Tucked In: Weighted Blankets to Improve Sleep in Intensive Care Unit Patients
December 14, 2021- 00:00Hi everyone, my name is Jamie.
- 00:03Thank you all for being here.
- 00:04It's so nice to see you all in person
- 00:06and thank you for everyone who's
- 00:08tuning in online and also special
- 00:11thanks to my advisor Doctor Nauert.
- 00:13So my topic is tucked in weighted
- 00:16blankets to improve sleep in
- 00:18intensive care unit patients and I
- 00:20did the traditional thesis group.
- 00:22So just a quick outline of what
- 00:25will be going through today.
- 00:27So sleep in all people,
- 00:29but especially those in the critically ill,
- 00:32is incredibly important.
- 00:33Those in the intensive care unit
- 00:35have been found to have all domains
- 00:38of sleep deficiency that would
- 00:40include abnormal sleep timing,
- 00:41poor sleep quality, or short sleep duration.
- 00:45Sleep deficiency can increase the risk
- 00:48of infectious and inflammatory diseases,
- 00:50and it has contributions to all 'cause
- 00:53mortality and it shows that there
- 00:55are implications up to 12 months.
- 00:57After both physically and
- 01:01psychologically with PTSD.
- 01:03As far as measuring sleep goes,
- 01:05there are two ways to go about it.
- 01:07There are objective measures,
- 01:09which is polysomnography or PSG,
- 01:11the gold standard.
- 01:12This is a high cost and
- 01:15uncomfortable process.
- 01:17It requires a lot of wires or leads
- 01:20EKG EG on the head it tracks eye
- 01:24movements and patients already bogged
- 01:26down with a lot of Ivs and other wires
- 01:31and it overall just doesn't bode well.
- 01:34For a good study, however,
- 01:36there's actigraphy.
- 01:37It has a significant correlation,
- 01:39shown in studies with PSG,
- 01:41it's less invasive, less cumbersome,
- 01:43more cost efficient.
- 01:44It's essentially what we like
- 01:46to say is a glorified Fitbit.
- 01:48You wear it on your wrist,
- 01:50and it can track your total sleep time.
- 01:53Another way of going about measuring
- 01:54sleep is a subjective measure.
- 01:56The Richard Campbell Sleep
- 01:58Questionnaire is the only validated
- 02:01questionnaire for ICU patients.
- 02:03It's significantly.
- 02:04Has been found to correlate
- 02:06with PSG measures.
- 02:08It requires just a simple tickmark by
- 02:10patients and that are critically ill,
- 02:12so this works well for them.
- 02:14They have low stamina,
- 02:15it just requires a simple tick
- 02:18mark on a visual analog scale.
- 02:20So many ways have been trial
- 02:23to enhance sleep,
- 02:24especially in the critically ill,
- 02:27but there's no evidence based
- 02:30pharmacological interventions available.
- 02:32Oftentimes, if we try to use
- 02:34pharmacological methods or adverse effects,
- 02:36and there can also be drug,
- 02:37drug interactions,
- 02:38and patients that are already enduring
- 02:41a large pharmacological burden.
- 02:43Normal non pharmacological interventions
- 02:45have been tried and they show some promise.
- 02:48Some things like ear plugs,
- 02:49eye masks, music.
- 02:50Cluster nursing care specifically,
- 02:52is when nurses tried to do their
- 02:54best to do all their tasks at once
- 02:57when entering a room instead of
- 02:58going in multiple times specifically
- 03:00at Yale and the medical ICU,
- 03:03they have the standard of care,
- 03:05which is a quiet time from midnight
- 03:07to 4:00 AM and a quiet pack which
- 03:10is given to all patients and
- 03:12includes an eye mask and ear buds.
- 03:14Despite all these interventions
- 03:15that are tried consistently,
- 03:17patients report for sleep,
- 03:18whether it's at Yale or another
- 03:20hospital and for this.
- 03:21Reason it's necessary to continue
- 03:23to evaluate more methods.
- 03:26Then comes weighted blankets,
- 03:28blankets of various sizes that are filled
- 03:31with different materials to evenly
- 03:33distribute the weight across a body.
- 03:36The theoretical framework is
- 03:38that it's deep touch pressure.
- 03:40It's almost like a hug
- 03:43or a swaddle for a baby,
- 03:45and they're ideally 10% of your
- 03:47body weight and they can be
- 03:48manufactured in such a way that
- 03:50they can be wiped down with wipes,
- 03:52which would be helpful in an
- 03:54intensive care unit setting they've
- 03:55been studied in many populations.
- 03:57They've been studied in
- 03:59adult psychiatric centers,
- 04:00children with autism neonates in the ICU,
- 04:04those with breast cancer in
- 04:07inpatient and outpatient settings.
- 04:09These studies have often been flawed
- 04:11in certain ways or have not had
- 04:14significant sample sizes show bias,
- 04:17but overall results have showed an
- 04:19increase in total sleep time and
- 04:22consistently show a high user satisfaction.
- 04:24However, weighted blankets have not
- 04:26been tried in the critically ill.
- 04:29So as far as the problem goes,
- 04:32sleep deficiency is pervasive
- 04:33in the critically ill,
- 04:34with no evidence based pharmacological
- 04:37interventions shown to be effective.
- 04:39For this reason,
- 04:40non pharmacological strategies
- 04:41must be continued to be explored.
- 04:44Weighted blankets have been shown
- 04:45to help with sleep and anxiety in a
- 04:47variety of settings and populations.
- 04:49However,
- 04:49there's a lack of literature
- 04:52in this population where sleep
- 04:54is vital and jeopardized.
- 04:56So we hypothesize that weighted
- 04:57blankets used in hospital lies patients
- 05:00over 50 years old in intensive care
- 05:02units will have different mean
- 05:04total sleep time when compared to
- 05:06baseline of those with usual care.
- 05:10This will be a randomized controlled trial.
- 05:12It will have two arms,
- 05:14weighted blankets and usual
- 05:15or standard of care.
- 05:17We will study adult critically
- 05:19ill patients over 50 years old.
- 05:21The reason we specify 50 years old
- 05:23is that they are most susceptible
- 05:25to the adverse effects of low sleep,
- 05:27including things like delirium,
- 05:28which is rampant in the ICU.
- 05:31The exclusion criteria will include
- 05:32those in respiratory failure,
- 05:34so those on, say,
- 05:35a ventilator or those with active loans,
- 05:37whether they're pressure wounds
- 05:39or recent surgeries.
- 05:40And those expected to leave within
- 05:42the next 24 hours by staff.
- 05:44We will evaluate all patients
- 05:46admitted to the MCU daily as
- 05:48potential subjects for this study.
- 05:53The key variables the intervention will
- 05:55be the weighted blanket plus standard of
- 05:57care and like I mentioned earlier at Yale,
- 05:59the standard of care is that
- 06:01quiet pack in those quiet hours,
- 06:03the control will be standard of care alone.
- 06:05The primary outcome will be total sleep
- 06:08time via actigraphy that glorified Fitbit.
- 06:11On night two of the blanket use and
- 06:13the secondary outcome will be the
- 06:14Sleep Questionnaire the next morning.
- 06:16Based on that night,
- 06:17two of the study we will come.
- 06:20Get consent from all patients to videotape
- 06:23to ensure that the blanket is used
- 06:25for at least one hour on that night.
- 06:28Two of the study and only those
- 06:30that use the blanket for one hour
- 06:33will qualify for analysis.
- 06:34Blinding the intervention
- 06:35to the participants.
- 06:37We will phrase it as a non pharmacological
- 06:40sleep study and we will leave out
- 06:42the fact that the intervention of
- 06:44interest is the way to blanket because
- 06:46standard of care as well also has
- 06:49non pharmacological interventions,
- 06:51the ear buds.
- 06:52And the eye mask.
- 06:54Finding the outcome.
- 06:55The research assistant
- 06:56interpreting the data will not
- 06:58have access to the allocation.
- 07:01So yells, MCU admits 4000 patients per year,
- 07:05and the median stays three nights,
- 07:08which allows us to determine that this would
- 07:10be a feasible study to carry out at Yale.
- 07:13We calculated the sample size based on data
- 07:17historical data in the Yale ICU based on Dr.
- 07:20Narcs lab. They found that the average
- 07:22is 94 minutes of total sleep time with
- 07:25variance of 61 minutes willpower.
- 07:27The study to 80% affect size
- 07:29of 20% or 18 minutes.
- 07:31So given all this data,
- 07:33historical data based on Doctor Notes Lab,
- 07:37we will have a calculated sample
- 07:39size of 324 and will round up to
- 07:413:30 to allow for correction.
- 07:45So this is just a graphic
- 07:47kind of outlying everything.
- 07:49I already said patients will be admitted
- 07:52to the hospital later admitted to the MCU.
- 07:56They'll be randomized either
- 07:57to control or intervention,
- 07:59and they'll wear actigraphy on night one,
- 08:01though the night of interest is night two,
- 08:03once they're accustomed to all of
- 08:05these things being on their body,
- 08:06and they've adjusted to being on the unit,
- 08:09so night two will collect
- 08:11the actigraphy data,
- 08:12and the next morning will do
- 08:14the Sleep questionnaire.
- 08:15Based on night, two of the study.
- 08:19So. The impact that this
- 08:21could have is that it could.
- 08:23Improve patient outcomes both short term
- 08:25and long term like I'd mentioned earlier,
- 08:28these effects of low sleep can carry
- 08:30on up to 12 months after discharge.
- 08:33It allows us to offer another non
- 08:37pharmacological option to those
- 08:39that don't have many options and it
- 08:43can increase patient satisfaction.
- 08:44It avoids secondary harm and not trying
- 08:48to treat pharmacologically and while
- 08:51it is a very specific population.
- 08:54It's a population where sleep
- 08:55is most disrupted,
- 08:56and ideally we would be able to generalize
- 08:59and apply to a wider population.
- 09:03Uhm, the study has some potential strengths.
- 09:06It's a significant sample size
- 09:08based on historical data where the
- 09:10actual study would be taking place.
- 09:12It's also the first of its kind in that it
- 09:15offers objective and subjective outcomes,
- 09:18and we do try to address bias through
- 09:21blinding the participants to the
- 09:25non pharmacological intervention.
- 09:27We do also have limitations.
- 09:29There is difficulty with binding
- 09:30given that a weighted blanket is
- 09:32quite heavy and you can tell it's.
- 09:34Waited up. And there's also a high
- 09:36variability of sleep at baseline.
- 09:39I think I mentioned earlier the average
- 09:41and Niels McHugh is 94 minutes with
- 09:43the variance of 61 minutes pretty high.
- 09:45However, we do try to address that by
- 09:48carrying out the study in yells McHugh.
- 09:50Additionally, there's some limitations
- 09:52with the accuracy of actigraphy,
- 09:54as it is an accelerometer,
- 09:56it's worn on your wrist,
- 09:57and if you're not moving,
- 09:58it's harder for it to track,
- 10:00so it's just one thing to keep
- 10:02in mind when we interpret data.
- 10:04So I just want to thank you all for
- 10:06listening. I want to thank Doctor Nauert.
- 10:08She was an amazing thesis advisor.
- 10:10Thank you.
- 10:11Rosanna and Megan and the Graduate
- 10:13writing lab and everyone who
- 10:14helped get us here to this point
- 10:16and thanks class of 2021.