Early self-proning in awake, non-intubated patients in the ED: A single ED’s Experience during the COVID-19 pandemic

This pilot study was carried out at the crazy Lincoln Medical Center, New York City. Located in the Bronx, it is the third busiest ED in the United States. In the grips of a pandemic, it is the perfect place to study potential treatments of COVID-19.

Awake proning has been shown to be beneficial in patients with ARDS and anecdotal reports have suggested it may be helpful for patients with coronavirus.

This pilot study enrolled a convenience sample of 50 patients who presented to their ED with hypoxia without resolution despite supplemental oxygen and who were capable of self-proning. They excluded patients who were NFR, getting NIV or intubated in the prehospital setting. All were eventually confirmed as COVID positive.

They termed these patients the “happy hypoxemics” as they generally looked quite well without respiratory distress despite having low oxygen saturation.

Results?

The median SpO2 at triage was 80% and this improved to 84% with supplemental oxygen. After 5 minutes of proning the saturation increased to 94%!

18 of the 50 patients eventually required intubation; 13 of those (24%) within the first 24 hours.

This pilot study has lots of limitations; no control group, no idea if proning resulted in meaningful patient-oriented outcomes. Nevertheless, it has adequately raised the hypothesis for a clinical trial.  A search of www.clinicaltrials.gov shows there are now several in progress.

Could there be harm from self-proning? It is possible. But these authors recommend proning until we get better quality evidence to inform practice. They have typical protocols whereby patients are asked to rotate about every 30 to 120 minutes.

Proning support cushions are already being sold in the USA. You can get one for US$164! I would not be surprised if a device manufacturer comes out with a human rotisserie device. No joke… watch this space!

Covering:

Caputo ND, Strayer R, Levitan R. Early Self-Proning in Awake, Non-intubated Patients in the Emergency Department: A Single ED’s Experience during the COVID-19 Pandemic. Acad Emerg Med. 2020;27(5):375-378 [link to full text article]

Intranasal ketamine for analgesia prior to digital nerve block- A double blind RCT!!??

Wow…

This was reportedly a double blind RCT of intranasal ketamine 50mg vs. saline placebo prior to performance of digital nerve blocks at a single centre in Iran. All the blocks were done by one doctor (listed as the third out of seven authors).

The primary outcome was reduction of pain during the block as measured on a visual analogue scale (VAS).

Results?

Exactly 100 patients were enrolled. Block pain was less in the group that got IN ketamine 28mm vs. 47mm (P less than 0.001) on the VAS. Side effects were reported to be “trivial.” This pain reduction persisted at the 45-minute mark at 21mm vs 43mm (P less than 0.001).

The authors conclude, “… IN Ketamine can be effective in reducing pain in patients with acute pain, without adding significant side effects.”

I doubt that many of us would consider giving ketamine prior to a digital nerve block. It does seem rather excessive and puts the patient at risk of side effects. (Reminds me of propofol for migraine) Perhaps we might consider inhaled nitrous oxide or intranasal fentanyl?

Unfortunately, there are a few problems and red flags with this study.

• The final study methods differ quite substantially from those listed in the trial registry found here.  The primary outcome was different, no power calculation, measuring tool different, etc.
• Intranasal ketamine burns and tastes bad. This could have unmasked blinding resulting in measurement bias.
• Data was collected in 2014. Why did it take 5 years to get published? I’m guessing it was rejected for publication from numerous journals.
• In the manuscript, there are numerous grammatical and spelling errors. What does a sloppy manuscript say about the conduct of the study?
• Why did patients continue to report substantial pain after the nerve block? Most of these blocks should have been successful at complete analgesia.
• Side effects were likely under-reported

Regardless of this study's conduct or limitations, I’m not a big fan of intranasal ketamine. Not great bang-for-buck and an undesirable side effect profile. In addition, we have experience with other drugs that are more efficacious.

Covering

Nejati A, Jalili M, Abbasi S, et al. Intranasal ketamine reduces pain of digital nerve block; a double blind randomized clinical trial. Am J Emer Med. 2019;27:1622-1626.

Targeted Temperature Management for Cardiac Arrest with Nonshockable Rhythm

The literature regarding cooling of comatose survivors of cardiac arrest is mixed. But even more controversial is the role of therapeutic hypothermia in the group of patients with non-shockable rhythm.

Enter the HYPERION trial published in the high impact New England Journal of Medicine.

This mammoth effort was an open-label pragmatic RCT comparing hypothermia (33 degrees) vs normothermia (37 degrees) in comatose survivors of cardiac arrest with non-shockable rhythms (PEA or asystole).

As if PEA and asystole were not bad enough, they excluded the sicker patients who would have highly likely died anyway- regardless of cooling or no cooling. These were patients who had no CPR for >10 minutes, CPR for more than 60 minutes, those with high vasopressor requirements etc.

The primary outcome was a good one; survival with a favorable day-90 neurologic outcome. This was defined as independent & able to perform ADL’s (CPC score 1-2). Unfortunately, it was possibly poorly determined by a single blinded psychologist by phone interview.

Results?

Over 4 years, 581 patients were included from 25 French ICU’s. On day 90, 10.2% of the hypothermia group vs. 5.7% of the normothermia had a good outcome (difference 4.5% 95%CI 0.1 to 8.9; P=0.04 and a NNT of 22.) Overall mortality did not differ between the groups at 80%.

Cooling wins!?

Despite the results, I am a bit less enthusiastic about this one.

The literature is still conflicting, and this is far from overwhelming data.

The primary result has a fragility index of 1. If only one of the patients that did well in the hypothermia group were reclassified as unfavorable at 90 days, the results would not have been statistically significant… we would be talking about a negative trial.

There are other issues with the measurement of the primary outcome, external validity and a few other things.

In the end, it is probably fine if your ICU wants to cool these patients. But please make sure it does not distract & get in the way of providing adequate resuscitation and supportive care. Stay cool (or not) and do the right things first.

Covering:

Lascarrou JB, Merdji H, Le Gouge, A, et al. Targeted Temperature Management for Cardiac Arrest with Non-Shockable Rhythm. New Engl J Med; 2019: 381:2327-2337. [link to article]