LifeStat, The Emergency Pocket Airway Tool THE EMERGENCY AIRWAY DEVICE

 Utilization of the Lifestat Emergency Airway Device
Debbie A Mouadeb, MD Caterine J. Rees, MD, and Peter C. Belafsky, MD, PhD
Presented at the American Broncho-Esophagological Association meeting at the Combined Otolaryngological spring meeting, San Diego, California, April 26-27, 2007

Abstract

Background: Management of the emergency airway may be a harrowing experience. The equipment necessary to perform this procedure is often inaccessible. The Lifestat emergency airway is a portable device approved by the Food and Drug Administration in 1997 for emergency cricothyrotomy. It is small enough to secure to a keychain, thus allowing instantaneous access at all times.

Objective: To report the experience of clinicians who have utilized the Lifestat deive.

Study Design: Retrospective case series.

Methods: A survey instrument was sent to a convenience sample of health care professionals that purchased the Lifestat emergency airway. The survey queried device utilization, user demographics, success, ease, complications, and location of use.

Results: One thousand surveys were distributed and 100 individuals responded. Fifteen percent (15/100) reported use of the device on 17 occasions. The Lifestat was used successfully in 100% of  cases (17/17). Eighty-two percent (14/17) of emergency use was in the hospital. In all cases the device was positioned successfully on the first attempt. No complications were reported.

Conclusions: The Lifestat device provides a safe and effective means of performing emergency cricothyrotomy. The majority of emergency airways where the device was deployed occurred in the hospital setting.

Keywords: Airway obstruction, airway management, cricothyrotomy

Introduction

Airway obstruction leads to death in minutes if untreated. When endotracheal intubation is difficult or impossible to perform in a timely manner, emergency cricothyrotomy is an important method of establishing a definitive surgical airway. Indications for emergency cricothyrotomy include maxillofacial trauma, laryngeal trauma, and upper airway obstruction from swelling, tumors, or a foreign body.  Airway control on the battlefield is often necessary in the patient with respiratory failure secondary to inhalation burn, chemical, or blast injury, and in the patient with direct airway trauma. Patients requiring emergency airway management before reaching a field hospital may constitute up to 5 to 10% of the total combat casualty population. Cricothyrotomy is often necessary, when intubation fails, but it can be difficult to perform and most corpsmen and medics have little experience with this procedure.

The proficiency with which health care workers execute a cricothyrotomy is difficult to investigate as this procedure is often performed in an unexpected setting and used almost exclusively in uncontrolled situations. The complication rate has been reported as high as 40% in emergent circumstances. Complications include tissue laceration or fracture, bleeding, improper tube placement, and damage to local structures including nerves and vessels.

Improvements in airway devices must provide emergency service personnel with an advantage to meet the challenges of the field setting, and to enhance survivability10.. In response to this need, an Otolaryngologist designed the LifeStat emergency airway device (Lifestat Inc, Louisiana, USA). The device was approved for emergency use by the United States Food and Drug administration in 1997 and to date more than three thousand devices have been sold. It is only available for purchase by health care professionals. The purpose of this study was to evaluate the utilization and safety of the Lifestat emergency airway.

Materials and Methods

The Lifestat device is small and lightweight enough to fit on a keychain, in a pocket, or in an emergency kit. The simple configuration allows relative ease of insertion and operation, even when conditions are not optimal. Once inserted, spontaneous or assisted breathing is possible. The tube is adaptable to hand held or automatic respirator. In addition, the LifeStat may remain in position during subsequent attempts at oral intubation.

A survey instrument was sent by the distributor to a convenience sample of health care professionals that purchased the Lifestat emergency airway device. One thousand direct mail surveys were sent. The survey queried utilization, user demographics, success, ease, and location of use. All data was coded and recorded into a de-identified database in SPSS 11.0 for the Macintosh (SPSS Inc, Chicago, IL). This study was deemed exempt from the Institutional Review Board at the University of California, Davis.

Results

One thousand direct mail surveys were sent. One hundred clinicians responded to the survey (10%). Fifteen of the one hundred clinicians (15%) reported using the device on 17 occasions. Health care professionals who used the device included six Otolaryngologists, three Anesthesiologists, one Nurse Anesthetist, four General Surgeons, and one Emergency Room physician. Fourteen of the 17 Lifestat employments (82%) occurred in the hospital setting. Three (17%) occurred at a social gathering. The mean SD age of the patients was 48 20 years, with a 3:1 male to female ratio. Of the hospital events, occurred in the Operating room, 3 on the ward, 2 in the recovery room, 2 in the intensive care unit secondary to difficult anatomy, and a patient with oropharyngeal bleeding obscuring the view of the and 3 in the emergency room. The experiences in the operating room were all cases where the patient  was a difficult laryngoscopy or intubation, and the patient went into rapid respiratory arrest. Lessinvasive methods to rescue a difficult airway (flexible fiberoptic intubation, laryngeal mass airway,esophagotracheal airway) were attempted as appropriate but failed. The diagnosis included a case oflaryngospasm, a patient with an obstructing hypopharyngeal mass, a patient that was not intubatableairway. The two cases that occurred in the recovery room were secondary to respiratory arrest. Of theevents occurring in the ICU, one was a patient who developed a tension pneumothorax and the Lifestatdevice was placed in the second intercostal space at the midclavicular line to relieve the pressure. Theother was a patient who went into respiratory arrest and was not intubatable. The three patients thatrequired an urgent cricothyrotomy on the ward had airway obstruction, one from food and two from asupraglottic masss. In the Emergency Room the device was used on two patients with massive facialtrauma and one patient with a fish bone lodged in the larynx. There were three reports of the device being used outside of the hospital. It was used by an Otolaryngologist when a 16 year old boy went into anaphylactic shock from a peanut allergy; a General Surgeon who was diving when a friend went into cardiac arrest; and an Otolaryngologist in religious services when a 78 year old female went into cardiac arrest. The operators considered the device successful at establishing a temporary airway in all 17 cases. In all cases the device was positioned successfully on the first attempt. There were no complications reported.

Discussion

Emergency airway teams should be facile with several rescue airway devices, because each has an intrinsic failure rate reflecting the experience and judgment of the clinician and the patient's clinical condition and airway characteristics. Emergency cricothyrotomy is indicated only when alternative means of airway control fail, are not available, or are contraindicated. In the hospital setting, an attempt to secure a difficult airway should include oral or nasal intubation, as well as a non-invasive rescue technique such as fiberoptic intubation, laryngeal mask airway, or an esophago-tracheal tube, prior to proceeding to a surgical airway. While elective cricothyrotomy has both a high success rate and a low risk of complications, in emergency settings when the procedure may be a “life-or-death” attempt to obtain airway control, success is less likely and the complication rate necessarily higher. Our data suggest that the Lifestat emergency airway can be used successfully in an emergency situation when other less invasive methods of securing an airway are not available or not possible. In addition, there were no reported associated complications with the placement of the device.

Some of the strengths of the device are that it is portable (fits on a keychain), lightweight, and durable. It can be autoclaved and re-sterilized after employment. A significant number of these devices have been sold to armed forces servicemen. It would be interesting to evaluate the experiences of servicemen who have used the device in the field. They were not included in the convenience sample of this investigation.

While the device was initially developed for use in the community or battlefield outside of the hospital setting, it was interesting that the majority of reported employments occurred in the hospital where access to instruments needed for a standard cricothyrotomy are generally available (82%). This finding suggests the possibility of a user preference with the device and has led us to consider several possiblereasons: 1) Clinicians may find the Lifestat device simpler to use then than other available hospitalequipment. 2) Clinicians may perceive the Lifestat device as safer than other available hospitalequipment. Unlike a standard open cricothyrotomy, the Lifestat emergency airway device relies on atechnique that is analogous to other procedures performed by healthcare professionals on a moreroutine basis. The seldinger technique is used routinely in the field, in the emergency room and in theintensive care unit to place vascular lines. It is also used for placement of percutaneous tracheotomiesand to perform tracheotomy tube changes on the ward. As such, this approach may offer an advantageover standard surgical cricothyrotomy because of familiarity with the technique. 3) While it is not known whether health care professionals who used the device had it on their keychain or in their pocket, it is possible that instantaneous access to the device offered an advantage over the availability of other hospital equipment in an emergency situation. There are several limitations of this study. Lower response rates are typical of physician surveys. The low response rate in this investigation limits the strength of any conclusions that can be drawn. Surveys with response rates of 10% have, however, been published in major medical journals. The success rate of the Lifestat device was reported to be 100% with a 0% complication rate. It is possible that there was a selection bias in thatclinicians who utilized the Lifestat device unsuccessfully were less likely to respond to the survey. It isalso possible that the respondents in this investigation were not representative of the entire group ofpeople who purchased the Lifestat emergency airway device. The narrow scope of our respondents (14physicians, 1 nurse anesthetist) prevents us from making any conclusions about the utility of this devicein the field when used by paramedics. In order to elucidate differences with insertion time, ease of use,and complications between the Lifestat emergency airway device and the standard cricothyrotomytechnique, further prospective investigation is necessary.

Conclusions:

The survey data suggest that the Lifestat emergency airway device is a safe and effective tool for emergency cricothyrotomy. The majority of employments of the device were in the hospital setting, indicating a possible clinician preference for the Lifestat emergency airway device over other standard hospital equipment.

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FDA Notice:

THE FDA AUTHORIZES THIS DEVICE FOR USE BY MEDICAL PERSONNEL, ONLY FOR THE PURPOSE OF ESTABLISHING AN EMERGENCY AIRWAY, AND IS NOT TO BE REUSED.