Nepal Field Study

Infant Incubator Project

Jan 21-27, 2007

Field Team:

Timothy Prestero, DtM

Matt Eckelman, YaleUniv.

Field Study Protocol

Process, Schedule and To-Do Lists

Guiding Principles

Direct all questions toward the idea that the final result will be a low-tech isolette.

Product Brief

Target Functions

Infant Warming: must include monitoring and control

Isolation: not a key product feature in the US, what about Nepal?

Oxygen: dangerous without monitoring, is this in or out?

Additional functions/requirements

Easy access or pass-through

Infant monitoring (instrumentation)
Life-support (assisted respiration, intravenous and oral feeding)
Infant handling (examination, repositioning, changing)

Sterility and cleaning

During use (baby bio messes)
Between infants (clean-out and storage prep)

Monitoring

Infant visibility
Alarms: no signal vs. bad signal

Power supply

Maintenance and repair

Identification and security

Potential “easy wins”

Tilting bed for acid reflux
Integrated scale for infant weight without removal
Ports and gates to prevent baby from rolling off table
Infant skin temp as control input (“servo” mode) via stick-on transducer
Pulse oximeter (low-cost Chinese mfg using 1985-era IP?)
Built in wires for crucial monitoring functions

Research Questions FOLLOW-UP (post-Nepal email, US research, March trip)

Product Priorities

What is the “number one” feature you would want in an isolette (nurse, doctor, parent)? Any "easy wins"?

How common are problems related to excess O2?
What do you think about an integrated pulse oxymeter?

Kanti NICU (close to US resources) vs rural clinic (no resources)

Where is our target market on this continuum?

What environments will the isolette be designed for? Only city hospital?

Users and Interations

Baby access

ASK: Describe the moment-to-moment care in Nepal

What kinds of procedures will they perform?
What kinds of access do they want/need?
What are their routines: rounds, hand-off, on-call

OBSERVE: Access to baby

What happens in real procedures?
Demonstrate putting the baby in the incubator and hooking them up
How often do they move/remove the baby?
How easy/awkward is it?
How many people does it take?

What roles do the parents play?

Do you ever use Kangaroo care?

How might this affect the incubator design?

Air quality inside the incubator

How often are babies changed in the ICU?

How long will they sit in a dirty diaper (average, worst case)?

Is ammonia build-up a problem? Are there any other problematic gasses or contaminants generated inside the incubator?

For the standard incubator, how many air changes per hour? What is desirable?

Incubator functions and allowances (monitoring and life support)

Incubator vs warming table

Relative advantages and disadvantages

Uses, relationship, existence

Order of use in baby care (warming table for critical, “graduate” to incubator?)

Tell us more about alarms and measurements

From what range do you need to be able to see/hear them?

What control do you need over settings?

How reliable? Any false alarms?

Incubator design

What are we seeing about the design?

Allowances inside the incubator for wires, gadgets

Allowances in the housing for access (ports, respirator inlet, bed lift)

Research Questions CLOSED or VALIDATE

Product Priorities

What babies are you trying to help?

What weight ranges (percentages)?

What are the most common additional health issues:

Jaundice
Acid Reflux
Cholera, Typhoid, other infections
Malnutrition

What percent of infants need help with:

Temperature regulation
Nourishment
Breathing

What is important in Nepal to keep a baby alive?

How do they treat these babies now?

Temperature

Isolation and infection control

Oxygen and respiration

Product Environment

Describe the NICU

What is the total capacity of infants in the environment?

What are staff levels? What are the staff-patient ratios?

How much space do they have for storage?

How long do infants stay in the NICU?

Are certain times of year busier than others?

What is the range of environmental conditions in the hospital/environment?

Temperature

Humidity

Light

Noise

What is the basic structure of the infant-related portion of the hospital? What assumptions can we make about the NICU environment?

Will the incubator environment ever exceed 37 degC?

Are mosquitos a problem in summer?

Do contagious staff/parents stay home?

What kind of power is available in all of these environments?

Is surge protection needed?

Is emergency power needed? How long must it last?

What kinds of germ barriers are employed?

What chemicals/methods would be used to sterilize the isolettes?

Do they use any anti-bacterial hand creams?

Do they wear gloves?

Do they wear gowns?

Is the ambient environment filtered in any way?

Are sick people prevented from entering the immediate environment?

Is the environment near the infant well-lit? Is additional lighting required?

Users and Interations

Who are the stakeholders?

Shadow some relevant people; doctor, nurse, parent, maintenance

Who does the moment-to-moment care in Nepal?

What kinds of procedures will they perform?

What kinds of access do they need?

What roles do the doctors play?

What kinds of procedures will they perform? What kinds of access do they want/need?

Who do they interact with?

What is their routine; rounds, hand-off, on-call

What roles do any other staff members play?

What roles do the parents play?

Do you ever use Kangaroo care? How would this affect the incubator design?

Incubator functions and allowances (monitoring and life support)

If naked babies are so much easier to monitor/observe, why are all of the babies in the Kanti NICU covered with clothes and blankets?

What about the infants and their environment do you monitor either through equipment or human observation?

What are the most important indicators?

The qualities

Weight
Body temperature vs skin temperature (difference?)

Baby crying (change me!): can you hear this?

Blood sugar

Bowel movements and urination

Blood oxygen level

Pulse

Respiratory rate

Blood tests

Urine tests

Humidity

Airborn germ levels

Other?

Specific qualities:

SKIN TEMP vs CORE TEMP: Is there a difference or some conversion protocol for determining infant core temperature from measured skin temperature?

Respiration: how is this measured/monitored?

Blood pressure: how is this measured/monitored?

About the measurement

Methods

Instrumentation (gadgets attached to or around baby)

Observation (visual checks of skin color, respiration)

Handling (feeling stomach, organs; checking pulse)

Frequency

Continuously (pulse, temp)

Periodically (diaper weight, baby weight, bloodwork)?

What are the target ranges?

What qualities can you control directly (temp, oxygen sat) vs indirectly (heart rate, blood pressure)?

Instrumentation

Do they ever use a urethral catheter?

Time lag between control settings and system response?

How long does it take an incubator to warm up? And how fast does this need to be in emergency use?

Fact-checking

Double-check vital signs (measured constantly) and high-priority measurements/observations

Validate common and emergency interventions

What kinds of information do they record about the infant, and where/howdo they store that data?

Do the infants have a "chart"?

Where is it located?

Electronic data. other systems

What kinds of equipment are currently used in Nepal? What kinds of equipment will need access to the incubator interior and what does it look like?

Bubble CPAP

Heart monitor

IV for fluids

Feeding tube

Oxygen with nose tube

High-freq respirator with stiff tubing and humidification

Blood Oxygen monitor

Storage requirements?

Diapers, clothes

Gadgets that “belong” to each baby, like nasal suction, transducers

How does Nepal deal with baby waste products; diapers?

Does this isolette need to serve as a high-access isolette as well for procedures?

What kinds of materials are local?

General Questions

Are there any places to get better care in case the baby needs more intensive care?

What kinds of liability issues exist?

Desired observations/assets

Day-in-the-life of a Nepal NICU

Fly on the wall: Shadow one “round” of one patient care (St. Elizabeth’s suggests it’s a four-hour cycle for infant monitoring, changing, feeding, etc). This includes opportunities to observe doctors, nurses, staff and parents interacting with infants and equipment.

Shadow the Kanti NICU doc on his/her rounds (watch for modes of access, monitoring)

Nepal NICU in their own words

Interviews: detailed Q&A with key staff, videotaped for later reference

Roleplaying with Narration: ask nurse/doctor/staff to pantomime the ways that they do or would interact with an incubator

Guided tour: ask nurse/doctor/staff/parent to show us around the NICU while describing what they do (watch for interview creep, interesting but irrelevant stuff)

Nepal NICU context: photos and diagrams

NICU floorplan and work areas, indicate uses of space

Equipment around each baby

Baby roadmap (from delivery room to NICU to going home, with connecting hallways, door, etc)

Synthesis Frameworks and Categories: THINK LIKE A DESIGNER

Patient qualities chart

Measurement

What is monitored

How is it measured (what it means in terms of access)

Methods

Instrumentation (gadgets attached to or around baby)

Observation (visual checks of skin color, respiration)

Handling (feeling stomach, organs; checking pulse)

Frequency

Continuously (pulse, temp)

Periodically (diaper weight, baby weight, bloodwork)?

How critical is the quality

What does it indicate in terms of overall health

Response

Alarm: bad signal vs no signal

Automatic response

Intervention: “controllability” and response time

Baby Journey:

US: womb to warming table to incubator to home

Nepal?

Incubator Journey: use, clean, store

Incubator dependencies: what does this device rely on in order to be successful

Infrastructure and environment

Gadgets and supporting equipment

Doctor/nurse/staff

Parents

Incubator product spec sheet

Research Protocol

Prepare 1-2 page questionnaires (cheat sheets) for each user/subject/setting

Heading: interview categories as a reminder

Page 1: must have questions

Page 2: nice-to-have questions

In general, these cheat sheets are “cross-sections” of the huge question list above

Establish field team assignment list for each day/activity

Who takes notes

Who takes pictures/video

Interview rules of thumb

Keep quiet during the interviewee’s response

Eliminate interviewer input during interviewee response, especially on recordings

don’t guide the answer through “er” and “um”

think about “clean” recordings for later use (ie just the interviewee talking, no chatter or leading comments from interviewer)

Request simultaneous translation rather than synopsis

Synch wristwatch with camera clock, time-stamp key notes for later review

Finish strong

Pay attention to what interviewee says in the last five minutes, when you shut off the camera and start packing up your stuff.

Parting comments tend to be great summaries.

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