Mechanical Ventilation WeaningNIWIsNCT01779297
New Integrated Weaning Indexes
An observational study of Mechanical Ventilation Weaning, run by Baqiyatallah Medical Sciences University at 1 site in Iran.
Trial summary
The purpose of this study is to determine whether introducing the new weaning indexes can predict better than traditional ones? Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Mechanical Ventilation Weaning
- How many people
- 1,175 participants
- Where
- 1 siteIran
- Study dates
- Oct 2007to Dec 2012
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: One thousand one hundred and seventy-five patients who were on mechanical ventilation for more than 24 hours were evaluated.
Who may be able to join
- Patients (both males and females) more than 24 hours in mechanical ventilation in weaning process.
Who cannot join
- Hypercapnic respiratory failure attributable to COPD exacerbation or post-respiratory arrest;
- underlying moderate to severe obstructive airways disease, defined as forced expiratory volume in 1 second of < 50% of predicted value, or baseline PaCO2 > 50 mmHg,
- concurrent neurological and neuromuscular or drug intoxication contributing to respiratory failure; and finally younger than 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: New Integrated Weaning Indexes From Mechanical Ventilation: A Prospective Clinical Trial
The purpose of this study is to determine whether introducing the new weaning indexes can predict better than traditional ones?
Read the detailed description
The study was divided into two parts: First, the threshold values of the indexes that discriminated best between successful weaning and weaning failure were determined in training set (n = 208). Second, the accuracy of each index was scrutinized prospectively in an additional group of patients (prospective-validation data set, n = 967). One thousand one hundred and seventy-five patients who were on mechanical ventilation for more than 24 hours were evaluated.Informed consent was obtained from each patient, whenever possible, or from the patient's next of kin. The samples were selected using a simple random sampling method in which the entry number of eligible patients was considered to be the sampling ID number. Using Random Allocation Software (RAS), random numbers were generated to select the study participant.
The ventilators used were Evita XL and Evita 4 edition (Draeger, Lubeck, Germany).
According to a protocol that have introduced in two studies, the protocol established. All of the mechanically ventilated patients undergoing assessment for extubation undergo a daily SBT if predetermined eligibility criteria for weaning are met . According to this protocol, sedation would be discontinued before evaluation of weaning. Patients who meet these criteria are initially placed on SBT (continuous positive airway pressure of 5 mmHg, FiO2≤0.4) for 3 minutes to obtain weaning parameters. If the Oxygen saturation is ≥ 92% on pulse oximetry with FiO2≤0.4 and RSBI <104 breaths/minute/L, patients are continued on the SBT for 30 to 120 minutes. All clinical and ventilator parameters are monitored closely for signs of respiratory distress (respiratory rate > 30 breaths/minute, SaO2< 90%, heart rate > 140 breaths/minute, or a sustained increase or decrease of heart rate of >20%, blood pressure>200 mm Hg or <80 mm Hg, and agitation, diaphoresis, or anxiety). At the end of the SBT, the RSBI is measured again, ABG is obtained, and the predetermined values are calculated and measured. The decision to return to mechanical ventilation made by the two subspecialists in pulmonary and lung diseases, who were chief supervisor of both ICU in two cities (who were completely blind to the study and the results of the indexes evaluated), based on airway competence (cough, sputum production, neurologic status, level of consciousness, and maximal inspiratory pressure). Patients who remain extubated at 48 hours are classified as having had a successful extubation. Baseline demographics, initial diagnosis, and pre-extubation clinical, ventilator, laboratory, and radiographic data are collected for each patient.
To assess the prognostic value of new indices, receiver operator characteristic (ROC) curves was drawn for each formula in addition for other conventional criteria used in this area. For each ROC curve analysis, sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value, diagnostic accuracy, likelihood ratio of a positive test (LR+) and the likelihood ratio of a negative test (LR-), probability for weaning success when test is positive and probability for weaning success when test is negative of the indexes were used to predict the weaning outcome in the prospective-validation data set.
Hanley and McNeil method was used to calculate the area under curve (AUC) for each formula and then the methods developed by the same authors were used to compare these AUCs. Bayes' theorem was used to compute the weaning outcome the probability for weaning success when test is positive and negative (post-test probability) in the prospective-validation data set to assess the perform
- Conditions
- Mechanical Ventilation Weaning
- Keywords
- new integrative weaning indexes, mechanical ventilation, ICU
What is being measured
The primary outcome is the main question the study is designed to answer.
Better accuracy in predicting weaning outcome
Measured: Four years
Secondary outcomes (1)
Adequate prognosis
The following measurements were taken for weaning indexes:
- RSBI
- NIF
- P0.1
- CROP
- IWI
- PaO2: PALVO2 ration (PPR)
- PaO2:FiO2 ratio (PFR)
- RR
- VT
- MV
- C Dynamic
- C Static
- Pimax
- PaO2
- PaCO2
- FiO2
- SaO2
- Respiratory index
- Formula one [(PPR)/ (RSBI*FiO2)]
- Formula two [(PPR)/ (RSBI*FiO2*P0.1)]
- Formula three [(PPR)*(NIF)/ (RSBI*FiO2)]
- Formula four [(PPR)*(NIF)/ (RSBI*FiO2*P0.1)]
- Formula five [(NIF)/ (P0.1)]
- Formula six [(SaO2)/ ((P (A-a) O2)*RSBI*FiO2)]
- Formula seven [(SaO2)/ ((P (A-a) O2)*RSBI*FiO2*P0.1)]
- Formula eight [(SaO2*NIF)/ ((P (A-a) O2)*RSBI*FiO2)]
- Formula nine [(SaO2*NIF)/ ((P (A-a) O2)*RSBI*FiO2*P0.1)]
- Formula ten [(SaO2)/ ((P (A-a) O2)*P0.1)] These are newly proposed indexes, used in some hospitals in Iran.
Measured: Four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startOct 2007
- Primary completionJan 2008
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation WeaningStudies 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
- 1,175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baqiyatallah Medical Sciences University
- Sponsor type
- University, hospital or other
- Collaborators
- Tehran University of Medical Sciences
- Responsible party
- Principal investigator, Amir Vahedian-Azimi, Baqiyatallah Medical Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779297
- Sponsor's protocol ID
- BMSU & TUMS
- Acronym
- NIWIs
- Status last verified
- Jan 2013
- First submitted
- 23 Jan 2013
- Last updated
- 30 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Integrated Weaning Indexes From Mechanical Ventilation: A Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT01779297
- Acronym / sponsor ID
- NIWIs / BMSU & TUMS
- Conditions
- Mechanical Ventilation Weaning
- Keywords
- new integrative weaning indexes, mechanical ventilation, ICU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,175 participants (actual)
- Lead sponsor
- Baqiyatallah Medical Sciences UniversityUniversity, hospital or other
- Collaborators
- Tehran University of Medical Sciences
- Study start
- Oct 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Jan 2013 (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.
The purpose of this study is to determine whether introducing the new weaning indexes can predict better than traditional ones?
Detailed description
The study was divided into two parts: First, the threshold values of the indexes that discriminated best between successful weaning and weaning failure were determined in training set (n = 208). Second, the accuracy of each index was scrutinized prospectively in an additional group of patients (prospective-validation data set, n = 967). One thousand one hundred and seventy-five patients who were on mechanical ventilation for more than 24 hours were evaluated.Informed consent was obtained from each patient, whenever possible, or from the patient's next of kin. The samples were selected using a simple random sampling method in which the entry number of eligible patients was considered to be the sampling ID number. Using Random Allocation Software (RAS), random numbers were generated to select the study participant.
The ventilators used were Evita XL and Evita 4 edition (Draeger, Lubeck, Germany).
According to a protocol that have introduced in two studies, the protocol established. All of the mechanically ventilated patients undergoing assessment for extubation undergo a daily SBT if predetermined eligibility criteria for weaning are met . According to this protocol, sedation would be discontinued before evaluation of weaning. Patients who meet these criteria are initially placed on SBT (continuous positive airway pressure of 5 mmHg, FiO2≤0.4) for 3 minutes to obtain weaning parameters. If the Oxygen saturation is ≥ 92% on pulse oximetry with FiO2≤0.4 and RSBI <104 breaths/minute/L, patients are continued on the SBT for 30 to 120 minutes. All clinical and ventilator parameters are monitored closely for signs of respiratory distress (respiratory rate > 30 breaths/minute, SaO2< 90%, heart rate > 140 breaths/minute, or a sustained increase or decrease of heart rate of >20%, blood pressure>200 mm Hg or <80 mm Hg, and agitation, diaphoresis, or anxiety). At the end of the SBT, the RSBI is measured again, ABG is obtained, and the predetermined values are calculated and measured. The decision to return to mechanical ventilation made by the two subspecialists in pulmonary and lung diseases, who were chief supervisor of both ICU in two cities (who were completely blind to the study and the results of the indexes evaluated), based on airway competence (cough, sputum production, neurologic status, level of consciousness, and maximal inspiratory pressure). Patients who remain extubated at 48 hours are classified as having had a successful extubation. Baseline demographics, initial diagnosis, and pre-extubation clinical, ventilator, laboratory, and radiographic data are collected for each patient.
To assess the prognostic value of new indices, receiver operator characteristic (ROC) curves was drawn for each formula in addition for other conventional criteria used in this area. For each ROC curve analysis, sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value, diagnostic accuracy, likelihood ratio of a positive test (LR+) and the likelihood ratio of a negative test (LR-), probability for weaning success when test is positive and probability for weaning success when test is negative of the indexes were used to predict the weaning outcome in the prospective-validation data set.
Hanley and McNeil method was used to calculate the area under curve (AUC) for each formula and then the methods developed by the same authors were used to compare these AUCs. Bayes' theorem was used to compute the weaning outcome the probability for weaning success when test is positive and negative (post-test probability) in the prospective-validation data set to assess the perform
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- One thousand one hundred and seventy-five patients who were on mechanical ventilation for more than 24 hours were evaluated.
Key inclusion criteria (1 listed)
- Patients (both males and females) more than 24 hours in mechanical ventilation in weaning process.
Key exclusion criteria (3 listed)
- Hypercapnic respiratory failure attributable to COPD exacerbation or post-respiratory arrest;
- underlying moderate to severe obstructive airways disease, defined as forced expiratory volume in 1 second of < 50% of predicted value, or baseline PaCO2 > 50 mmHg,
- concurrent neurological and neuromuscular or drug intoxication contributing to respiratory failure; and finally younger than 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Better accuracy in predicting weaning outcome
Time frame: Four years
1 secondary outcome
Adequate prognosis
Time frame: Four years
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 30 Jan 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation Weaning, run by Baqiyatallah Medical Sciences University at 1 site in Iran.
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 3 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 30 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Better accuracy in predicting weaning outcome (time frame: Four years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2013.