Merz M, Ruda J, Tobias JD. A technique to measure the intracuff pressure continuously: an in vivo demonstration of its accuracy. Paediatr Anaesth. 2014 Sep;24(9):999-1004. doi: 10.1111/pan.12437. Epub 2014 May 24.
PubMed 24860935
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in the Cuff Pressure in Infants in the Absence of Nitrous Oxide
- ClinicalTrials.gov ID
- NCT03088761
- Acronym / sponsor ID
- 44140529
- Conditions
- Myelomeningocele, Prone Position
- Keywords
- tracheal tube, cuff pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Istanbul Science UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (estimated)
- Primary completion
- 30 Sep 2017 (estimated)
- Study completion
- 1 Oct 2017 (estimated)
- First posted
- 23 Mar 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 changes in the cuff pressure in the absence of nitrous oxide are less clear.In the current study, we aim to determine the changes in cuff pressure over time in infants undergoing myelomeningocele repair in prone position under general anesthesia in the absence of N2O.
Detailed description
Introduction:
During perioperative period some factors may change the endotracheal tube (ETT) cuff pressure. They include time (1), changes in core temperature (2), neuromuscular blockade (3), sedation (4), altitude (5), use of nitrous oxide (6,7), changes in tracheal muscle tone and respiratory system impedance (8), different body, head and neck positions (9), mechanical ventilation and transoesophageal echocardiography probe insertion (10).
Some have chosen to avoid the use of nitrous oxide (N2O) during surgery because of the theoretical risk of multiple deleterious effects on the neurologic, cardiovascular, hematologic and immune systems. In addition, N2O diffuses into all gas-filled cavities increasing their sizes and pressures including ETT cuffs (11). ETT cuff pressure increases after exposure to nitrous oxide (12).
However, the changes in the cuff pressure in the absence of nitrous oxide are less clear. Kako et al. (13) investigated the relationship between head and neck position and ETT cuff pressure in children in the absence of N2O in the supine position. In this study, 1000 intracuff readings were evaluated in 200 children based on position of the head and neck. They found that cuff pressure increased in two-thirds of the measurements 545 out of 1000 when compared with the neutral position. Most frequently change was noted with neck flexion. The mean increase in cuff pressure was 7.2±8.3 cmH2O from the neutral position (p<0.05).
In the current study, we aim to determine the changes in cuff pressure over time in infants undergoing myelomeningocele repair in prone position under general anesthesia in the absence of N2O.
Methods:
This prospective observational study was approved by the Institutional Review Board of Istanbul Science University. After parents are given a detailed explanation about of the procedure of ETT placement for general anesthesia, consent for their children's participation will be sought. The study will be registered at ClinicalTrials.gov.
Twenty infants undergoing repair of myelomeningocele will be recruited. Their airways will be secured with a cuffed ETT. All infants will undergo surgery in the prone position.
Anesthesia will be induced with a combination of oxygen, air, sevoflurane, intravenous remifentanil and rocuronium. After tracheal intubation with a high volume low pressure cuffed ETT (Nextech®, Istanbul, Turkey), the cuff will be inflated until there is no audible gas leak. The observer will check the gas leak using a stethoscope guided inflation over the trachea while holding continuous positive airway pressure of 20-25 cm H2O (14).
The ETT cuff pressures will be monitored simultaneously with a cuff manometer and pressure transducer (15). The measurements will be observed continuously. When the cuff pressure is noted to exceed 15 cmH2O, the cuff will be deflated immediately to less than 15 cmH2O. The time when the correction occurred, the time interval between corrections and the number of corrections during surgery will be recorded.
The baseline cuff pressure will be assessed in the supine position after which time a second measurement will be made in the prone position. A blind investigator will check and record the cuff pressure. If the pressure is between 10-15 cmH2O, no intervention will be performed. If the pressure exceeds 15 cmH2O, the cuff pressure will be managed as described above. The cuff pressures will be compared over time within patients. In addition, heart rate, end-tidal CO2, temperature and peak airway pressure will be recorded every 15 min.
Statistics:
All data that are normally distributed will be summarized as means ± standard deviation. Data that are not normally distributed will be summarized as medians and 25-75th percentile. Cuff pressure and all other interval data that will be measured over time will be analyzed using repeated-measures ANOVA with the Tukey (or Dunnett) post-hoc test. Comparing supine and prone positions, cuff pressures will be analyzed using two-way repeated measures ANOVA. Baseline demographic data will be compared using unpaired t-test for normally distributed data and Mann Whitney U test for data that are not normally distributed. P<0.05 will be accepted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cuffed tube pressure group | – | Device: cuffed tracheal tubeThe pressures of cuffed tracheal tubes will be monitored simultaneously with a cuff manometer and pressure transducer. The measurements will be observed continuously. When the cuff pressure is noted to exceed 15 cmH2O, the cuff will be deflated immediately to less than 15 cmH2O. The time when the correction occurred, the time interval between corrections and the number of corrections during surgery will be recorded. The baseline cuff pressure will be assessed in the supine position after which time a second measurement will be made in the prone position. A blind investigator will check and record the findings of cuffed tracheal tube. |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 1-30 days old infants undergoing meningomyelocele repair
Key inclusion criteria (1 listed)
- male and female infants undergoing meningomyelocele repair
Key exclusion criteria (1 listed)
- tracheal intubation with uncuffed tube, the use of N2O during anesthesia, accompanying disease like hydrocephalus
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 |
|---|---|---|
| cuffed tracheal tubethe changes in cuff pressure will be determined using a cuff manometer | Device | cuffed tube pressure group |
Primary outcome
the change in cuff pressure
Time frame: four months
the change in cuff pressure will be recorded during prone position
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- Results publication: PubMed 25520824Motoyama A, Asai S, Konami H, Matsumoto Y, Misumi T, Imanaka H, Nishimura M. Changes in endotracheal tube cuff pressure in mechanically ventilated adult patients. J Intensive Care. 2014 Jan 31;2(1):7. doi: 10.1186/2052-0492-2-7. eCollection 2014.
- Results publication: PubMed 25735902Kako H, Alkhatib O, Krishna SG, Khan S, Naguib A, Tobias JD. Changes in intracuff pressure of a cuffed endotracheal tube during surgery for congenital heart disease using cardiopulmonary bypass. Paediatr Anaesth. 2015 Jul;25(7):705-10. doi: 10.1111/pan.12631. Epub 2015 Mar 4.
- Results publication: PubMed 24382623Lizy C, Swinnen W, Labeau S, Poelaert J, Vogelaers D, Vandewoude K, Dulhunty J, Blot S. Cuff pressure of endotracheal tubes after changes in body position in critically ill patients treated with mechanical ventilation. Am J Crit Care. 2014 Jan;23(1):e1-8. doi: 10.4037/ajcc2014489.
- Results publication: PubMed 19244697Nseir S, Brisson H, Marquette CH, Chaud P, Di Pompeo C, Diarra M, Durocher A. Variations in endotracheal cuff pressure in intubated critically ill patients: prevalence and risk factors. Eur J Anaesthesiol. 2009 Mar;26(3):229-34. doi: 10.1097/eja.0b013e3283222b6e.
- Results publication: PubMed 25834962Orsborn J, Graham J, Moss M, Melguizo M, Nick T, Stroud M. Pediatric Endotracheal Tube Cuff Pressures During Aeromedical Transport. Pediatr Emerg Care. 2016 Jan;32(1):20-2. doi: 10.1097/PEC.0000000000000365.
- Results publication: PubMed 21705180Beydon L, Gourgues M, Talec P. [Endotracheal tube cuff and nitrous oxide: bench evaluation and assessment of clinical practice]. Ann Fr Anesth Reanim. 2011 Sep;30(9):679-84. doi: 10.1016/j.annfar.2011.03.017. Epub 2011 Jun 25. French.
- Results publication: PubMed 10389801Tu HN, Saidi N, Leiutaud T, Bensaid S, Menival V, Duvaldestin P. Nitrous oxide increases endotracheal cuff pressure and the incidence of tracheal lesions in anesthetized patients. Anesth Analg. 1999 Jul;89(1):187-90. doi: 10.1097/00000539-199907000-00033.
- Results publication: PubMed 24459624Plotnikow GA, Roux N, Feld V, Gogniat E, Villalba D, Ribero NV, Sartore M, Bosso M, Quiroga C, Leiva V, Scrigna M, Puchulu F, Distefano E, Scapellato JL, Intile D, Planells F, Noval D, Bunirigo P, Jofre R, Nielsen ED. Evaluation of tracheal cuff pressure variation in spontaneously breathing patients. Int J Crit Illn Inj Sci. 2013 Oct;3(4):262-8. doi: 10.4103/2229-5151.124148.
- Results publication: PubMed 18545825Godoy AC, Vieira RJ, Capitani EM. Endotracheal tube cuff pressure alteration after changes in position in patients under mechanical ventilation. J Bras Pneumol. 2008 May;34(5):294-7. doi: 10.1590/s1806-37132008000500008. English, Portuguese.
- Results publication: PubMed 21707563Tan PH, Lin VC, Chen HS, Hung KC. The effect of transoesophageal echocardiography probe insertion on tracheal cuff pressure. Anaesthesia. 2011 Sep;66(9):791-5. doi: 10.1111/j.1365-2044.2011.06789.x. Epub 2011 Jun 24.
- Results publication: PubMed 23546436Tobias JD. Applications of nitrous oxide for procedural sedation in the pediatric population. Pediatr Emerg Care. 2013 Feb;29(2):245-65. doi: 10.1097/PEC.0b013e318280d824.
- Results publication: PubMed 15710013Maino P, Dullenkopf A, Bernet V, Weiss M. Nitrous oxide diffusion into the cuffs of disposable laryngeal mask airways. Anaesthesia. 2005 Mar;60(3):278-82. doi: 10.1111/j.1365-2044.2004.04072.x.
- Individual participant dataSharing planned: Undecided
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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.
Kemal T Saracoglu principal investigator
Istanbul Science University School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Myelomeningocele and Prone Position, run by Istanbul Science University.
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: status not confirmed, as of the sponsor's last update on 13 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kemal T Saracoglu, MD (+905385478620, saracoglukt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change in cuff pressure (time frame: four months). 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 NCT03088761, which also lists 15 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 13 Apr 2017.