Chronic Respiratory FailureNCT03348085
Is Optimal Minute Ventilation a Predictor of Weaning in Patients With Prolong Mechanical Ventilation?
An observational study of Chronic Respiratory Failure, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation.
Trial summary
1. purpose of study: optimal minute could be the prediction of successful weaning and become the new weaning parameter. 2. study design: inclusion criteria: investigators will perform this study at our respiratory care center. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Respiratory Failure
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Dec 2016
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients are included in this study if they had been maintained on mechanical ventilation in excess of 3 weeks before respiratory care center admission, and all previous weaning attempts had failed. Patients are eligible for respiratory care center admission : hemodynamics stability, no vasoactive drug infusion for 24 hours or more before transfer, stable oxygen requirements(FIO2<40%,PERP<10 cmH2O), no hepatic failure, no requirement for surgical intervention within the 2 weeks, .
Who may be able to join
- patients who had been maintained on mechanical ventilation in excess of 3 weeks before respiratory care center admission and all previous weaning attempts had failed.
Who cannot join
- Patients do not have spontaneous breath. Patients do not use invasive mechanical ventilator. Terminal cancer stage and hemodynamics unstable.
About this study
Official title: Taipei Tzu Chi Hospital , Buddhist Tzu Chi Medical Foundation
- purpose of study: optimal minute could be the prediction of successful weaning and become the new weaning parameter.
- study design: inclusion criteria: investigators will perform this study at our respiratory care center. Patients who had been maintained on mechanical ventilator in excess of 3 weeks before respiratory care center admission and all previous weaning attempts had ailed. Exclusion criteria: Patients do not have spontaneous breath. Terminal cancer stage and unstable hemodynamics condition.
- study duration: 2016/01/01~12/31
Read the detailed description
Investigators will preform this study at our respiratory care center. Initially, Investigators collected all physiological parameters and baseline characteristics of patients with prolong mechanical ventilator. Investigators use Gold-Galileo ventilator and patients use adaptive support ventilation mode. In adaptive support ventilation, the clinician enters a target minute volume , using a parameter called minute ventilation percentage. The minute ventilation percentage setting be initially set at 100% (the 100%minute ventilation setting), which provides a target minute ventilation of 0.1 L/min/kg of ideal body weight . Investigators observed respiratory frequency of patients, the minute ventilation percentage was increased every 5 min until the mandatory breath began to appear and spontaneous rate is zero. If the minute ventilation percentage had exceeded 250%, but patients do not have mandatory rate appeared, the optimal minute ventilation of the patient is means above 250%. Investigators also measure other weaning parameters. Finally, Investigators analyze the prediction of optimal minute ventilation as a weaning parameter.
- Conditions
- Chronic Respiratory Failure
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
The prediction of optimal minute ventilation as successful weaning parameters in patients with prolong mechanical ventilator.
Investigators observed the condition of patients with adaptive spontaneous ventilation mode that the patient admitted to respiratory care center first day
Measured: 2016/01/01~2016/12/31,1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start1 Jan 2016
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
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 Chronic 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- YaRu Liang, Study chair, Taipei Tzuchi hospital , Buddhist Tzu chi medical foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348085
- Sponsor's protocol ID
- 04-XD25-067
- Status last verified
- Jan 2016
- First submitted
- 16 Nov 2017
- Last updated
- 24 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ntoumenopoulos G. Rehabilitation during mechanical ventilation: Review of the recent literature. Intensive Crit Care Nurs. 2015 Jun;31(3):125-32. doi: 10.1016/j.iccn.2015.02.001. Epub 2015 May 27.
PubMed 26026495MacIntyre NR, Epstein SK, Carson S, Scheinhorn D, Christopher K, Muldoon S; National Association for Medical Direction of Respiratory Care. Management of patients requiring prolonged mechanical ventilation: report of a NAMDRC consensus conference. Chest. 2005 Dec;128(6):3937-54. doi: 10.1378/chest.128.6.3937.
PubMed 16354866King C, Moores LK. Controversies in mechanical ventilation: when should a tracheotomy be placed? Clin Chest Med. 2008 Jun;29(2):253-63, vi. doi: 10.1016/j.ccm.2008.01.002.
PubMed 18440435Scheinhorn DJ, Artinian BM, Catlin JL. Weaning from prolonged mechanical ventilation. The experience at a regional weaning center. Chest. 1994 Feb;105(2):534-9. doi: 10.1378/chest.105.2.534.
PubMed 8306758Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.
PubMed 18367735Frutos-Vivar F, Esteban A. Critical illness polyneuropathy: a new (or old?) reason for weaning failure. Crit Care Med. 2005 Feb;33(2):452-3. doi: 10.1097/01.ccm.0000153525.37281.d4. No abstract available.
PubMed 15699857Wu YK, Tsai YH, Lan CC, Huang CY, Lee CH, Kao KC, Fu JY. Prolonged mechanical ventilation in a respiratory-care setting: a comparison of outcome between tracheostomized and translaryngeal intubated patients. Crit Care. 2010;14(2):R26. doi: 10.1186/cc8890. Epub 2010 Mar 1.
PubMed 20193057Schonhofer B. [Effect on the duration of mechanical ventilation of identifying patients capable of breathing spontaneously]. Pneumologie. 1997 Jun;51(6):599-600. No abstract available. German.
PubMed 9333795Verceles AC, Diaz-Abad M, Geiger-Brown J, Scharf SM. Testing the prognostic value of the rapid shallow breathing index in predicting successful weaning in patients requiring prolonged mechanical ventilation. Heart Lung. 2012 Nov-Dec;41(6):546-52. doi: 10.1016/j.hrtlng.2012.06.003. Epub 2012 Jul 6.
PubMed 22770598Wu CP, Lin HI, Perng WC, Yang SH, Chen CW, Huang YC, Huang KL. Correlation between the %MinVol setting and work of breathing during adaptive support ventilation in patients with respiratory failure. Respir Care. 2010 Mar;55(3):334-41.
PubMed 20196884OTIS AB, MCKERROW CB, BARTLETT RA, MEAD J, MCILROY MB, SELVER-STONE NJ, RADFORD EP Jr. Mechanical factors in distribution of pulmonary ventilation. J Appl Physiol. 1956 Jan;8(4):427-43. doi: 10.1152/jappl.1956.8.4.427. No abstract available.
PubMed 13286206
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taipei Tzu Chi Hospital , Buddhist Tzu Chi Medical Foundation
- ClinicalTrials.gov ID
- NCT03348085
- Acronym / sponsor ID
- 04-XD25-067
- Conditions
- Chronic Respiratory Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 20 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.
- purpose of study: optimal minute could be the prediction of successful weaning and become the new weaning parameter.
- study design: inclusion criteria: investigators will perform this study at our respiratory care center. Patients who had been maintained on mechanical ventilator in excess of 3 weeks before respiratory care center admission and all previous weaning attempts had ailed. Exclusion criteria: Patients do not have spontaneous breath. Terminal cancer stage and unstable hemodynamics condition.
- study duration: 2016/01/01~12/31
Detailed description
Investigators will preform this study at our respiratory care center. Initially, Investigators collected all physiological parameters and baseline characteristics of patients with prolong mechanical ventilator. Investigators use Gold-Galileo ventilator and patients use adaptive support ventilation mode. In adaptive support ventilation, the clinician enters a target minute volume , using a parameter called minute ventilation percentage. The minute ventilation percentage setting be initially set at 100% (the 100%minute ventilation setting), which provides a target minute ventilation of 0.1 L/min/kg of ideal body weight . Investigators observed respiratory frequency of patients, the minute ventilation percentage was increased every 5 min until the mandatory breath began to appear and spontaneous rate is zero. If the minute ventilation percentage had exceeded 250%, but patients do not have mandatory rate appeared, the optimal minute ventilation of the patient is means above 250%. Investigators also measure other weaning parameters. Finally, Investigators analyze the prediction of optimal minute ventilation as a weaning parameter.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients are included in this study if they had been maintained on mechanical ventilation in excess of 3 weeks before respiratory care center admission, and all previous weaning attempts had failed. Patients are eligible for respiratory care center admission : hemodynamics stability, no vasoactive drug infusion for 24 hours or more before transfer, stable oxygen requirements(FIO2<40%,PERP<10 cmH2O), no hepatic failure, no requirement for surgical intervention within the 2 weeks, .
Key inclusion criteria (1 listed)
- patients who had been maintained on mechanical ventilation in excess of 3 weeks before respiratory care center admission and all previous weaning attempts had failed.
Key exclusion criteria (1 listed)
- Patients do not have spontaneous breath. Patients do not use invasive mechanical ventilator. Terminal cancer stage and hemodynamics unstable.
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 |
|---|---|---|
| No interventionNo intervention. | Other | – |
Primary outcome
The prediction of optimal minute ventilation as successful weaning parameters in patients with prolong mechanical ventilator.
Time frame: 2016/01/01~2016/12/31,1 year
Investigators observed the condition of patients with adaptive spontaneous ventilation mode that the patient admitted to respiratory care center first day
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 24 Nov 2017.
- Background: PubMed 26026495Ntoumenopoulos G. Rehabilitation during mechanical ventilation: Review of the recent literature. Intensive Crit Care Nurs. 2015 Jun;31(3):125-32. doi: 10.1016/j.iccn.2015.02.001. Epub 2015 May 27.
- Background: PubMed 16354866MacIntyre NR, Epstein SK, Carson S, Scheinhorn D, Christopher K, Muldoon S; National Association for Medical Direction of Respiratory Care. Management of patients requiring prolonged mechanical ventilation: report of a NAMDRC consensus conference. Chest. 2005 Dec;128(6):3937-54. doi: 10.1378/chest.128.6.3937.
- Background: PubMed 18440435King C, Moores LK. Controversies in mechanical ventilation: when should a tracheotomy be placed? Clin Chest Med. 2008 Jun;29(2):253-63, vi. doi: 10.1016/j.ccm.2008.01.002.
- Background: PubMed 8306758Scheinhorn DJ, Artinian BM, Catlin JL. Weaning from prolonged mechanical ventilation. The experience at a regional weaning center. Chest. 1994 Feb;105(2):534-9. doi: 10.1378/chest.105.2.534.
- Background: PubMed 18367735Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.
- Background: PubMed 15699857Frutos-Vivar F, Esteban A. Critical illness polyneuropathy: a new (or old?) reason for weaning failure. Crit Care Med. 2005 Feb;33(2):452-3. doi: 10.1097/01.ccm.0000153525.37281.d4. No abstract available.
- Background: PubMed 20193057Wu YK, Tsai YH, Lan CC, Huang CY, Lee CH, Kao KC, Fu JY. Prolonged mechanical ventilation in a respiratory-care setting: a comparison of outcome between tracheostomized and translaryngeal intubated patients. Crit Care. 2010;14(2):R26. doi: 10.1186/cc8890. Epub 2010 Mar 1.
- Background: PubMed 9333795Schonhofer B. [Effect on the duration of mechanical ventilation of identifying patients capable of breathing spontaneously]. Pneumologie. 1997 Jun;51(6):599-600. No abstract available. German.
- Background: PubMed 22770598Verceles AC, Diaz-Abad M, Geiger-Brown J, Scharf SM. Testing the prognostic value of the rapid shallow breathing index in predicting successful weaning in patients requiring prolonged mechanical ventilation. Heart Lung. 2012 Nov-Dec;41(6):546-52. doi: 10.1016/j.hrtlng.2012.06.003. Epub 2012 Jul 6.
- Background: PubMed 20196884Wu CP, Lin HI, Perng WC, Yang SH, Chen CW, Huang YC, Huang KL. Correlation between the %MinVol setting and work of breathing during adaptive support ventilation in patients with respiratory failure. Respir Care. 2010 Mar;55(3):334-41.
- Background: PubMed 13286206OTIS AB, MCKERROW CB, BARTLETT RA, MEAD J, MCILROY MB, SELVER-STONE NJ, RADFORD EP Jr. Mechanical factors in distribution of pulmonary ventilation. J Appl Physiol. 1956 Jan;8(4):427-43. doi: 10.1152/jappl.1956.8.4.427. No abstract available.
- Individual participant dataSharing planned: No
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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.
YaRu Liang study chair
Taipei Tzuchi hospital , Buddhist Tzu chi medical foundation
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Respiratory Failure, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation.
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 24 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?
The prediction of optimal minute ventilation as successful weaning parameters in patients with prolong mechanical ventilator. (time frame: 2016/01/01~2016/12/31,1 year). 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 NCT03348085, 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 24 Nov 2017.