New Guidelines Published for Discontinuing Mechanical Ventilation in ICU

By Dr Deepu


The American College of Chest Physicians (CHEST) and the American Thoracic Society (ATS) have published new guidelines for discontinuing mechanical ventilation in critically ill adults. The goal of the guidelines is to help physicians and other health care professionals determine when patients with acute respiratory failure can breathe on their own and to provide clinical advice that may increase the chances for successful extubation.

Mechanical ventilation is a life saver, and studies have shown that at any particular moment about 40 percent of all patients in the intensive care unit are breathing with the help of a mechanical ventilator. However, mechanical ventilation can lead to complications, including infections and injury to the lungs and other organs.

Reducing the length of time patients are on mechanical ventilation decreases the risk of these complications, but premature removal from mechanical ventilation can produce other complications and increase mortality.
Based on a systematic review of medical studies, the committee’s recommendations for acutely hospitalized adults on mechanical ventilation for more than 24 hours are:

For patients at high risk for extubation failure who have passed a spontaneous breathing trial (SBT), we recommend extubation to preventative non-invasive ventilation (NIV). The committee found evidence that transitioning to non-invasive ventilation reduced ICU length of stay and short- and long-term mortality. The authors emphasized that in these patients NIV should begin immediately after extubation “to realize the outcome benefits.”
We suggest that the initial SBT be conducted with inspiratory pressure augmentation rather than T-piece or CPAP. The committee wrote that conducting the initial SBT with pressure augmentation was more likely to be successful, produced a higher rate of extubation success and was associated with a trend towards lower ICU mortality.
We suggest protocols attempting to minimize sedation. The committee found that sedation protocols reduced ICU length of stay. However, the protocols did not appear to decrease time on the ventilator or reduce short-term mortality. The authors could not recommend one protocol over another but said the burden of providing sedation by any of the protocols was “very low.”
We suggest protocolized rehabilitation directed toward early mobilization. The committee wrote that patients receiving the intervention spent less time on the ventilator and were more likely to be able to walk when they left the hospital. However, their mortality rate appeared unchanged. The authors noted the exercises created additional work for ICU staff that might have come at the expense of other care priorities.
We suggest managing patients with a ventilator liberation protocol. The committee said that patients managed by protocol spent on average 25 fewer hours on mechanical ventilation and were discharged from the ICU a day early.  However, their mortality rate appeared unchanged.
We suggest performing a cuff leak test in patients who meet extubation criteria and are deemed at high risk for post-extubation stridor. The committee suggested that the test should be used only in patients with a high risk of stridor (abnormal breathing caused by blockage of windpipe) after extubation. Although patients passing the test had lower stridor and reintubation rates, the authors wrote that a high percentage of patients who failed the test could be successfully extubated.
For patients who failed the cuff leak test but are otherwise ready for extubation, we suggest administering systemic steroids at least 4 hours before extubation. The committee said that clinical judgment should take priority over test results, and systemic steroids should be administered to these patients at least 4 hours before extubation. The authors added that the short duration of the steroid therapy was likely to improve success rates without resulting in adverse events.

Download the complete guidelines from here

ICS/LABA exacerbation benefit outweighs pneumonia

By Dr Deepu




The benefit of a fixed-dose inhaled corticosteroid (ICS) and long-acting beta-agonist (LABA) combination in reducing exacerbations of chronic obstructive pulmonary disease (COPD) far outweighed any risk for pneumonia in a post hoc analysis of the 48-week FORWARD study.

Although there were 13 extra pneumonia events when a fixed-dose combination of beclometasone diproprionate and formoterol fumarate (Foster, Chiesi Farmaceutici SpA) was used as compared to formoterol fumarate alone, there were 123 fewer moderate to severe COPD exacerbations over a 342-day analysis period.
The FORWARD study was a two-arm trial designed to compare the efficacy and safety of fixed-dose treatment with beclometasone diproprionate and formoterol fumarate versus formoterol fumarate alone in 1,199 patients with severe COPD.

For inclusion in the study, patients had to have a post-bronchodilator forced expiratory volume in 1 second below 50% of predicted and a forced vital capacity ratio of less than 0.7. They also had to have a smoking history of 10 pack-years or more, and a history of at least one COPD exacerbation in the previous 12 months that had required treatment or hospitalization (Eur RespirJ. 2013;41[1]:12-7).

After a 2-week run-in period, where all patients received a 24-mcg dose of formoterol fumarate, patients were randomized to continue treatment with formoterol fumarate or to receive the fixed-dose combination of beclometasone diproprionate 400 mcg and beclometasone diproprionate 24 mcg for 48 weeks.

A total of 1,186 patients, most of whom were male (69%) with a mean age of 64 years, formed the intention-to-treat population.

Published results (Respir Med. 2014;108[8]:1153-62) showed that the combination of the ICS beclometasone diproprionate and the LABA formoterol fumarate (Chiesi Farmaceutici SpA) was associated with a 28% reduction in the annual rate of moderate to severe exacerbations versus the LABA alone.

The adjusted rate of exacerbations per patient per year was 0.80 in patients treated with the ICS/LABA combination versus 1.12 for those treated with just the LABA, with an adjusted rate ratio of 0.72 (P less than .001).

The published data also showed that pneumonia was reported by 23 patients (3.8%) treated with the ICS/LABA and by 11 (1.8%) treated with the LABA only.

For the new analysis,  pneumonia and COPD exacerbations were looked in more detail, plotting out the cumulative number of events over time and also characterizing the types of pneumonia in more detail.

All patients had a chest x-ray to confirm the presence of pneumonia, he said, there were 35 cases of pneumonia, 24 occurring in patients treated with the fixed-dose beclometasone diproprionate and formoterol fumarate combination and 11 in patients treated only with formoterol fumarate.

Of these cases, 25 required in-hospital treatment – 16 patients in the ICS/LABA arm and 9 in the LABA-only arm. There were three instances of patients acquiring pneumonia in hospital – two in the ICS/LABA and one in the LABA-only arm.

There were also two fatal cases of pneumonia – one in each treatment group. Neither were thought to be related to either of the treatments.

These findings are in line with a recent review of the use of ICS for COPD by the European Medicines Agency (EMA/488280/2016), which noted that “overall the benefits of inhaled corticosteroid medicines in treating COPD continue to outweigh their risks and there should be no change to the way in which these medicines are used.”

The European Medicines Agency advised that patients and clinicians need to “be alert for signs and symptoms of pneumonia, bearing in mind that the clinical features of pneumonia overlap with those of a worsening (exacerbation) of the underlying disease.”

Results of IMPULSIS on extension trial released.

By Dr Deepu



The interim findings from the INPULSIS-ON extension trial were presented at the European Respiratory Society (ERS) International Congress 2016 in London.



The findings were consistent with those previously reported from the INPULSIS Phase 3 trials (INPULSIS-1 and -2). The interim analysis from the extension trial demonstrated that nintedanib slows disease progression in IPF patients. In addition, long-term treatment with nintedanib  (up to 51 months) was associated with manageable side effects in most patients, with diarrhea being the most frequently reported side effect.

Results from the interim analysis of INPULSIS-ON demonstrated that in terms of forced vital capacity (FVC, a measure of lung function) in IPF patients who continued nintedanib treatment in the extension trial, the change between baseline and week 48 and between weeks 48 and 96 was similar to what was seen in IPF patients who were on active treatment with Ofev in the 52-week INPULSIS clinical trials.

Findings from the trials on the effect of nintedanib on FVC demonstrated that:

In INPULSIS, the mean FVC change from baseline to week 52 was −89mL compared to –203mL for placebo-treated patients;
In INPULSIS-ON, the mean FVC change for patients who continued treatment was −96 mL from baseline to week 48;
In INPULSIS-ON, the mean FVC change for patients who continued treatment was −124mL from week 48 to week 96;
In INPULSIS and INPULSIS-ON, the average exposure to Ofev was around three years (35.7 months).
Two additional sub-group analyses from the trials revealed that treatment with Ofev has a beneficial effect on the annual rate of FVC decline regardless of the patients’ baseline lung impairment, providing additional evidence of the benefits of the drug in slowing disease progression in a range of IPF patients.

nintedanib is a small molecule tyrosine kinase inhibitor, which has been approved and marketed globally for treating IPF in adults. nintedanib blocks multiple signaling pathways that may be involved in the scarring of lung tissue and fibrotic processes, reducing disease progression in IPF and slowing lung function decline.

Trial indicates Ofev slows progression in IPF patients

By Dr Deepu



The interim findings from the INPULSIS-ON extension trial were presented at the European Respiratory Society (ERS) International Congress 2016 in London.


The findings were consistent with those previously reported from the INPULSIS Phase 3 trials (INPULSIS-1 and -2). The interim analysis from the extension trial demonstrated that nintedanib slows disease progression in IPF patients. In addition, long-term treatment with nintedanib  (up to 51 months) was associated with manageable side effects in most patients, with diarrhea being the most frequently reported side effect.

Results from the interim analysis of INPULSIS-ON demonstrated that in terms of forced vital capacity (FVC, a measure of lung function) in IPF patients who continued nintedanib treatment in the extension trial, the change between baseline and week 48 and between weeks 48 and 96 was similar to what was seen in IPF patients who were on active treatment with Ofev in the 52-week INPULSIS clinical trials.

Findings from the trials on the effect of nintedanib on FVC demonstrated that:

In INPULSIS, the mean FVC change from baseline to week 52 was −89mL compared to –203mL for placebo-treated patients;
In INPULSIS-ON, the mean FVC change for patients who continued treatment was −96 mL from baseline to week 48;
In INPULSIS-ON, the mean FVC change for patients who continued treatment was −124mL from week 48 to week 96;
In INPULSIS and INPULSIS-ON, the average exposure to Ofev was around three years (35.7 months).
Two additional sub-group analyses from the trials revealed that treatment with Ofev has a beneficial effect on the annual rate of FVC decline regardless of the patients’ baseline lung impairment, providing additional evidence of the benefits of the drug in slowing disease progression in a range of IPF patients.

nintedanib is a small molecule tyrosine kinase inhibitor, which has been approved and marketed globally for treating IPF in adults. nintedanib blocks multiple signaling pathways that may be involved in the scarring of lung tissue and fibrotic processes, reducing disease progression in IPF and slowing lung function decline.

Add-on Tiotropium Therapy Improves Asthma

By Dr Deepu

At least 40% of asthma patients remain symptomatic despite treatment with inhaled corticosteroids with or without long-acting β2-agonists. The long-acting anticholinergic bronchodilator tiotropium (Spiriva Respimat/Boehringer Ingelheim) has been incorporated into the Global Initiative for Asthma 2015 treatment strategy as an add-on therapy option for patients with a history of asthma exacerbations, and the clinical efficacy and safety of add-on tiotropium therapy have been established in adults across differing asthma severity levels.

Now, two randomized, double-blind, parallel-group twin trials reported in Respiratory Medicine have shown that add-on tiotropium therapy helps to control asthma in symptomatic patients regardless of many patient characteristics. These findings indicate that add-on tiotropium therapy could be useful for a wide range of asthma patients who still have asthma symptoms despite treatment with other agents.

In these two international, multicenter trials, add-on therapy with tiotropium improved lung function and asthma symptom control and reduced the risk of asthma exacerbation episodes and worsening of asthma in symptomatic asthma patients taking an inhaled corticosteroid with a long-acting β2-agonist, regardless of patient age, allergic status, and degree of airway obstruction at baseline.

The trials enrolled 912 patients with severe, symptomatic asthma who had been taking at least 800 μg of budesonide or the equivalent as well as a long-acting β2-agonist for at least 4 weeks. Currently symptomatic patients between the ages of 18 and 75 years with a history of asthma of at least 5 years and an initial diagnosis before age 40 years were eligible to participate in the study. Moderate or persistent airflow limitation at the initial screening visit and at least one exacerbation in the last year requiring systemic glucocorticoid therapy were also requirements for study participation.

Patients were randomly assigned in a 1:1 ratio to receive either tiotropium, 5 μg once daily via the Respimat Soft Mist inhaler (Boehringer Ingelheim), or placebo for 48 weeks.

The study investigators measured the following asthma parameters:
Peak force expiratory volume in 1 second (FEV1)
Trough FEV1
Time to first severe exacerbation
Time to first episode of worsening asthma
Results from the seven-question Asthma Control Questionnaire
Subgroup analysis of the relation between these parameters and patients’ baseline characteristics indicated that, compared with placebo, once-daily  tiotropium improved lung function and control of asthma in these patients independently of a broad range of characteristics including gender, body mass index, disease duration, age at asthma onset, FEV1 percentage predicted at screening, and FEV1 reversibility.

The cervical rib

By Dr Deepu







A cervical rib in humans is a supernumerary (or extra) rib which arises from the seventh cervical vertebra. Sometimes known as "neck ribs", their presence is a congenital abnormality located above the normal first rib. A cervical rib is estimated to occur in 0.6% (1 in 150 people) to 0.8% of the population. People may have a cervical rib on the right, left or both sides.

Most cases of cervical ribs are not clinically relevant and do not have symptoms; cervical ribs are generally discovered incidentally. However, they vary widely in size and shape, and in rare cases, they may cause problems such as contributing to thoracic outlet syndrome, because of pressure on the nerves that may be caused by the presence of the rib.

A cervical rib represents a persistent ossification of the C7 lateral costal element. During early development, this ossified costal element typically becomes re-absorbed. Failure of this process results in a variably elongated transverse process or complete rib that can be anteriorly fused with the T1 first rib below.

On imaging, cervical ribs can be distinguished because their transverse processes are directed inferolaterally, whereas those of the adjacent thoracic spine are directed anterolaterally.

Associated conditions

The presence of a cervical rib can cause a form of thoracic outlet syndrome due to compression of the lower trunk of the brachial plexus or subclavian artery. These structures become encroached upon by the cervical rib and scalene muscles. Compression of the brachial plexus may be identified by weakness of the muscles around the muscles in the hand, near the base of the thumb. Compression of the subclavian artery is often diagnosed by finding a positive Adson's sign on examination, where the radial pulse in the arm is lost during abduction and external rotation of the shoulder. A positive Adson's sign is non-specific for the presence of a cervical rib however, as many individuals without a cervical rib will have a positive test.




Spotter: Is this X ray Normal???

By Dr Deepu



See the answer here

Important chest radiology signs.

By Dr Arun M, MD (Respiratory Medicine).
 Faculty in department of medicine, KMC Mangalore.
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