Use of a modified bubble continuous positive airway pressure (bCPAP) device for children in respiratory distress in low- and middle-income countries: a safety study

Figures & data

Table 1. Modified TAL clinical score [22,23].

Score	Respiratory rate/min <6 mths	Respiratory rate/min ≥6 mths		Wheezing	Cyanosis	Accessory muscle use
0	≤40	≤30		None	None	None
1	41–55	31–45		End expiratory with stethoscope	Peri-oral with crying	+
2	56–70	46–60		Inspiration and expiration with stethoscope	Peri-oral at rest	++
3	>70	>60		Audible without stethoscope	Generalised at rest	+++
Respiratory distress category			Total score
Mild			0–3
Moderate			4–8
Severe			9–12

Figure 1. (A) SEAL-bCPAP set-up (device constructed from oxygen tubing, nasal cannula, plastic water bottle and tape/glue); (B). Nasal prong adaptation with ear-plug material.

Table 2. Severity of illness.

Level	TAL score	O2sat	Illness severity criteria
Mild	4–5	≥90%	Both TAL and O2sat mild
Moderate	6–7	85–<90%	Either TAL or O2sat moderate, neither severe
Severe	≥8	<85%	Either TAL or O2sat severe
			If either TAL score or O2sat missing, then severity is based on the non-missing value

Table 3. Baseline (Time1*) characteristics.

Baseline characteristic	Pre-trial	BUBBLES trial	p-value^†
	n=49	n=83
Gender, n (%)			0.83
Male	25 (51)	44 (53)
Female	24 (49)	39 (47)
Age, yrs, mean (SD)	1.8 (1.4)	1.3 (1.3)	0.06
Time1 RR^‡ , mean (SD)	55.8 (13.6)	64.4 (15.2)	0.002
		Missing for 4
Time1 O2sat, mean (SD)	90.0 (10.5)	79.4 (12.9)	<0.0001
	Missing for 2	Missing for 1
Time1 TAL score, mean (SD)	5.0 (1.0)	7.0 (1.5)	<0.0001
Range	3–8 (a)	4–11
Time1 illness severity, n (%)			<0.0001
Mild	25 (51.0)	3 (3.6)
Moderate	12 (24.5)	16 (19.3)
Severe	12 (24.5)	64 (77.1)

* Time 1, baseline data at first examination; prior to any intervention.

† p-values are for the χ² test for proportions and two-sample t-test for means.

‡ respiratory rate (a) one patient with TAL = 3 had O₂sat = 91. p-values in bold type are statistically significant.

Table 4. Trial patients Time1 (before SEAL-bCPAP) vs Time2 (two hours after SEAL-bCPAP commenced).

Measure	Time1	Time2	Mean (SE)	p-values*
	Mean (SD)	Mean (SD)	change
TAL score	7.0 (1.5)	5.6 (1.6)	−1.4 (0.17)	<0.0001
Respiratory rate	64.4 (15.2)	54.5 (17.1)	−9.4 (1.6)	<0.0001
Oxygen saturation	79.4 (12.9)	94.6 (8.5)	15.1 (1.6)	<0.0001
Illness severity	Time1	Time2
	n (%)	n (%)
None	0	6 (7.2)
Mild	3 (3.6)	26 (31.3)
Moderate	16 (19.3)	39 (47.0)
Severe	64 (77.1)	12 (14.5)
TAL severity
<8	49 (59.0)	74 (89.2)
≥8	34 (41.0)	9 (10.8)

* p-value for paired t-test of mean change.

Table 5. Illness severity at Time1 and Time2 in trial and pre-trial patients.

	Pre-trial		BUBBLES trial
Illness severity	Time 1	Time 2	Time 1	Time 2
	n = 49 (%)	n = 44 (%)	n = 83 (%)	n = 83 (%)
None	0	13 (29.6)	0	6 (7.2)
Mild	25 (51)	19 (43.2)	3 (3.6)	26 (31.3)
Moderate	12 (24.5)	4 (9.1)	16 (19.3)	39 (47.0)
Severe	12 (24.5)	8 (18.2)	64 (77.1)	12 (14.5)