Anesthesia, General Clinical Trial
Official title:
A Clinical Study of the USASK Airway - An Improved Oral Airway for Bag-Mask Ventilation
NCT number | NCT04238507 |
Other study ID # | BIO-1324 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 22, 2019 |
Est. completion date | September 2020 |
A clinical study of USASK AIRWAY - An Improved Oral Airway for Bag-mask Ventilation
A clinical study of MA AIRWAY - An Improved Oral Airway for Bag-mask Ventilation We report a
study with University Research Ethics Board approval of a new oral airway device, the McKay
Airway (MA), designed for easy maintenance of jaw-thrust (see illustration) for first
responders who may perform bag-mask venti-lation (BMV) infrequently, and who often do not
perform it well. Null hypothesis: naïve learners' time to achieve exhaled tidal volume (VE)
>300ml will be no dif-ferent using MA than using a Guedel oropharyngeal airway (OPA) on
anesthetized patients. Design was a repeated-measures unblinded controlled trial with blinded
randomization of the order of airway use, comparing MA versus OPA conducted from July until
December 2019. Anesthesiologists' decision to intervene and comments were recorded.
Consenting learners included medical students, resi-dents from specialties other than
anesthesiology, operating room staff, or naïve learners in technical courses scheduled in the
operating rooms to be taught airway management. Patients were consenting adults booked for
elective surgery under general anesthesia (GA). Excepted patients were those with loose
incisors, tem-poromandibular joint disorders, reflux, those who did not wish to participate,
and those whom the attending anesthesiologist felt put them at any added risk by
par-ticipating. For patients with missing teeth, we padded the MA surface with 1cm thick
stick-on sponge (Reston™ Self-Adhering Foam Pads; 3M, Maplewood MN USA). Patients were under
the direct care of the consenting staff anesthesiologist for that OR. They were recruited in
Pre-Admission Clinic, the hospital wards, Same-Day and Day-Surgery units, and in the OR
holding area.
The experimental procedure included normal preoxygenation, induction of anesthesia, and BMV
by the attending anesthesiologist as needed to assure high oxygen saturation prior to opening
an opaque numbered envelope to randomly choose which airway to use first. We mimicked a
self-inflating BMV device with the anesthetic machine by setting the Adjustable Pressure
Limiting (APL) valve to >30cm water pressure and using the oxygen flush to ensure that the
reservoir bag was filled between breath attempts. With the randomized airway in place,
learners applied the mask with their left hand, squeezing the bag with their right
approxi-mately every 3s. We timed from the first bag squeeze until VE exceeded 300ml, then
repeated the experiment with the other airway. We approached 56 patients, recruited 34 female
and 20 male, and obtained data for 51. One obese patient had severe succinylcholine
fasciculations with rapid profound desaturation and the an-esthesiologist took over
immediately, and for two the anesthesiologist misunder-stood the experiment. Time
measurements were analysed with Wilcoxon's Signed Rank test, incidences with Fisher's Exact
test or Chi Square. MA allowed faster adequate ventilation than OPA: Hodges-Lehmann median
difference: 6s [95% CI 5 to 6.3s]; quartiles: OPA 9.5 to 37s; MA 7 to 16s range: OPA 5 to
78s; MA 2 to 49s; p = 0.02. When used first, the MA was faster than the OPA 30% of times
compared to 11% when OPA was used first (p = 0.04), suggesting that MA may be easier to
learn. Comments: 16 preferred the MA, 2 the OPA, and 15 had no preference (p = 0.02 compared
to equal preferences). Further studies are warrant-ed.
Status | Recruiting |
Enrollment | 65 |
Est. completion date | September 2020 |
Est. primary completion date | July 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility |
Inclusion Criteria: Participants are of three kinds: learners, patients, and
anesthesiologists. Learners will be consenting medical students, residents from specialties
other than anesthesiology, or naïve learners in the Respiratory Technician or Emergency
Medical Technician courses, all of whom are routinely rotated through the Saskatoon
operating rooms (ORs) to learn airway management. Excepted will be learners who do not wish
to participate. Patients will be consenting adult (age = 18 years) patients booked into the
operating rooms of SHR for elective surgery under general anesthesia (GA). BMV is normal
clinical practice for all patients as part of the induction and emergence phases of GA - Exclusion Criteria: Excepted patients will be those with temporomandibular joint disorders, those who do not wish to participate, those whom the attending anesthesiologist feels puts them at any added risk by participating, and those whose anesthetic plan is changed from GA to a regional anesthetic technique - |
Country | Name | City | State |
---|---|---|---|
Canada | Saskatoon Health Region, 410 22nd Street East | Saskatoon | Saskatchewan |
Lead Sponsor | Collaborator |
---|---|
University of Saskatchewan |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time from applying the mask to achieving ventilation | Time from applying the mask to achieving ventilation with tidal volume >300ml. | 1 minute | |
Secondary | airway use questions | An anesthesiologist's decision to intervene and take over BMV will be noted and counted should it occur. If there is adequate ventilation by 30s, the attempt will be considered a success; otherwise a failure. Scores will be recorded on rating scales for each BMV method: ease of insertion, ease of holding the mask properly, ease of obtaining a good seal, ease of obtaining an open airway, and likelihood of employing the method in practice. Comments about overall impression will be recorded. | 15 minutes |
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