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Clinical Safety & Effectiveness Cohort # 16 Implementation of T-Piece Resuscitator (Neopuff) in University Hospital NICU DATE

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Page 1: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

Clinical Safety & Effectiveness Cohort # 16

Implementation of T-Piece Resuscitator (Neopuff) in

University Hospital NICU

DATE

Page 2: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

Background

• ~10% neonates require resuscitative efforts at birth

• Positive Pressure Ventilation (PPV) is key to successful resuscitation

- Positive pressure support should be commenced

at 30-60sec

Page 3: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

Newborn Resuscitation Algorithm

3 John Kattwinkel et al. Pediatrics 2010;126:e1400-e1413

Page 4: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

Choice of Device for PPV

• Depends on availability of gas supply

• Skills of resuscitator

• Desire to deliver pressures:

- Peak inspiratory pressures (PIP)

- Positive end expiratory pressures (PEEP)

Page 5: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

Basics of Positive Pressure Support

Ideally, PPV should be given with PEEP

• More rapid acquisition of functional residual

capacity

• Improved oxygenation and lung compliance

• Decreased lung injury

Page 6: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

Effect of PEEP on Alveolar Volume

Without PEEP With PEEP

www.derangedphysiology.com/php/Respiratory-failure-and-mechanical-ventilation

Page 7: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

Use of Positive Pressure Support

• International guidelines state that PEEP is likely to be

beneficial in stabilization of preterm neonates

–76% of units use PEEP

Page 8: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

Resuscitation Devices

1. Anesthetic Rebreathing Bag

(Current standard of care at UH)

2. Self-Inflating Bag

(Standard of care in some NICUs)

3. T-Piece Resuscitator (Neopuff)

(Proposed standard of care at UH)

Page 9: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

T-Piece Resuscitator (Neopuff)

• Intrinsically provides PEEP

• Delivers more accurate and consistent PIP

• Produces more effective tidal exchange than bag-

and-mask systems

Page 10: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

10

Page 11: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

Does PPV affect subsequent neonatal outcomes?

Page 12: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

PPV “Double Edge Sword”

– Too high of pressure

• Over-distention

• Increase risk of PTX & PIE

• Histological injury to lungs

– Too low of pressure

• Decrease HR

• Chest compressions

• Intubation

Page 13: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

Recommendation by NRP

• According to the American Academy of Pediatrics /

Neonatal Resuscitation Program (NRP) Guidelines

• The T-piece resuscitator should be used during DR

neonatal resuscitation

Page 14: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

Quality Improvement Cycle

www.resultsresults.co.uk

Page 15: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

AIM Statement

To implement the use of Neopuff in the delivery

room for resuscitation of preterm infants in NICU

from 0 % to 50 % by

May 20th, 2015

Page 16: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

16

Project Milestones

• Team Created January 2015

• AIM statement created January 2015

• Weekly Team Meetings Feb 2015

• Background Data, Brainstorm Sessions, Feb 2015

Workflow and Fishbone Analyses

• Interventions Implemented March 2015

• Data Analysis March-May 2015

• CS&E Presentation June 5, 2015

Page 17: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

17

Ishikawa Diagram

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18

PLAN: Intervention

• Met with stakeholders and reviewed the literature

about the use Neopuff; clarified the concerns of the

providers

• 5 Neopuff machines were ordered by the

department of Pediatrics, Neonatology division

• Planned on the use of Neopuff for PPV according to

the neonatal resuscitation guidelines

Page 19: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

PLAN: Intervention

Education of the health care providers:

• Developed the checklist and protocol for the use of Neopuff

• Respiratory therapist did in-service for all the nurses

Organized hand on experience on the use of Neopuff for

residents, NP’s, fellows and attendings

• Had weekly NICU tours and answered the questions about

the use of Neopuff

• Had meeting with OB-team and clarified their concerns

Page 20: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

DO: Implementing the Change

Started the use of Neopuff on March 1st, 2015

Encountered problems:

• Missing patient supplies

• Reminders for HCP’s

• Technical issues

• Follow up on overnight admissions

• Monthly meetings / Journal club discussion

Page 21: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

CHECK: Results/Impact

• Reviewed all the charts of babies less than 32 weeks

gestational age and required PPV in the DR

• Pre intervention group 28 patients

• Post intervention group 11 patients

• Relatively more premature babies in Neopuff group

Page 22: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

CHECK: Results/Impact

• Neonatal outcomes:

Apgar scores at 1 & 5 mins, DR intubations,

RDS, pneumothorax, PIE, mechanical ventilation days in

first week, IVH > grade 2, hydrocephalus

• Developed check list for data extraction

• Data were collected from chart reviews over a three month

period: Dec, Jan and Feb 2015

Page 23: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

UCL 12.01

12.91

CL 5.18

5.73

0

2

4

6

8

10

12

14

12/3

/1

4 5

:0

5 A

M

12/6

/1

4 1

2:0

0 A

M

12/1

2/14

12

:00

A

M

12/1

8/14

11

:06

A

M

12/1

8/14

1:4

7 P

M

12/2

1/14

7:5

8 A

M

12/3

0/14

3:1

6 P

M

12/3

0/14

6:1

5 P

M

1/6/15

9

:36

P

M

1/10

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5 5

:3

7 P

M

1/12

/1

5 9

:1

4 P

M

1/15

/1

5 1

2:5

8 P

M

1/15

/1

5 7

:5

6 P

M

1/15

/1

5 7

:5

6 P

M

1/15

/1

5 7

:5

7 P

M

1/15

/1

5 1

1:2

2 P

M

1/23

/1

5 6

:0

7 A

M

1/24

/1

5 2

:2

2 A

M

1/24

/1

5 2

:2

4 A

M

1/25

/1

5 4

:1

6 A

M

1/28

/1

5 2

:0

8 P

M

1/31

/1

5 1

2:1

1 A

M

2/8/15

1

:32

P

M

2/15

/1

5 7

:2

5 A

M

2/17

/1

5 7

:1

9 A

M

2/22

/1

5 9

:2

2 A

M

2/25

/1

5 2

:4

6 A

M

2/27

/1

5 2

:5

7 A

M

3/7/15

5

:39

P

M

3/9/15

5

:59

P

M

3/10

/1

5 1

1:2

1 P

M

3/14

/1

5 2

:1

2 P

M

3/16

/1

5 8

:3

6 A

M

4/2/15

2

:25

A

M

4/4/15

8

:42

A

M

4/19

/1

5 1

1:3

0 A

M

4/27

/1

5 1

1:1

3 A

M

5/7/15

1

2:0

0 A

M

5/10

/1

5 1

2:0

0 A

M

Ap

ga

r sc

ore

s at 1

m

in

Date of Birth

Apgar scores at 1 min

Pre and Post Neopuff

Page 24: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

UCL 15.05 15.22

CL 7.07 7.18

0

2

4

6

8

10

12

14

16

12/3

/1

4 5

:0

5 A

M

12/6

/1

4 1

2:0

0 A

M

12/1

2/14

12

:00

A

M

12/1

8/14

11

:06

A

M

12/1

8/14

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7 P

M

12/2

1/14

7:5

8 A

M

12/3

0/14

3:1

6 P

M

12/3

0/14

6:1

5 P

M

1/6/15

9

:36

P

M

1/10

/1

5 5

:3

7 P

M

1/12

/1

5 9

:1

4 P

M

1/15

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5 1

2:5

8 P

M

1/15

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5 7

:5

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1/15

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:5

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1/15

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5 7

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1/15

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1/23

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:0

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M

1/31

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M

2/8/15

1

:32

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M

2/15

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5 A

M

2/17

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9 A

M

2/22

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5 9

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2 A

M

2/25

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5 2

:4

6 A

M

2/27

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5 2

:5

7 A

M

3/7/15

5

:39

P

M

3/9/15

5

:59

P

M

3/10

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1:2

1 P

M

3/14

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5 2

:1

2 P

M

3/16

/1

5 8

:3

6 A

M

4/2/15

2

:25

A

M

4/4/15

8

:42

A

M

4/19

/1

5 1

1:3

0 A

M

4/27

/1

5 1

1:1

3 A

M

5/7/15

1

2:0

0 A

M

5/10

/1

5 1

2:0

0 A

M

Ap

ga

r sc

ore

s at 5

m

in

s

Date of Birth

Apgar scores at 5 mins

Pre and Post Neopuff

Page 25: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

UCL 7.66

4.87

CL 2.71

1.36

0

1

2

3

4

5

6

7

8

9

12/3

/1

4 5

:0

5 A

M

12/6

/1

4 1

2:0

0 A

M

12/1

2/14

12

:00

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M

12/1

8/14

11

:06

A

M

12/1

8/14

1:4

7 P

M

12/2

1/14

7:5

8 A

M

12/3

0/14

3:1

6 P

M

12/3

0/14

6:1

5 P

M

1/6/15

9

:36

P

M

1/10

/1

5 5

:3

7 P

M

1/12

/1

5 9

:1

4 P

M

1/15

/1

5 1

2:5

8 P

M

1/15

/1

5 7

:5

6 P

M

1/15

/1

5 7

:5

6 P

M

1/15

/1

5 7

:5

7 P

M

1/15

/1

5 1

1:2

2 P

M

1/23

/1

5 6

:0

7 A

M

1/24

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5 2

:2

2 A

M

1/24

/1

5 2

:2

4 A

M

1/25

/1

5 4

:1

6 A

M

1/28

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5 2

:0

8 P

M

1/31

/1

5 1

2:1

1 A

M

2/8/15

1

:32

P

M

2/15

/1

5 7

:2

5 A

M

2/17

/1

5 7

:1

9 A

M

2/22

/1

5 9

:2

2 A

M

2/25

/1

5 2

:4

6 A

M

2/27

/1

5 2

:5

7 A

M

3/7/15

5

:39

P

M

3/9/15

5

:59

P

M

3/10

/1

5 1

1:2

1 P

M

3/14

/1

5 2

:1

2 P

M

3/16

/1

5 8

:3

6 A

M

4/2/15

2

:25

A

M

4/4/15

8

:42

A

M

4/19

/1

5 1

1:3

0 A

M

4/27

/1

5 1

1:1

3 A

M

5/7/15

1

2:0

0 A

M

5/10

/1

5 1

2:0

0 A

M

Me

ch

an

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first w

ee

k

Date of Birth

Mechanical ventilation days in first week

Pre and Post Neopuff

Page 26: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

0 10 20 30 40 50 60 70 80 90

DR Intubation

Surfactant

RDS

PIE

Pnuemothorax

IVH > Grade 2

Hydrocephalus

Neonatal Outcomes in Pre and Post

Neopuff

Post

Pre

Page 27: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

UCL 6.96

6.61

CL 2.36 2.18

0.0

1.0

2.0

3.0

4.0

5.0

6.0

7.0

8.0

12/3

/1

4 5

:0

5 A

M

12/6

/1

4 1

2:0

0 A

M

12/1

2/14

12

:00

A

M

12/1

8/14

11

:06

A

M

12/1

8/14

1:4

7 P

M

12/2

1/14

7:5

8 A

M

12/3

0/14

3:1

6 P

M

12/3

0/14

6:1

5 P

M

1/6/15

9

:36

P

M

1/10

/1

5 5

:3

7 P

M

1/12

/1

5 9

:1

4 P

M

1/15

/1

5 1

2:5

8 P

M

1/15

/1

5 7

:5

6 P

M

1/15

/1

5 7

:5

6 P

M

1/15

/1

5 7

:5

7 P

M

1/15

/1

5 1

1:2

2 P

M

1/23

/1

5 6

:0

7 A

M

1/24

/1

5 2

:2

2 A

M

1/24

/1

5 2

:2

4 A

M

1/25

/1

5 4

:1

6 A

M

1/28

/1

5 2

:0

8 P

M

1/31

/1

5 1

2:1

1 A

M

2/8/15

1

:32

P

M

2/15

/1

5 7

:2

5 A

M

2/17

/1

5 7

:1

9 A

M

2/22

/1

5 9

:2

2 A

M

2/25

/1

5 2

:4

6 A

M

2/27

/1

5 2

:5

7 A

M

3/7/15

5

:39

P

M

3/9/15

5

:59

P

M

3/10

/1

5 1

1:2

1 P

M

3/14

/1

5 2

:1

2 P

M

3/16

/1

5 8

:3

6 A

M

4/2/15

2

:25

A

M

4/4/15

8

:42

A

M

4/19

/1

5 1

1:3

0 A

M

4/27

/1

5 1

1:1

3 A

M

5/7/15

1

2:0

0 A

M

5/10

/1

5 1

2:0

0 A

M

# o

f 7

P

ossib

le

Date of Birth

Combined Neonatal Outcomes

Pre and Post Neopuff

Page 28: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

ACT: Sustaining the Results

• The use of Neopuff was 100 % in the DR

• DR use of Neopuff guidelines, will be a part of NICU manual

• In-service will be provided to new employees (residents,

NNP’s and fellows during NICU orientation

• Respiratory therapist structured note will be embedded in

the EMR which will help in the data extraction

• Every month the data will be analyzed and discussed in the

NICU QI meeting

Page 29: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

29

Return on Investment (ROI)

• In NICU we do “Bundle Billing” on the basis of the

severity of illness and not on the basis of individual

problems list like Pneumothorax, IVH etc. That is why it

is difficult to determine ROI

• It will be interesting to look at the Length of stay (LOS)

and will determine the ROI; but most of the babies in

post-intervention group are still in-house

Page 30: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

Return on Investment (ROI)

• What will be the LOS in babies with hydrocephalus

and further neurodevelopmental outcomes ?

• Days on mechanical ventilation is associated with

Bronchopulmonary Dysplasia (BPD); need to know

how many babies develop BPD at the time of

discharge ?

30

Page 31: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

31

Conclusion/What’s Next

We observed that in the post-intervention group

• The Apgar scores were improved or not worsened

• Babies stayed on the mechanical ventilator for less number of days

• Less number of babies developed PIE, Pneumothorax, IVH grade 2 and Hydrocephalus

• RDS and intubation rate were higher in those babies; that may be due to being more immature ?

Page 32: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

The Team

–Syed Shah, MD

– Irene Sandate, NP

–Rachel Rivas, RN

–Rachael Farner, RN

–Eric Larson, RT

–Karen Aufdemorte, Facilitator

–Amy Quinn, MD

–Margarita Vasquez, MD

–Donald C McCurnin, MD

–Steven R Seidner, MD

Sponsor Department: Department of Pediatrics, Neonatology Division

Page 33: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

33

Page 34: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

34

Thank you!

Questions ? Comments….

Page 35: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

Anesthetic Rebreathing Bag

• Delivered pressure and tidal volume depend on how hard bag is squeezed

–Pressure-limiting valve

–Manometer

• PEEP delivered by controlling rate of gas escaping from back of bag during expiration

Page 36: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

Self-Inflating Bag (SIB)

• Depends on flow of air or O2

• Peak pressure dependent on operator

–Valve limits maximum pressure delivered

Page 37: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

T-Piece Resuscitator (TPR) (Neopuff)

• Requires continuous gas supply to

generate set peak pressure and set PEEP

• Two ports attach to TPR

–One port goes to oxygen (green tubing)

–One port goes to patient (white tubing)

Page 38: Clinical Safety & Effectiveness Cohort # 16 Implementation ...uthscsa.edu/cpshp/CSEProject/Cohort16/Team1_Shah.pdf · Clinical Safety & Effectiveness Cohort # 16 Implementation of

Literature Evidence

• Compared PPV during DR resuscitation in neonates with

Neopuff (40 pts) and self-inflating bag (50 pts)

• The duration of PPV in delivery room was significantly less in

Neopuff group (p < 0.001)

• A fewer neonates required DR intubation in Neopuff group

(p = 0.04)

• In the Neopuff group, a higher proportion of neonates

resuscitated with room air only (p = 0.001)

Anup Thakur et al, T-piece or self inflating bag for positive pressure ventilation during delivery room

resuscitation: An RCT. Resuscitation 90 (2015) 21–24

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Literature Evidence

• Studied 31 operators using a Neopuff, a self-inflating bag

and a flow-inflating bag during 30 s of ventilation on a

neonatal manikin

• Compared the delivery of consistent PIP of 20 or 40 cm of

cm H2 O and a PEEP of 5 cmH2 O

• The Neopuff delivered the desired pressures more

accurately than the two other devices

Stacie Bennett et al. A comparison of three neonatal resuscitation devices. Resuscitation 67 ; 2005