|
Indian Pediatr 2018;55:793-796 |
|
Target Oxygen
Saturation Among Preterm Neonates on Supplemental Oxygen
Therapy:
A Quality Improvement Study
|
Sindhu Sivanandan 1,
Tavpritesh Sethi2,
Rakesh Lodha2,
Anu Thukral1, M
Jeeva Sankar1,
Ramesh Agarwal1,
Vinod K Paul1 and
Ashok K Deorari1
From 1Division of Neonatology and 2Department
of Pediatrics, All India Institute of Medical Sciences, New Delhi,
India.
Correspondence to: Dr Ashok K Deorari, Professor and
Head, Department of Pediatrics, WHO Collaborating Centre for Education&
Research in Newborn Care, All India Institute of Medical Sciences,
Ansari Nagar, New Delhi 110 029, India.
Received: February 07, 2018;
Initial review: April 02, 2018;
Accepted: August 09, 2018.
|
Objective: To avoid excessive oxygen exposure and
achieve target oxygen saturation (SpO2) within intended range of 88%-95%
among preterm neonates on oxygen therapy. Methods: 20 preterm
neonates receiving supplemental oxygen in the first week of life were
enrolled. The percentage of time per epoch (a consecutive time interval
of 10 hours/day) spent by them within the target SpO2 range was measured
in phase 1 followed by implementation of a unit policy on oxygen
administration and targeting in phase 2. In phase 3, oxygen saturation
histograms constructed from pulse-oximeter data were used as daily
feedback to nurses and compliance with oxygen-targeting was measured
again. Results: 48 epochs in phase 1 and 69 in phase 3 were
analyzed. The mean (SD) percent time spent within target SpO2 range
increased from 65.9% (21.4) to 76.5% (12.6) (P=0.001).
Conclusion: Effective implementation of oxygen targeting
policy and feedback using oxygen saturation histograms may improve
compliance with oxygen targeting.
Keywords: Monitoring, Oxygen management, Pulse oximetry.
|
E xcessive oxygen use or hyperoxia among preterm
neonates is associated with morbidities like retinopathy of prematurity
(ROP) and chronic lung disease (CLD) [1]. Delivering optimal oxygen
involves maintaining the oxygen saturation (SpO2)
within a narrow range by adjusting the inspired oxygen concentration. In
our neonatal intensive care unit (NICU), we observed that nurses faced
difficulty in maintaining SpO2
of neonates within the unit’s target range, often
resulting in fluctuating SpO2
values. We planned this quality improvement (QI) study to
evaluate the existing compliance with oxygen saturation targeting in our
NICU, and whether implementation of a unit policy on oxygen
administration would improve the compliance.
Methods
This was a prospective before-and-after QI study
conducted in a 10-bedded level III NICU of a tertiary care teaching
hospital in India from January to May 2016 in three phases; phase-1 (6
weeks), phase-2 (4 weeks) and phase-3 (6 weeks).
We enrolled preterm neonates (26 to 34 weeks
gestation) who were receiving oxygen while intubated or non-invasively
by any mode for a consecutive 10 h interval (coinciding with pulse-oximetry
data retrieval called an epoch) during the first week of life. Neonates
with major malformations were excluded. Each enrolled neonate could
contribute SpO 2 data for a
maximum of 14 epochs (2 per day for 7 days). The oximetry data was not
collected if the neonate was on high frequency ventilation or had
persistent pulmonary hypertension of newborn (PPHN) or shock.
In phase-1, enrolled neonates were managed as per
existing unit protocol. Intermittent survey of pulse-oximeter alarm
settings was done and pulse-oximeter data was collected for measuring
baseline SpO 2 targeting.
Pulse-oximeters used were Mindray System Beneview T5 (Shenzhen Mindray
Bio-Medical Electronics, China) with SpO2
pick up range of 0-100% (resolution 1%, accuracy 3% between SpO2
70-100% and averaging time 7-11 seconds). The SpO2
data recorded at 1-minute interval for 10-hour epoch was analyzed using
R programming language.
The mean (SD) percentage of time within the target
SpO 2 range during phase-1
was calculated to be 65.9 (21.4) %. Our aim was to improve baseline
compliance of 65% by 20% over the next 10 weeks by implementing a unit
policy on oxygen administration.
A QI team was formed consisting of a neonatologist, a
nurse educator, resident doctor and charge nurse of the unit. The team
reviewed the literature and developed a comprehensive policy addressing
saturation targets, alarm settings, an algorithm for responding to low
and high SpO 2 alarms and
issues like pre-oxygenation. The unit’s goal of targeting SpO2
between 90 to 93% with the low and high alarm limits set at 88 and 95%,
respectively remained the same.
In phase-2, the nurse educator and resident doctor
conducted educational sessions for nurses on the unit’s oxygen policy
over a period of 4 weeks. A pre-post test assessment was done to ensure
knowledge transfer. Visual reminders in the form of postcards depicting
SpO 2 targets, alarm limits
and the algorithm were displayed in the unit. QI team provided feedback
to nurses when incongruent alarm settings were noted during surveys. In
phase-3, compliance with unit’s oxygen policy was reinforced and
saturation histograms made from the retrieved pulse-oximeter data were
presented to nurses during morning rounds. The histograms provided
immediate visual feedback of neonate’s SpO2
trend in the previous 10 hours.
The primary outcome measure for the study was the
percentage of time per epoch spent within the target SpO 2
range of 88-95%. Other outcomes were the percent time per epoch spent in
hyperoxia (SpO2 >95%) or
hypoxia (SpO2 < 88%), and
clinical outcomes such as in-hospital mortality, duration of
supplemental oxygen therapy (in days), incidence of Bronchopulmonary
dysplasia (oxygen requirement on day 28 of life) and ROP requiring
therapy. As process measures, we noted the pre-post test scores of
nurse’s assessment after educational intervention and compliance with
alarm settings in pulse-oximeter.
We estimated that a sample size of 27 patient-epochs
per phase was required to provide a power of 80% using a significance
level of 0.05 to detect a difference of 20% in primary outcome.
Statistical analyses: We considered whether
percentage of time spent in various target SpO 2
ranges were associated with individual characteristics of the neonate
using generalized estimating equation (GEE) and also adjusted for NICU
characteristics (nurse strength per shift, bed occupancy per shift and
the number of neonates on invasive and non-invasive ventilation modes).
Results
A total of 20 neonates; 9 in phase-1 and 11 in
phase-3 contributed to 48 and 69 epochs of saturation data respectively
(Web Fig. 1). Their demographics were
comparable but NICU had significantly higher census, and more neonates
on respiratory support in phase-1 (Table I). The
compliance with correct alarm settings was 39% in phase-1 and 100% in
phase-3. Twenty out of 23 NICU nurses attended educational sessions and
their assessment showed significantly improved post-test scores.
TABLE I Characteristics of the Study Population and Neonatal Unit in Phase-1 and Phase-3 of Study
Parameter |
Phase-1 (n=9) |
Phase-3 (n=11) |
P value |
Gestational age in weeks# |
30 (29, 31) |
28 (26, 30) |
0.16 |
Birthweight in grams* |
1088 (307) |
1035 (312) |
0.70 |
Male gender$ |
3 (33) |
4 (36) |
0.88 |
Appropriate for gestational age$ |
5 (55) |
8 (72) |
0.42 |
Singleton baby$ |
7 (78) |
9 (81) |
0.82 |
Complete steroid coverage$ |
6 (67) |
9 (82) |
0.43 |
Vaginal delivery$ |
2 (22) |
4 (36) |
0.45 |
Apgar score at 5 min# |
8 (7, 8) |
7 (6, 8) |
0.08 |
CRIB II score# |
8 (3, 8) |
7.5 (4, 10) |
0.13 |
Need for surfactant$ |
6 (66) |
9 (82) |
0.4 |
NICU characteristics (Nursing shifts analyzed) |
138 |
133 |
|
Nurse’s strength/ shift# |
4 (4, 5) |
4 (4, 5) |
0.66 |
Number of neonates in NICU/shift# |
7 (6, 7) |
6 (5, 7) |
<0.001 |
Number of neonates on non-invasive mode/shift#
|
2 (2, 3) |
1 (1, 2) |
0.01 |
Number of babies on mechanical ventilation/shift#
|
1 (0, 2) |
2 (1, 3) |
<0.001 |
Values are expressed *mean (SD), #median (IQR),
or $n (%); CRIB II: Clinical risk index for babies
score. |
The mean (SD) percent time spent within target
saturation range increased from 65.9% (21.4) to 76.5% (12.6) (P=0.001)
(Table II). The percentage of time spent in hyperoxic
range decreased significantly but we noted an increase in hypoxic time
from 6.7% (5.7) to 11% (8.7) in phase-3. However, the percent time below
significant hypoxia (SpO2 <80%) did not increase.
TABLE II Percentage of Time Spent per Epoch Within, Above and Below the Target Saturation Range
Outcome |
Phase-1 |
Phase-3 |
P value |
Change from |
|
Epochs (N=48) |
Epochs (N= 69) |
(95% CI) |
Phase-1 |
Time per epoch (%) |
Within the target saturation range (SpO2 88-95%) |
65.9 (21.4) |
76.5 (12.6) |
0.001 |
10.6(4.3 to16.8) |
Above the target saturation (SpO2 >95%) |
27.3 (22.7) |
12.5 (13.8) |
<0.001 |
-14.8(-12.6 to -8.2) |
Below target saturation (SpO2 <88%) |
6.7 (5.7) |
11.0 (8.7) |
0.003 |
4(1.4 to 7.1) |
Less than 80% |
2.0 (2.2) |
2.6 (2.9) |
0.18 |
0.6(-0.3 to 1.6) |
Value in mean (SD). |
On adjusted analysis using GEE, the improved
compliance within the target range and reduction in hyperoxia was
statistically significant (Web Table I). The temporal
distribution of saturation of enrolled neonates using a density
histogram (Web Fig. 2) showed a shift away
from hyperoxia but towards the hypoxia side in phase-3 compared to
phase-1.
There was no difference in clinical outcomes like
bronchopulmonary dysplasia, ROP or mortality in either phase. Five
neonates (45%) had patent ductus arteriosus (PDA) requiring therapy in
phase-3 compared to none in phase-1 (P=0.03).
Discussion
This QI study demonstrated better oxygen saturation
targeting and reduction in hyperoxic period after implementation of unit
policy on oxygen administration.
Many units have demonstrated improved oxygen
targeting using strategies like implementing written unit policy on SpO 2
targets [2,3], practice change models/QI initiatives [4-7] like
educating caregivers on the hazards of hypo and hyperoxia and
implementing guidelines for adjusting fraction of inspired oxygen (FiO2).
Our baseline compliance is similar to an earlier report [8]. Oxygen
saturation histograms for feedback has been used in some earlier studies
[9,10] in addition to other strategies but failed to demonstrate
significant improvement in oxygen targeting.
The limitations of our study include: (i) the
interventions namely staff education and visual reminders were
introduced over 4 weeks followed by use of histograms in next 6 weeks.
We did not study the impact of each of these interventions in a stepwise
PDSA- based approach mainly because of the difficulties involved in
pulse-oximeter data retrieval and analysis; (ii) while we could
analyze adequate epochs for study purpose, only 20 neonates were
enrolled that limits the repertoire of cases. The study was not
adequately powered to detect differences in clinical outcomes; hence the
higher incidence of PDA in phase-3 needs further investigation; and (iii)
possibility of Hawthorne effect of nurses being observed cannot be ruled
out.
The ideal method of oxygen targeting is a bedside
nurse with a single patient assignment who can maintain SpO 2
within the target range by making manual FiO2
adjustments [8]. In a busy unit where nurses have high workload and
multiple responsibilities, such dedicated attention becomes difficult.
This QI study shows that with the available equipment and nursing
strength, it is possible to improve oxygen targeting by implementing a
written policy through staff education. In order to sustain the
improvement, we continue to use visual reminders, periodic checks on
pulse-oximeter alarm settings, and regular in-service education. Use of
saturation histograms for regular feedback is possible only with the
help of pulse-oximeters with built-in program and needs to be explored
further.
Contributors: SS: concept, implementation, data
collection, analyses and drafted the manuscript; TS: data collection and
data analysis; RL: supervised data collection, analyses and manuscript
writing; AT, MJS and RA: concept and design, implementation and
manuscript writing; VKP: concept and study design, AKD: concept, design,
supervised implementation and manuscript writing.
Funding: TS received grant from Wellcome
Trust/DBT India Alliance (Grant IA/CPHE/14/1/501504); Competing
Interest: None stated.
What This Study Adds?
• Compliance with oxygen targeting can be
improved by effective implementation of unit policy on oxygen
administration by staff education and feedback using saturation
histograms.
|
References
1. Stenson BJ. Oxygen saturation targets for
extremely preterm infants after the NeOProM Trials. Neonatol.
2016;109:352-8.
2. Vijayakumar E, Ward GJ, Bullock CE, Patterson ML.
Pulse oximetry in infants of <1500 gm birth weight on supplemental
oxygen: A national survey. J Perinatol. 1997;17:341-5.
3. Hagadorn JI, Furey AM, Nghiem TH, Schmid CH,
Phelps DL, Pillers DA, et al. Achieved versus intended pulse
oximeter saturation in infants born less than 28 weeks’ gestation: the
AVIOx study. Pediatrics. 2006;118: 1574-82.
4. Ford SP, Leick-Rude MK, Meinert KA, Anderson B,
Sheehan MB, Haney BM, et al. Overcoming barriers to oxygen
saturation targeting. Pediatrics. 2006;118:S177-86.
5. Chow LC, Wright KW, Sola A, CSMC Oxygen
Administration Study Group. Can changes in clinical practice decrease
the incidence of severe retinopathy of prematurity in very low birth
weight infants? Pediatrics. 2003;111:339-45.
6. Coe K, Butler M, Reavis N, Klinepeter ME, Purkey
C, Oliver T, et al. Special Premie Oxygen Targeting (SPOT): A
program to decrease the incidence of blindness in infants with
retinopathy of prematurity. J Nurs Care Qual. 2006;21:230-5.
7. Ellsbury DL, Ursprung R. Comprehensive oxygen
manage-ment for the prevention of retinopathy of prematurity: The
pediatrix experience. Clin Perinatol. 2010;37:203-15.
8. Claure N, Gerhardt T, Everett R, Musante G,
Herrera C, Bancalari E. Closed-loop controlled inspired oxygen
concentration for mechanically ventilated very low birth weight infants
with frequent episodes of hypoxemia. Pediatrics. 2001;107:1120-4.
9. Laptook AR, Salhab W, Allen J, Saha S, Walsh M.
Pulse oximetry in very low birth weight infants: Can oxygen saturation
be maintained in the desired range? J Perinatol. 2006;26:337-41.
10. Arawiran J, Curry J, Welde L, Alpan G. Sojourn
in excessively high oxygen saturation ranges in individual, very low-birthweight
neonates. Acta Paediatr. 2015;104:e51-6.
|
|
|
|