AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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.

Iran1 site
  • Shariati hospital, Mousavi Hospital, Valiasr hospital

    Tehran & Zanjan

Other trials in Iran

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

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.

  1. Better accuracy in predicting weaning outcome

    Measured: Four years

Secondary outcomes (1)
  1. Adequate prognosis

    The following measurements were taken for weaning indexes:

    1. RSBI
    2. NIF
    3. P0.1
    4. CROP
    5. IWI
    6. PaO2: PALVO2 ration (PPR)
    7. PaO2:FiO2 ratio (PFR)
    8. RR
    9. VT
    10. MV
    11. C Dynamic
    12. C Static
    13. Pimax
    14. PaO2
    15. PaCO2
    16. FiO2
    17. SaO2
    18. Respiratory index
    19. Formula one [(PPR)/ (RSBI*FiO2)]
    20. Formula two [(PPR)/ (RSBI*FiO2*P0.1)]
    21. Formula three [(PPR)*(NIF)/ (RSBI*FiO2)]
    22. Formula four [(PPR)*(NIF)/ (RSBI*FiO2*P0.1)]
    23. Formula five [(NIF)/ (P0.1)]
    24. Formula six [(SaO2)/ ((P (A-a) O2)*RSBI*FiO2)]
    25. Formula seven [(SaO2)/ ((P (A-a) O2)*RSBI*FiO2*P0.1)]
    26. Formula eight [(SaO2*NIF)/ ((P (A-a) O2)*RSBI*FiO2)]
    27. Formula nine [(SaO2*NIF)/ ((P (A-a) O2)*RSBI*FiO2*P0.1)]
    28. 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.

  1. First posted30 Jan 2013 (estimated)
  2. Study startOct 2007
  3. Primary completionJan 2008
  4. Study completionDec 2012

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in