Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03720301 |
| Other study ID # |
C.2018.129d |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 17, 2018 |
| Est. completion date |
June 30, 2020 |
Study information
| Verified date |
October 2018 |
| Source |
Brooke Army Medical Center |
| Contact |
Kevin C Peterson, DO |
| Phone |
2109168335 |
| Email |
kevin.c.peterson3.mil[@]mail.mil |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Post-operative sore throat (POST) ranks as the 8th most undesirable effect in the
post-operative period and is noted by up to 90% of patients receiving an endotracheal tube.
[1-3] This study aims to show that a simple 5 minute preoperative and intraoperative
osteopathic medical manipulation protocol can decrease the severity and or the incidence of
post-operative sore throat thereby decreasing morbidity and increasing patient satisfaction
and return to daily life.
Description:
Subjects are selected in the pre-operative area, based on inclusion criteria the night prior
from the operating room list, and given 5 minutes of OMT within 1 hour of intubation and then
given a less than 5 minute pre-extubation treatment in the operating room no earlier than 1
hour and no later than 15 minutes prior to expected extubation. The patient will be given a
survey to be answered at 1 hour, 6 hours, and 24 hours post operatively. Surveys will be
filled out in the hospital by the investigating team electronically or by the subject online
after they have departed the hospital (See data collection section for more detail on this
procedure). In this manner, the subjects' bias and placebo effect will have limited impact on
the study outcomes. There will be randomization tables for men and for women to ensure equal
representation of women in both arms of the trial since they bear an independent risk factor
by their gender. The intubating anesthesiologist will not know which arm the subject is
placed in and will be not be present when the pre-operative treatment is taking place to
prevent recognition of sham vs. protocol treatment and possible bias. To accomplish this,
treatment will be completed behind a closed curtain. Furthermore, it is unlikely that
providers will be able to tell the difference between the sham and protocol treatments if
they should see treatment being accomplished. In order to ensure patients meet the 1 hour
treatment to intubation criteria patients will be selected from the list of first starts or
if they are not on the first start list, treatment will be performed when that patients OR
room is in turnover as turnover times average 30+ minutes at this hospital. By performing
treatments in this manor there is less risk of OR delays which may prolong treatment to
intubation time.
The conduct of the anesthetic is entirely at the discretion of the anesthesia provider but in
order to avoid confounding variables there are several requests that will be made concerning
the conduct of the anesthetic. If these requests are ignored for the benefit of the patient
the subject will be removed from the study as described in this section.
Medications for the induction of anesthesia will be at the provider's discretion, but should
include a paralytic and avoid ketamine whenever possible. Use of airway adjuncts such as
lidocaine laryngo-tracheal atomizers, lidocaine lollypops, ETT lubrication, etc should be
avoided and will result in subject exclusion from this study if used. The exclusion of airway
adjuncts is for obvious reasons and the paralytic requirement is to control for subject gag
reflex differences that may cause excess trauma to the throat in those with sensitive gag
reflexes. Ketamine should be avoided due to the risk of excessive secretions that may result
in subject coughing or increased instrumentation with a suction device, and to control for
the high analgesia that ketamine might impart to subjects that could skew the data analysis.
Use of ketamine during the case will result in removal of the patient from the study, but the
lack of paralytic use will not exclude the subject from this study. ETT selection, stylet
use, and direct laryngoscopy (DL) blade type/size will be at the provider's discretion. A
maximum of 2 intubation attempts will be allowed for subject inclusion into this study to
prevent confounding variables of subject anatomy and difficult airways from skewing the data.
Only providers with 100 or more intubations should perform intubations on study participants
in order to control for poor technique and deviation from this will result in subject removal
from the study. ETT cuff pressure should be set at <25cm H2O by aneroid manometer per
standard practices. Standard American Society of Anesthesiologists recommended monitors will
be employed and maintenance medications will be at provider's discretion with the exception
of nitrous oxide which should be avoided due to the potential that it could diffuse into the
ETT cuffs causing increased cuff inflation pressure, but will not be a criteria for exclusion
from the study. Orogastric and nasogastric tubes should also be avoided as they are a known
risk factor for POST but due to the prevalence of their use in this study's potential
population their use will not result in study exclusion. Reversal and extubation will be at
the provider's discretion with standard extubation criteria and gentle suctioning of
oropharyngeal secretions as needed for subject safety. Oropharyngeal suctioning should be
avoided if possible due to its link to POST, but its exclusion would pose undue risk of
aspiration. Effort should be made to conduct oropharyngeal suctioning as gently as possible.
Intraoperative and postoperative analgesics and steroids will be at provider's discretion.
All postoperative and intraoperative analgesics will be recorded with time given by the
investigative team from the medical record.
No earlier than 1 hour and no later than 15 minutes prior to expected extubation, an
additional short OMT session will be conducted in the OR with the subject still anesthetized.
The intraoperative session is designed to be less than 5 minutes and will involve minimal to
no movement of the subjects head or body so as to not to disturb the surgical team and to
prevent the dislodgement of the ETT. Intraoperative treatment is directed at myofascial
structures to increase lymphatic and vascular flow to wash away inflammatory products and
therefore does not require the subject to be moved or to participate in the treatment.
Intra-operative treatment is preferred over post-operative treatment so that inflammatory
products can be removed prior to the initial post-operative assessment. Additionally,
post-operative treatment sessions could be significantly compromised by patient
post-anesthetic agitation/delirium and would require an additional sham treatment to prevent
patient un-blinding. There will be no intra-operative treatment for the sham arm of the study
to save time and decrease the chance for operative interference. All patients will be told in
the recruitment phase that they may receive a second treatment inter-operatively as part of
the consent for participation process. Intubation surveys will be conducted prior to the
intra-operative treatment session to prevent anesthesia provider bias when they recognize the
patient is or is not receiving the second OMT session. At this point there is no further risk
of bias to the study by un-blinding the provider.
OMT protocol:
OMT employs many techniques that are either considered direct or indirect techniques. Direct
techniques are ones in which the patient is taken into the direction of their motion
restriction and then moved further into that motion restriction to move the movement
"barrier" toward the normal range of motion end point. Static stretching exercises would be
an example of a direct technique. Indirect techniques move the patient away from their motion
restriction, or into their "ease" of motion, then aberrant motion barriers are removed by
allowing the body to reset myofascial stretch and motion receptors thereby returning them to
a balanced range of motion position. An example of an indirect technique would be
counterstrain, where in, a muscle that is hypertonic is passively shortened and held until
the muscle "relaxes" thereby restoring normal tone. After normal tone is restored the muscle
is slowly and passively moved to an anatomically neutral position. Another group of
techniques are called myofascial. These are techniques that can be direct or indirect and are
focused at the facial layer tissues that surround the lymphatic and vasculature systems with
the aim of removing restriction around those vessels so that fluid can flow more freely
through them. The protocol used in this study incorporates direct muscle stretching and
myofascial techniques that are among some of the most basic and easy to perform.
Protocol treatment:
All techniques with patient supine and physician at head of the bed:
1. Soft tissue massage to the posterior cervical musculature for approximately 1 minute
- Start with fingers at the cervical thoracic junction and move in rhythmic anterior
posterior pattern while pulling cephalad with the fingers in an effort to stretch
and relax the paracervical musculature.
2. Muscle energy to the muscles of neck extension approximately 1 minute
- Passively flex the patient's lower cervical vertebra into the barrier of flexion.
With one hand supporting the patients head and one hand palpating the paracervical
musculature of the lower cervical spine, have the patient gently extend their neck
towards the bed while the physician prevents motion for 3-5 seconds. Then have the
patient relax and gently increase the patient's lower cervical flexion once
musculature has relaxed completely. Complete 3 rounds of this.
3. Muscle energy to the Occipital Atlanto (OA) joint 1 minute
- Passively extend the patient's OA joint. With one hand cradling the patients head
at the OA joint and the other hand placing two fingers on the patient's forehead.
Have the patient flex their head by bringing chin to chest gently with only enough
force to flex the muscles of the OA joint. Hold this contraction for 3-5 seconds
then gently move the OA further in the extension once the patient relaxes. Complete
3 rounds of this.
4. Muscle energy to the jaw. Approximately 1 minute
- With patients head resting on a pillow in a sniffing position (lower cervical
flexion and OA extension), passively open the patients jaw to the barrier, with one
had palpating the muscles of mastication and one to two fingers on the patients
chin. Then have the patient gently try to close their mouth against the physician's
resistance. Hold for 3-5 seconds than relax. During the relaxation gently move the
patients jaw further open. Complete 3 rounds.
5. Occipital decompression approximately 1 minute
- with patients occiput resting in the palms of the physicians hands gently press the
pads of the 2nd through 3rd fingers along the base of the occiput and into the OA
joint over the occipital condyles. As the physicians fingers follow along the
occiput toward the condyles a gentle outward (lateral) force is applied by bringing
the physicians elbow together while continuing to palpate for muscle relaxation.
When fingers no longer feel to be "sinking into the neck" (i.e. creep) the
treatment is complete.
6. With time remaining complete another round of soft tissue massage.
Intraoperative techniques:
1. Myofascial "Steering wheel" Technique
- With the physician at the head of the bed the physician places one hand on both of
the patient's shoulders over the trapezius muscles with thumbs behind neck and
fingers over the clavicles. The physician then palpates down to the facial layer
and assess facial motion restrictions in all three planes (anterior/posterior,
lateral, rotational). The physician stacks the restrictions either directly or
indirectly in all three planes and holds the tissue in this way until there is no
more fascial movement or "creep."
2. Sibson's Fascia Release
- The Physician places the pads of 2nd and 3rd digits over the clavicular notch and
applies gentle posterior force to the deep facial layer than applies caudal force
directed posterior to the clavicles. As depth increases and creep slows apply a
gentle lateral force with each hand and hold until creep is no longer perceived.
3. Occipital decompression
- Occipital decompression will be performed as described earlier in the preoperative
treatment under occipital decompression heading.
Sham protocol:
Patients randomized into the sham arm of the study will undergo a controlled trial tested
sham treatment that was shown to induce no statistical improvement in cervical pain or
mobility with zero adverse effects with the subjects unable to tell the difference between
sham and actual protocol treatment. [16] Below is the same sham treatment protocol used in
that study.
1. Movement to the Sham Treatment Position. To move the subject from the neutral position
to the sham treatment position, gentle motion is induced by applying pressure to the
lateral deltoid region of the subject through the palm of 1 hand while stabilizing the
cervical spine with the other hand. This is aimed to induce thoracolumbar side bending
with cervical stabilization. To ensure a lack of motion at the cervical spine during the
procedure, the cervical-stabilizing hand of the investigator will remain underneath the
neck of the subject at all times, isolating the cervical spine from unintended motion
during side bending of the thoracolumbar spine by the hand pressing on the lateral
deltoid. The hand of the investigator, located beneath the cervical spine while inducing
motion, cradles the posterior aspect of the neck, and care will be taken so that the
head will not rotate, side bend, or flex.[16]
2. Holding the Subject in the Sham Treatment Position. When the subject is sufficiently
side bent such that the opposing shoulder nears the edge of the bed, the hand previously
applying force at the lateral deltoid region will be removed, and motion stopped. The
hand previously applying force to the lateral deltoid region is then placed at the
posterior neck (adjacent to the hand still cupping the posterior neck) to assist in
stabilization of the cervical spine, and the subject will rest in this position for 90
seconds.[16]
3. Return to Neutral. The subject will then be returned to midline, again by using gentle
lateral shoulder pressure with manual stabilization of the cervical spine; however, in
this case, the pressure is applied to the opposite shoulder so that the subject can be
returned to the original position. The opposite hand remained beneath the neck of the
subject for stabilization, as was done in step 1. [16]
