Weaning FailureNCT02620358
Two Opposite Strategies of Weaning From Mechanical Ventilation
A study testing T Tube for 120 minuts and Pressure Support Ventilation of 8 cmH2O for 30 minutes in people with Weaning Failure, run by Althaia Xarxa Assistencial Universitària de Manresa.
Trial summary
This study compares two opposite strategies of weaning from Mechanical Ventilation. One of them is Low Pressure Support Ventilation during 30 minutes and the other is T-Tube for 2 hours. The aim of the study is to know witch one has a higher successful extubation rate. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Weaning Failure
- What is being tested?
- T Tube for 120 minuts and Pressure Support Ventilation of 8 cmH2O for 30 minutes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,190 participants
- Where
- No sites listed yet
- Study dates
- 11 Jan 2016to 28 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- More tan 18 years old
- More tan 24 hour of Mechanical Ventilation ready for weaning
Who cannot join
- Tracheostomy
- Non reintubation orders
About this study
Official title: Two Opposite Strategies of Weaning From Mechanical Ventilation: High Work of Breathing Versus Low Work of Breathing
This study compares two opposite strategies of weaning from Mechanical Ventilation. One of them is Low Pressure Support Ventilation during 30 minutes and the other is T-Tube for 2 hours. The aim of the study is to know witch one has a higher successful extubation rate.
Read the detailed description
The final stage of weaning from Mechanical Ventilation is known as Spontaneous Breathing Test (SBT). Some studies in the last 20 years have compared different strategies of weaning.
The SBT using T-Tube versus Low Pressure Support Ventilation (PSV) for 2 hours didn't show differences in successful extubation.
No difference in successful extubation rate were seen with the T-Tube for 30 or 120 minutes, or the Low PSV for 30 minutes or 2 hours For this reason the actual guidelines recommend to use T-Tube or Low PSV from 30 minutes to 2 hours with the same level of evidence.
Nevertheless, no studies have compared two opposite strategies like T-Tube for 2 hours (High work of breathing) versus Low PSV for only 30 minutes (Low work of breathing). Whereas the high work of breathing approach can be more specific for detecting more fitted patients, the low work of breathing method may reduce fatigue during SBT allowing more patients to be extubated.
We have designed a prospective, multicentric controlled and randomized study to compare this two opposite strategies of weaning: T-Tube for 120 minutes versus PSV 8 cmH2O for 30 minutes.
When patients show weaning criteria the randomly assigned SBT will be done.
We consider weaning criteria:
- Adequate cough
- Not too many respiratory secretions.
- Primary pathology solved.
- Clinical stability: Heart Rate (HR) < 140 bpm, Systolic Blood Pressure (SBP) 90-160 mmHg.
- Correct oxygenation: SatO2 > 90% with FiO2 < 0,4.
- Correct ventilatory pattern: Respiratory rate (RR) < 35 pm, Maximal Inspiratory Pressure (MIP) < -20 cmH2O, Tidal volume (TV) > 10 ml/kg, RR/TV < 100 pm/l.
- Adequate level of consciousness
Patients who succeed SBT will be extubated. Patients who fail SBT will be reconnected to the ventilator in the previous modality. These patients won't be randomized in future SBT.
We consider SBT failure:
Subjective Index:
- Neurological: Agitation or anxiety, Low level of consciousness.
- Increased work of breathing: accessory muscle use, dyspnea.
Objective Index:
- Hypoxemia: PaO2 < 60 mmHg or SatO2 < 90% with FiO2 > 50%.
- Tachypnea: RR > 35 pm.
- Hemodynamic instability: HR > 140 bpm, SBP > 180 mmHg, Arrhythmia.
Extubation failure will be registered within the first 72 hours after extubation.
We consider extubation failure:
- Respiratory acidosis: pH < 7,32, PaCO2 > 45 mmHg.
- Hypoxemia: SatO2 < 90% or PaO2 < 60 mmHg with FiO2 > 0,5.
- Deteriorating level of consciousness, Glasgow Coma Scale < 13.
- Uncontrolled agitation.
- Signs of fatigue.
Treatment of extubation failure will be decided by the attending physician: Reintubation, High Flow Oxygen therapy or Non Invasive Ventilation.
Reintubated patients won't be randomized in future SBT.
An interim analysis will be done when half of the simple is recruited.
Successful extubation will be analyzed by Kaplan-Meier survivial curves and logistic multivariable analysis with confounding variables.
- Conditions
- Weaning Failure
- Being tested
- T Tube for 120 minuts, Pressure Support Ventilation of 8 cmH2O for 30 minutes
- Keywords
- Mechanical Ventilation, Weaning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T Tube for 120 minutsOther
Spontaneous Breathing Trial using T Tube for 120 minutes.
Pressure Support Ventilation of 8 cmH2O for 30 minutesOther
Spontaneous Breathing Trial using Pressure Support Ventilation of 8 cmH2O for 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| High Work of Breathing | Experimental | If patient has weaning criteria, a Spontaneous Breathing Trial (SBT) with T Tube for 2 hours will be done.
The patient will be extubated after the SBT if he has no criteria of SBT failure. Receives: Other: T Tube for 120 minuts |
| Low Work of Breathing | Experimental | If patient has weaning criteria a Spontaneous Breathing Trial (SBT) with Pressure Support Ventilation of 8 cmH2O for 30 minutes will be done.
The patient will be extubated after the SBT if he has no criteria of SBT failure. Receives: Other: Pressure Support Ventilation of 8 cmH2O for 30 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Succesful extubation rate
Rate of succesful extubation after one of the weaning strategy
Measured: 72 hours
Secondary outcomes (4)
ICU Length of Stay
Define the ICU Length os Stay of each group
Measured: 3 month
Hospital Length of Stay
Define the Hospital Length of Stay of each group
Measured: 3 month
Mortality
Definte mortality rate of each group
Measured: 3 month
Reintubation rate
Rate of reintubation in each group the first 72 hours
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study start11 Jan 2016
- Primary completion28 Mar 2017
- Study completion28 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Weaning 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
- 1,190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Althaia Xarxa Assistencial Universitària de Manresa
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Reina Sofia de Cordoba, Hospital of Navarra, Hospital Universitario Marqués de Valdecilla, Hospital de Toledo, Hospital del Mar, Hospital de Mataró, Hospital de Sabadell, Hospital de Sant Joan Despí Moisès Broggi, Consorci Sanitari de Terrassa, Hospital Mutua de Terrassa, Hospital Universitari Joan XXIII de Tarragona., Hospital General Universitario de Alicante, Hospital General Universitario Elche, Hospital Clínico Universitario de Valencia, Complejo Hospitalario Universitario de Badajoz, Complejo Hospitalario Universitario de Santiago, Complexo Hospitalario de Ourense, Complejo Hospitalario Universitario de Vigo, Hospital de Henares, Hospital General Universitario Gregorio Marañon, Hospital Universitario Rey Juan Carlos, Hospital Universitario Infanta Cristina, Hospital Universitario Central de Asturias, Hospital General Universitario Morales Meseguer, Hospital Universitario Araba, Hospital Universitario de Canarias, Complejo Hospitalario de Caceres, Hospital de Sagunto, Hospital de Granollers, Hospital Universitari de Bellvitge
- Responsible party
- Principal investigator, Carles Subirà Cuyàs, Althaia Xarxa Assistencial Universitària de Manresa
- Investigators
- Fernandez Rafael, MD, Study director, Althaia Xarxa Assistencial Manresa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620358
- Sponsor's protocol ID
- CEIC 15/82
- Status last verified
- Mar 2017
- First submitted
- 20 Nov 2015
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Perren A, Domenighetti G, Mauri S, Genini F, Vizzardi N. Protocol-directed weaning from mechanical ventilation: clinical outcome in patients randomized for a 30-min or 120-min trial with pressure support ventilation. Intensive Care Med. 2002 Aug;28(8):1058-63. doi: 10.1007/s00134-002-1353-z. Epub 2002 Jul 13.
PubMed 12185425Esteban A, Anzueto A, Alia I, Gordo F, Apezteguia C, Palizas F, Cide D, Goldwaser R, Soto L, Bugedo G, Rodrigo C, Pimentel J, Raimondi G, Tobin MJ. How is mechanical ventilation employed in the intensive care unit? An international utilization review. Am J Respir Crit Care Med. 2000 May;161(5):1450-8. doi: 10.1164/ajrccm.161.5.9902018.
PubMed 10806138Brochard L, Rauss A, Benito S, Conti G, Mancebo J, Rekik N, Gasparetto A, Lemaire F. Comparison of three methods of gradual withdrawal from ventilatory support during weaning from mechanical ventilation. Am J Respir Crit Care Med. 1994 Oct;150(4):896-903. doi: 10.1164/ajrccm.150.4.7921460.
PubMed 7921460Esteban A, Alia I, Tobin MJ, Gil A, Gordo F, Vallverdu I, Blanch L, Bonet A, Vazquez A, de Pablo R, Torres A, de La Cal MA, Macias S. Effect of spontaneous breathing trial duration on outcome of attempts to discontinue mechanical ventilation. Spanish Lung Failure Collaborative Group. Am J Respir Crit Care Med. 1999 Feb;159(2):512-8. doi: 10.1164/ajrccm.159.2.9803106.
PubMed 9927366Esteban A, Alia I, Gordo F, Fernandez R, Solsona JF, Vallverdu I, Macias S, Allegue JM, Blanco J, Carriedo D, Leon M, de la Cal MA, Taboada F, Gonzalez de Velasco J, Palazon E, Carrizosa F, Tomas R, Suarez J, Goldwasser RS. Extubation outcome after spontaneous breathing trials with T-tube or pressure support ventilation. The Spanish Lung Failure Collaborative Group. Am J Respir Crit Care Med. 1997 Aug;156(2 Pt 1):459-65. doi: 10.1164/ajrccm.156.2.9610109.
PubMed 9279224Esteban A, Anzueto A, Frutos F, Alia I, Brochard L, Stewart TE, Benito S, Epstein SK, Apezteguia C, Nightingale P, Arroliga AC, Tobin MJ; Mechanical Ventilation International Study Group. Characteristics and outcomes in adult patients receiving mechanical ventilation: a 28-day international study. JAMA. 2002 Jan 16;287(3):345-55. doi: 10.1001/jama.287.3.345.
PubMed 11790214Subira C, Hernandez G, Vazquez A, Rodriguez-Garcia R, Gonzalez-Castro A, Garcia C, Rubio O, Ventura L, Lopez A, de la Torre MC, Keough E, Arauzo V, Hermosa C, Sanchez C, Tizon A, Tenza E, Laborda C, Cabanes S, Lacueva V, Del Mar Fernandez M, Arnau A, Fernandez R. Effect of Pressure Support vs T-Piece Ventilation Strategies During Spontaneous Breathing Trials on Successful Extubation Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial. JAMA. 2019 Jun 11;321(22):2175-2182. doi: 10.1001/jama.2019.7234.
PubMed 31184740
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Opposite Strategies of Weaning From Mechanical Ventilation: High Work of Breathing Versus Low Work of Breathing
- ClinicalTrials.gov ID
- NCT02620358
- Acronym / sponsor ID
- CEIC 15/82
- Conditions
- Weaning Failure
- Keywords
- Mechanical Ventilation, Weaning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,190 participants (actual)
- Lead sponsor
- Althaia Xarxa Assistencial Universitària de ManresaUniversity, hospital or other
- Collaborators
- Hospital Universitario Reina Sofia de Cordoba, Hospital of Navarra, Hospital Universitario Marqués de Valdecilla, Hospital de Toledo, Hospital del Mar, Hospital de Mataró, Hospital de Sabadell, Hospital de Sant Joan Despí Moisès Broggi, Consorci Sanitari de Terrassa, Hospital Mutua de Terrassa, Hospital Universitari Joan XXIII de Tarragona., Hospital General Universitario de Alicante, Hospital General Universitario Elche, Hospital Clínico Universitario de Valencia, Complejo Hospitalario Universitario de Badajoz, Complejo Hospitalario Universitario de Santiago, Complexo Hospitalario de Ourense, Complejo Hospitalario Universitario de Vigo, Hospital de Henares, Hospital General Universitario Gregorio Marañon, Hospital Universitario Rey Juan Carlos, Hospital Universitario Infanta Cristina, Hospital Universitario Central de Asturias, Hospital General Universitario Morales Meseguer, Hospital Universitario Araba, Hospital Universitario de Canarias, Complejo Hospitalario de Caceres, Hospital de Sagunto, Hospital de Granollers, Hospital Universitari de Bellvitge
- Study start
- 11 Jan 2016 (actual)
- Primary completion
- 28 Mar 2017 (actual)
- Study completion
- 28 Mar 2017 (actual)
- First posted
- 3 Dec 2015 (estimated)
- 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.
This study compares two opposite strategies of weaning from Mechanical Ventilation. One of them is Low Pressure Support Ventilation during 30 minutes and the other is T-Tube for 2 hours. The aim of the study is to know witch one has a higher successful extubation rate.
Detailed description
The final stage of weaning from Mechanical Ventilation is known as Spontaneous Breathing Test (SBT). Some studies in the last 20 years have compared different strategies of weaning.
The SBT using T-Tube versus Low Pressure Support Ventilation (PSV) for 2 hours didn't show differences in successful extubation.
No difference in successful extubation rate were seen with the T-Tube for 30 or 120 minutes, or the Low PSV for 30 minutes or 2 hours For this reason the actual guidelines recommend to use T-Tube or Low PSV from 30 minutes to 2 hours with the same level of evidence.
Nevertheless, no studies have compared two opposite strategies like T-Tube for 2 hours (High work of breathing) versus Low PSV for only 30 minutes (Low work of breathing). Whereas the high work of breathing approach can be more specific for detecting more fitted patients, the low work of breathing method may reduce fatigue during SBT allowing more patients to be extubated.
We have designed a prospective, multicentric controlled and randomized study to compare this two opposite strategies of weaning: T-Tube for 120 minutes versus PSV 8 cmH2O for 30 minutes.
When patients show weaning criteria the randomly assigned SBT will be done.
We consider weaning criteria:
- Adequate cough
- Not too many respiratory secretions.
- Primary pathology solved.
- Clinical stability: Heart Rate (HR) < 140 bpm, Systolic Blood Pressure (SBP) 90-160 mmHg.
- Correct oxygenation: SatO2 > 90% with FiO2 < 0,4.
- Correct ventilatory pattern: Respiratory rate (RR) < 35 pm, Maximal Inspiratory Pressure (MIP) < -20 cmH2O, Tidal volume (TV) > 10 ml/kg, RR/TV < 100 pm/l.
- Adequate level of consciousness
Patients who succeed SBT will be extubated. Patients who fail SBT will be reconnected to the ventilator in the previous modality. These patients won't be randomized in future SBT.
We consider SBT failure:
Subjective Index:
- Neurological: Agitation or anxiety, Low level of consciousness.
- Increased work of breathing: accessory muscle use, dyspnea.
Objective Index:
- Hypoxemia: PaO2 < 60 mmHg or SatO2 < 90% with FiO2 > 50%.
- Tachypnea: RR > 35 pm.
- Hemodynamic instability: HR > 140 bpm, SBP > 180 mmHg, Arrhythmia.
Extubation failure will be registered within the first 72 hours after extubation.
We consider extubation failure:
- Respiratory acidosis: pH < 7,32, PaCO2 > 45 mmHg.
- Hypoxemia: SatO2 < 90% or PaO2 < 60 mmHg with FiO2 > 0,5.
- Deteriorating level of consciousness, Glasgow Coma Scale < 13.
- Uncontrolled agitation.
- Signs of fatigue.
Treatment of extubation failure will be decided by the attending physician: Reintubation, High Flow Oxygen therapy or Non Invasive Ventilation.
Reintubated patients won't be randomized in future SBT.
An interim analysis will be done when half of the simple is recruited.
Successful extubation will be analyzed by Kaplan-Meier survivial curves and logistic multivariable analysis with confounding variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Work of Breathing | Experimental | Other: T Tube for 120 minutsIf patient has weaning criteria, a Spontaneous Breathing Trial (SBT) with T Tube for 2 hours will be done. The patient will be extubated after the SBT if he has no criteria of SBT failure. |
| Low Work of Breathing | Experimental | Other: Pressure Support Ventilation of 8 cmH2O for 30 minutesIf patient has weaning criteria a Spontaneous Breathing Trial (SBT) with Pressure Support Ventilation of 8 cmH2O for 30 minutes will be done. The patient will be extubated after the SBT if he has no criteria of SBT failure. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- More tan 18 years old
- More tan 24 hour of Mechanical Ventilation ready for weaning
Key exclusion criteria (2 listed)
- Tracheostomy
- Non reintubation orders
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 |
|---|---|---|
| T Tube for 120 minutsSpontaneous Breathing Trial using T Tube for 120 minutes. | Other | High Work of Breathing |
| Pressure Support Ventilation of 8 cmH2O for 30 minutesSpontaneous Breathing Trial using Pressure Support Ventilation of 8 cmH2O for 30 minutes | Other | Low Work of Breathing |
Primary outcome
Succesful extubation rate
Time frame: 72 hours
Rate of succesful extubation after one of the weaning strategy
4 secondary outcomes
ICU Length of Stay
Time frame: 3 month
Hospital Length of Stay
Time frame: 3 month
Mortality
Time frame: 3 month
Reintubation rate
Time frame: 72 hours
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 31 Mar 2017.
- Background: PubMed 12185425Perren A, Domenighetti G, Mauri S, Genini F, Vizzardi N. Protocol-directed weaning from mechanical ventilation: clinical outcome in patients randomized for a 30-min or 120-min trial with pressure support ventilation. Intensive Care Med. 2002 Aug;28(8):1058-63. doi: 10.1007/s00134-002-1353-z. Epub 2002 Jul 13.
- Background: PubMed 10806138Esteban A, Anzueto A, Alia I, Gordo F, Apezteguia C, Palizas F, Cide D, Goldwaser R, Soto L, Bugedo G, Rodrigo C, Pimentel J, Raimondi G, Tobin MJ. How is mechanical ventilation employed in the intensive care unit? An international utilization review. Am J Respir Crit Care Med. 2000 May;161(5):1450-8. doi: 10.1164/ajrccm.161.5.9902018.
- Results publication: PubMed 7921460Brochard L, Rauss A, Benito S, Conti G, Mancebo J, Rekik N, Gasparetto A, Lemaire F. Comparison of three methods of gradual withdrawal from ventilatory support during weaning from mechanical ventilation. Am J Respir Crit Care Med. 1994 Oct;150(4):896-903. doi: 10.1164/ajrccm.150.4.7921460.
- Results publication: PubMed 9927366Esteban A, Alia I, Tobin MJ, Gil A, Gordo F, Vallverdu I, Blanch L, Bonet A, Vazquez A, de Pablo R, Torres A, de La Cal MA, Macias S. Effect of spontaneous breathing trial duration on outcome of attempts to discontinue mechanical ventilation. Spanish Lung Failure Collaborative Group. Am J Respir Crit Care Med. 1999 Feb;159(2):512-8. doi: 10.1164/ajrccm.159.2.9803106.
- Results publication: PubMed 9279224Esteban A, Alia I, Gordo F, Fernandez R, Solsona JF, Vallverdu I, Macias S, Allegue JM, Blanco J, Carriedo D, Leon M, de la Cal MA, Taboada F, Gonzalez de Velasco J, Palazon E, Carrizosa F, Tomas R, Suarez J, Goldwasser RS. Extubation outcome after spontaneous breathing trials with T-tube or pressure support ventilation. The Spanish Lung Failure Collaborative Group. Am J Respir Crit Care Med. 1997 Aug;156(2 Pt 1):459-65. doi: 10.1164/ajrccm.156.2.9610109.
- Results publication: PubMed 11790214Esteban A, Anzueto A, Frutos F, Alia I, Brochard L, Stewart TE, Benito S, Epstein SK, Apezteguia C, Nightingale P, Arroliga AC, Tobin MJ; Mechanical Ventilation International Study Group. Characteristics and outcomes in adult patients receiving mechanical ventilation: a 28-day international study. JAMA. 2002 Jan 16;287(3):345-55. doi: 10.1001/jama.287.3.345.
- Derived from this study: PubMed 31184740Subira C, Hernandez G, Vazquez A, Rodriguez-Garcia R, Gonzalez-Castro A, Garcia C, Rubio O, Ventura L, Lopez A, de la Torre MC, Keough E, Arauzo V, Hermosa C, Sanchez C, Tizon A, Tenza E, Laborda C, Cabanes S, Lacueva V, Del Mar Fernandez M, Arnau A, Fernandez R. Effect of Pressure Support vs T-Piece Ventilation Strategies During Spontaneous Breathing Trials on Successful Extubation Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial. JAMA. 2019 Jun 11;321(22):2175-2182. doi: 10.1001/jama.2019.7234.
- 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.
Fernandez Rafael, MD study director
Althaia Xarxa Assistencial Manresa
Questions about this trial
What is this clinical trial studying?
A study testing T Tube for 120 minuts and Pressure Support Ventilation of 8 cmH2O for 30 minutes in people with Weaning Failure, run by Althaia Xarxa Assistencial Universitària de Manresa.
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 2 inclusion and 2 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 31 Mar 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?
Succesful extubation rate (time frame: 72 hours). 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 NCT02620358, which also lists 7 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 31 Mar 2017.