[Federal Register Volume 85, Number 42 (Tuesday, March 3, 2020)]
[Notices]
[Pages 12559-12561]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04253]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Prehospital Airway 
Management

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for Supplemental Evidence and Data Submissions.

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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from the public. Scientific 
information is being solicited to inform our review on Prehospital 
Airway Management, which is currently being conducted by the AHRQ's 
Evidence-based Practice Centers (EPC) Program. Access to published and 
unpublished pertinent scientific information will improve the quality 
of this review.

DATES: Submission Deadline on or before 30 days after the date of 
publication of this notice.

ADDRESSES: 
    Email submissions: [email protected].
    Print submissions:
    Mailing Address: Center for Evidence and Practice Improvement, 
Agency for Healthcare Research and Quality, ATTN: EPC SEADs 
Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857.
    Shipping Address (FedEx, UPS, etc.): Center for Evidence and 
Practice Improvement, Agency for Healthcare Research and Quality, ATTN: 
EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, 
MD 20857.

FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301-427-1496 
or Email: [email protected].

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Evidence-based Practice Centers (EPC) 
Program to complete a review of the evidence for Prehospital Airway 
Management. AHRQ is conducting this systematic review pursuant to 
Section

[[Page 12560]]

902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).
    The EPC Program is dedicated to identifying as many studies as 
possible that are relevant to the questions for each of its reviews. In 
order to do so, we are supplementing the usual manual and electronic 
database searches of the literature by requesting information from the 
public (e.g., details of studies conducted). We are looking for studies 
that report on Prehospital Airway Management, including those that 
describe adverse events. The entire research protocol is available 
online at: https://effectivehealthcare.ahrq.gov/products/prehospital-airway-management/protocol.
    This is to notify the public that the EPC Program would find the 
following information on Prehospital Airway Management helpful:
    [ssquf] A list of completed studies that your organization has 
sponsored for this indication. In the list, please indicate whether 
results are available on ClinicalTrials.gov along with the 
ClinicalTrials.gov trial number.
    [ssquf] For completed studies that do not have results on 
ClinicalTrials.gov, a summary, including the following elements: Study 
number, study period, design, methodology, indication and diagnosis, 
proper use instructions, inclusion and exclusion criteria, primary and 
secondary outcomes, baseline characteristics, number of patients 
screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, 
effectiveness/efficacy, and safety results.
    [ssquf] A list of ongoing studies that your organization has 
sponsored for this indication. In the list, please provide the 
ClinicalTrials.gov trial number or, if the trial is not registered, the 
protocol for the study including a study number, the study period, 
design, methodology, indication and diagnosis, proper use instructions, 
inclusion and exclusion criteria, and primary and secondary outcomes.
    [ssquf] Description of whether the above studies constitute ALL 
Phase II and above clinical trials sponsored by your organization for 
this indication and an index outlining the relevant information in each 
submitted file.
    Your contribution is very beneficial to the Program. Materials 
submitted must be publicly available or able to be made public. 
Materials that are considered confidential; marketing materials; study 
types not included in the review; or information on indications not 
included in the review cannot be used by the EPC Program. This is a 
voluntary request for information, and all costs for complying with 
this request must be borne by the submitter.
    The draft of this review will be posted on AHRQ's EPC Program 
website and available for public comment for a period of 4 weeks. If 
you would like to be notified when the draft is posted, please sign up 
for the email list at: https://www.effectivehealthcare.ahrq.gov/email-updates.
    The systematic review will answer the following questions. This 
information is provided as background. AHRQ is not requesting that the 
public provide answers to these questions.

Key Questions (KQ)

Key Question 1

    a. What are the comparative benefits and harms of bag valve mask 
versus supraglottic airway for patients requiring prehospital 
ventilatory support or airway protection?
    b. Are the comparative benefits and harms modified by:
    i. Techniques or devices used?
    ii. Characteristics of emergency medical services personnel 
(including training, proficiency, experience, etc.)?
    iii. Patient characteristics?

Key Question 2

    a. What are the comparative benefits and harms of bag valve mask 
versus endotracheal intubation for patients requiring prehospital 
ventilatory support or airway protection?
    b. Are the comparative benefits and harms modified by:
    i. Techniques or devices used?
    ii. Characteristics of emergency medical services personnel 
(including training, proficiency, experience, etc.)?
    iii. Patient characteristics?

Key Question 3

    a. What are the comparative benefits and harms of supraglottic 
airway versus endotracheal intubation for patients requiring 
prehospital ventilatory support or airway protection?
    b. Are the comparative benefits and harms modified by:
    i. Techniques or devices used?
    ii. Characteristics of emergency medical services personnel 
(including training, proficiency, experience, etc.)?
    iii. Patient characteristics?

Key Question 4

    What are the comparative benefits and harms of the following 
variations of any one of the three included airway interventions (bag 
valve mask, supraglottic airways, or endotracheal intubation) for 
patients requiring prehospital ventilatory support or airway 
protection:
    i. Techniques or devices used?
    ii. Characteristics of emergency medical services personnel 
(including training, proficiency, experience, etc.)?
    iii. Patient characteristics?

   PICOS (Populations, Interventions, Comparators, Outcomes, Settings,
                         Study Design Settings)
------------------------------------------------------------------------
                                                            Exclusion
             PICOS                Inclusion criteria        criteria
------------------------------------------------------------------------
Populations...................  Patients requiring      
                                 prehospital             Patients
                                 ventilatory support     treated with
                                 or airway protection    naloxone to
                                 who are treated in      reverse opioid-
                                 the prehospital         related
                                 setting by emergency    respiratory
                                 medical services        failure.
                                 personnel (paramedic,  
                                 advanced emergency      Patients cared
                                 medical technician,     for in other
                                 emergency medical       than the
                                 technician, emergency   prehospital
                                 medical responder,      setting.
                                 etc.).
Interventions.................   Bag valve      
                                 mask ventilation.       Nasotracheal
                                 Supraglottic    intubation.
                                 airway insertion,      
                                 including dual-lumen    Percutaneous
                                 airways..               devices.
                                 Endotracheal   
                                 intubation..            Surgical airway
                                [cir] Via direct         procedures.
                                 laryngoscopy with or    CPAP
                                 without RSI or DSI..    and BiPAP.
                                [cir] Via video
                                 laryngoscopy with or
                                 without RSI or DSI..
Comparators...................  KQ1: bag valve mask      No
                                 vs. supraglottic        airway
                                 airway.                 management.
                                KQ2: bag valve mask
                                 vs. endotracheal
                                 intubation..
                                KQ3: supraglottic
                                 airway vs.
                                 endotracheal
                                 intubation..
                                KQ4: different
                                 techniques for any
                                 one of the three
                                 included types of
                                 airways..

[[Page 12561]]

 
Outcomes......................  Patient Health          Long-term
                                 Outcomes (highest       outcomes (more
                                 priority).              than 30 days
                                 Mortality/      post-injury).
                                 survival..
                                [cir] To arrival at
                                 hospital..
                                [cir] To hospital
                                 discharge..
                                [cir] Any period less
                                 than or equal to 30
                                 days post-injury..
                                 Morbidity.
                                   [cir] Glasgow
                                    Outcome Scale,
                                    Glasgow Outcome
                                    Scale Extended,
                                    Modified Rankin
                                    Scale, Cerebral
                                    Performance
                                    Category..
                                   [cir] Pneumothorax.
                                   [cir] Aspiration
                                    pneumonia..
                                 Length of
                                 Stay.
                                   [cir] Hospital
                                    length of stay
                                    (days)..
                                   [cir] ICU length of
                                    stay (days)..
                                   [cir] ICU-free
                                    days..
                                Intermediate Outcomes
                                 (secondary priority).
                                 Overall
                                 success rate.
                                 First pass
                                 success rate.
                                 Number of
                                 prehospital attempts
                                 to secure an airway.
                                 EtCO2 values.
                                 Effective
                                 oxygenation.
                                 Effective
                                 ventilation.
                                 Definitive
                                 Airway Sans Hypoxia/
                                 Hypotension on First
                                 Attempt (DASH-1A).
                                Adverse Events/Harms..
                                 Vomiting.
                                 Gastric
                                 content aspiration.
                                 Hypoxia
                                 (SpO2<90%).
                                
                                 Hyperventilation
                                 (EtCO2<35).
                                
                                 Hypoventilation
                                 (EtCO2>45).
                                 Hypotension.
                                 Oral trauma,
                                 airway trauma.
                                 Barotrauma.
                                 Misplaced
                                 tube.
                                 Need for
                                 additional airway
                                 interventions.
Setting.......................   Prehospital..  Airway studies
                                 ED only if      conducted in
                                 needed to fill          cadaver labs,
                                 important gaps where    or simulated
                                 there are no            environments;
                                 prehospital studies..   operating
                                 International   rooms; or
                                 studies in English      inpatient. ED
                                 language..              studies if
                                                         prehospital
                                                         studies of the
                                                         topic are
                                                         available.
Study Design..................   RCTs.........  
                                If RCTs do not provide   Systematic
                                 sufficient evidence,    reviews (we
                                 the following designs   will use
                                 will be included:.      reference lists
                                 Prospective     to identify
                                 comparative studies..   studies for
                                 Retrospective   possible
                                 comparative studies..   inclusion).
                                 Case control    Case
                                 studies..               series.
                                                        
                                                         Descriptive
                                                         studies.
                                                         Letters
                                                         to the editor.
                                                         Opinion
                                                         papers.
                                                         Studies
                                                         published prior
                                                         to 1990.
------------------------------------------------------------------------
BiPAP = bilevel positive airway pressure; CPAP = continuous positive
  airway pressure; DSI = delayed sequence intubation; ED = emergency
  department; ICU = intensive care unit; KQ = Key Question; RCT =
  randomized controlled trial; RSI = rapid sequence intubation


    Dated: 26 February 2020.
Virginia L. Mackay-Smith,
Associate Director, Office of the Director, AHRQ.
[FR Doc. 2020-04253 Filed 3-2-20; 8:45 am]
 BILLING CODE 4160-90-P