Table 4.
Summery of included studies
| Author | Year | Design | Study objects | Timing of measurement | Target range | Key results |
|---|---|---|---|---|---|---|
| Armbruster, J. et al. | 2010 | Qualitative study with individual open-ended interviews | 41 nurses | First 3 days of life while infants were receiving supplemental oxygen | 88–92 % | Saturations of infants in the Canadian Oxygen Trial (COT) study were in the intended range in 68–79 % of time. Nurses identified education, prompt response to alarm limits and a favourable patient to staff ratio as important determinants of good compliance |
| Claure, N. et al. | 2009 | Pilot clinical trial | 16 premature infants, GA 24.9 ± 1.4 weeks receiving mechanical ventilation and FiO2 | 4-h period with FiO2 adjustment by clinical staff members (manual) and 4-h period with automated FiO2 adjustments (automated) PNA 33 days (SD ± 15) |
88–95 % | In automated mode: • % of time within SpO2 target range was 58 % • % of time that SpO2 >95 % was 9 % • % of time that SpO2 <88 % was 33 % In manual mode: • % of time within SpO2 target range was 42 % • % of time that SpO2 >95 % was 31 % • % of time that SpO2 <88 % was 27 % |
| Claure, N. et al. | 2001 | Efficacy study | 14 infants, GA 25 weeks (SD ±1.6) receiving mechanical ventilation and FiO2 | 2 h in manual FiO2 mode and 2 h in automatic FiO2 mode in random sequence. PNA 26 days (SD ± 11) |
88–96 % | In automatic FiO2 mode • % of time within SpO2 target range was 74.9 % • The percentage of time that saturations were <88 % was 16.5 % and • >96 % in 9.9 % of the time. In manual FiO2 mode • % of time within SpO2 target range was 66.3 % • The percentage of time that saturations <88 % was 18.7 % and • >96 % in 14.9 % of time. |
| Claure, N. et al. | 2011 | Clinical trial | 32 premature infants GA 25 weeks (24–27) receiving mechanical ventilation and FiO2 | 24-h period with FiO2 adjustment by clinical staff members (manual) and 24-h period with automated FiO2 adjustments (automated) PNA 27 days (range 17–36) |
87–93 % | In automated mode: • % of time within SpO2 target range was 40 % • % of time that SpO2 >93 % was 28 % • % of time that SpO2 <87 % was 32 % In manual mode: • % of time within SpO2 target range was 32 % • % of time that SpO2 >93 % was 43 % • % of time that SpO2 <87 % was 23 % |
| Clucas, L. et al. | 2007 | Prospective cohort study | 80 infants with receiving supplemental oxygen Mean GA of 28.4 weeks (SD ±2.4) 1073 lower and upper alarm limit values |
Daily during weekdays, when the infant was on oxygen until discharge PNA 5 days (IQR 2–34.5) |
88–92 % | The lower alarm limit was set correctly in 91.1 % of the time, 6.3 % was set lower, and 2.7 % was set higher than intended; upper alarm limit was set correctly in 23.3 % of the time, 0.2 % was set lower, and 76.5 % was set higher than intended. |
| Hagadorn, J.I. et al. | 2006 | Prospective multicentre cohort study | 84 infants GA 26.3 Median: (29.4–27.4) 14 centres from three counties 307 monitor periods of median duration of 67.3 h |
Saturation for 72 h each week for the first 4 weeks of life | Centre-specific intended TR 92–96 % 90–95 % 88–95 % 88–97 % 88–92 % 87–94 % 92–96 % 90–96 % 85–98 % 88–94 % 85–94 % 88–92 % 83–93 % |
Overall, infants spent 16 % below intended range and 36 % above their NICU’s intended range |
| Laptook, A.R. et al. | 2006 | Prospective observational study | Group 1: 23 infants GA 27 weeks (±2) receiving continuous supplemental oxygen (with or without ventilator) Group 2: 49 infants, GA 26 weeks (±2) receiving continuous supplemental oxygen (with or without ventilator) |
24 h of data twice a month during 6 months when the author was available PNA group 1, 23 days (±21) PNA group 2, 23 days (±19) |
Group 1: target range 90–95 %, Group 2: target range 88–94 % |
Group 1: SpO2 values were under target range in 26.9 % and above the target range in 15.4 % of time Group 2: SpO2 values were under target range in 26.6 % and above the target range in 14.0 % of time |
| Mills, B.A. et al. | 2010 | Prospective cohort study | 56 infants mean GA 26.7 weeks (SD 2.0) receiving supplemental oxygen 22 infants in BOOST II trial Number of recordings = 454 |
Daily during weekdays, when the infant was on oxygen until discharge | 88–92 % | Lower alarm limits: In BOOST II trial; 94.2 % was set correctly; Not in BOOST II; 87.3 % was set correctly. Upper alarm limits: In BOOST II trial; 79.8 % was set correctly; Not in BOOST II; 28.8 % was set correctly |
| Nghiem, T.H. et al. | 2008 | Survey | 59 NICUs 2805 nurses who submitted surveys |
First 4 weeks of life of preterm infants | 68 % of included NICUs, had policy specified SpO2 target limits; not exactly defined | Of 1957 nurses at NICUs with policies, 64 % of nurses were aware that policy for SpO2 was present in their NICU. 715 (37 %) nurses correctly identified the SpO2 limits specified by their NICU policy |
| Sink, D.W. et al. | 2011 | Retrospective observational study | 14 infants GA <26.6 weeks (SD ± 1.6) with oximeter data 87 nurses |
Every 2 s during routine bedside oximetry monitoring PNA 31.6 weeks (mean range 24.1–40.7 weeks) |
85–92 % | Oxygen saturations in infants <28 GA were 61 % above intended range and 6 % under de intended range. Infants of 28–31 weeks of gestation were 70 % above intended range and 7 % under de intended range. Hyperoxic time increased from 48 to 71 % with assignment of a second patient to the infant’s nurse and to 82 % with assignment of a third patient to the infant’s nurse |
| Urschitz, M.S. et al. | 2004 | Randomized controlled clinical trial (validation and efficacy trial) | Validation trial: 12 preterm infants GA; median (IQR) 24.5 (24–28) receiving ventilator support and FiO2 Efficacy trial; 12 preterm infants GA; median (IQR) 25.5 (24–33) receiving ventilator support and FiO2 |
1 day during five periods of different modes, 90 min in each mode • Baseline 1, • Routine manual control, • Optimal manual control, • Closed-loop control, • Baseline 2 Validation trial: PNA 21 days (median range 8–57) Efficacy trial: PNA 20.5 days (median range 4–78) |
87–96 % | Validation trial: % of time within SpO2 target range was • Baseline 1, 75.3 % • Routine manual control, 79.7 % • Optimal manual control, 85.8 % • Closed-loop control, 82.1 % • Baseline 2, 79.4 % No information over hypoxaemic and hyperoxaemic periods Efficacy trial: % of time within SpO2 target range was • Baseline 1, 82.9 % • Routine manual control, 81.7 % • Optimal manual control, 91 % • Closed-loop control, 90.5 % • Baseline 2, 81.2 % Duration of hypoxic episodes • Baseline 1, 20.2 s (11.3 %) • Routine manual control, 19 s (10.7 %) • Optimal manual control, 16.4 s (9.2 %) • Closed-loop control, 12.4 s (7 %) • Baseline 2, 19.1 s (10.7 %) Duration of hyperoxic episodes • Baseline 1, 24.7 s (6.7 %) • Routine manual control, 19.3 s (5.2 %) • Optimal manual control, 16.4 s (5 %) • Closed-loop control, 10.1 s (2.7 %) • Baseline 2, 17.4 s (4.7 %) |
| Van der Eijk, A.C. et al. | 2012 | Observational cohort study | 12 infants, median GA 26 2/7 weeks (range 24 2/7–28) with a need for supplemental oxygen | Recording started when FiO2 was >21 % in the first 2 weeks of life PNA 4 days (range 2–12) |
88–94 % | SpO2 <88 % in 16 % of the time and >94 % in 30 % of the time |
| Zapata, J. et al. | 2014 | Pilot clinical trial | 20 infants, mean GA 27.3 ± 1.7 vs 27.7 ± 1.7 weeks receiving supplemental oxygen by nasal cannula |
12-h study period PNA 5–14 days |
85–93 % | With automixer: • % of time within SpO2 target range was 58 % • % of time that SpO2 >95 % was 26.5 % • % of time that SpO2 <85 % was 14 % In manual routine care: • % of time within SpO2 target range was 33.7 % • % of time that SpO2 >95 % was 54.8 % • % of time that SpO2 <85 % was 11.5 % |
| Hallenberger, A. et al. | 2014 | Multicenter randomized controlled crossover clinical trial | 34 infants median GA (range) 26.4 (23.0–35.3) receiving mechanical ventilation or nasal CPAP and supplemental oxygen | 24-h period with routine manual control (RMC) and 24-h period with closed-loop automated control (CLAC) PNA 29.9 weeks (26.0–35.6) (median (range)) |
Four centre-specific TRs 90–95 % 80–92 % 83–93 % 85–94 % |
In closed-loop automated control (CLAC): • % of time within SpO2 target range was 72.1 (13.6) (mean(SD)) • % of time that SpO2 above TR was 15.9 (1.9–34.8) (median (range)) • % of time that SpO2 below TR was 9.1 (1.9–24.2) (median (range)) In routine manual control (RMC): • % of time within SpO2 target range was 61.0 (15.2) (mean(SD)) • % of time that SpO2 above TR was 16.0 (0.0–60.0) (median (range)) • % of time that SpO2 below TR was 15.0 (0.5–39.6) (median (range)) |
| Arawiran, J. et al. | 2014 | Prospective observational cohort study | 71 premature infants GA <31 weeks Pre-intervention phase: 41 infants: 25 ± 1.6 weeks (mean ± SD) Postintervention phase: 30 infants: 25 ± 1.9 weeks (mean ± SD) |
Study period from first day of life as long as they received supplemental oxygen or were taken off the Masimo monitors or reached 31 weeks postconceptual age, whichever occurred first | 85–92 % | Pre-intervention phase: • Proportion of time spent per 12-h shift in which individual babies were (mean (%) ± SD (%)) • <70 % was 3.4 ± 2.6 • 70–74 % was 1.6 ± 1.3 • 75–79 % was 4.0 ± 2.9 • 80–84 % was 9.6 ± 5.63 • 85–92 % was 44.5 ± 14.4 • 93–100 % was 36.9 ± 17.2 Postintervention phase: • Proportion of time spent per 12-h shift in which individual babies were (mean (%) ± SD (%)) • <70 % was 3.3 ± 2.5 • 70–74 % was 1.6 ± 1.1 • 75–79 % was 3.9 ± 2.3 • 80–84 % was 8.9 ± 4.3 • 85–92 % was 40.4 ± 12.8 • 93–100 % was 41.9 ± 15.6 |
| Lim, K. et al. | 2014 | Multicenter prospective observational cohort study | 45 premature infants GA 30 (IQR 27–32 weeks) 2971 h receiving supplemental oxygen |
Age at first recording was at day 1 (IQR 0–8 days) | 88–92 % | Median proportion of time in % ((IQR)) • % of time within SpO2 target range was 31 % (19–39) • % of time that SpO2 >93 % was 59 % (36–74) • % of time that SpO2 <87 % was 9 % (4.3–18) More than one infant per nurse was associated with a greater frequency of significant hyperoxaemia (SpO2 >98 %) when infants were in supplemental oxygen, and a trend towards less normoxaemia |