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在重症监护环境中,比较有套囊与无套囊的气管导管在婴儿中的疗效和安全性:一项先导、非盲随机对照试验。

Comparison of the efficacy and safety of cuffed versus uncuffed endotracheal tubes for infants in the intensive care setting: a pilot, unblinded RCT.

机构信息

Department of Neonatology, Perth Children's Hospital, Nedlands, Western Australia, Australia

Department of Paediatric Critical Care, Perth Children's Hospital, Nedlands, Western Australia, Australia.

出版信息

Arch Dis Child Fetal Neonatal Ed. 2021 Nov;106(6):614-620. doi: 10.1136/archdischild-2020-320764. Epub 2021 Apr 20.

DOI:10.1136/archdischild-2020-320764
PMID:33879529
Abstract

OBJECTIVE

To study effectiveness and safety of cuffed versus uncuffed endotracheal tubes (ETTs) in small infants in the intensive care unit (ICU).

DESIGN

Pilot RCT.

SETTING

Neonatal and paediatric ICUs of children's hospital in Western Australia.

PARTICIPANTS

Seventy-six infants ≥35 weeks gestation and infants <3 months of age, ≥3 kg.

INTERVENTIONS

Patients randomly assigned to Microcuff cuffed or Portex uncuffed ETT.

MAIN OUTCOMES MEASURES

Primary outcome was achievement of optimal ETT leak in target range (10%-20%). Secondary outcomes included: reintubations, ventilatory parameters, ventilatory complications, postextubation complications and long-term follow-up.

RESULTS

Success rate (achievement of mean leak in the range 10%-20%) was 13/42 (30.9%) in the cuffed ETT group and 6/34 (17.6%) in uncuffed ETT group (OR=2.09; 95% CI (0.71 to 6.08); p=0.28). Mean percentage time within target leak range in cuffed ETT group 28% (IQR: 9-42) versus 15% (IQR: 0-28) in uncuffed ETT group (p=0.01). There were less reintubations to optimise size in cuffed ETT group 0/40 versus 10/36 (p<0.001). No differences were found in gaseous exchange, ventilator parameters or postextubation complications. There were fewer episodes of atelectasis in cuffed ETT group 0/42 versus 4/34 (p=0.03). No patient had been diagnosed with subglottic stenosis at long-term follow-up.

CONCLUSIONS

There was no difference in the primary outcome, though percentage time spent in optimal leak range was significantly higher in cuffed ETT group. Cuffed ETTs reduced reintubations to optimise ETT size and episodes of atelectasis. Cuffed ETTs may be a feasible alternative to uncuffed ETTs in this group of patients.

TRIAL REGISTRATION NUMBER

ACTRN12615000081516.

摘要

目的

研究小儿重症监护病房(ICU)中使用带套囊与不带套囊的气管内导管(ETT)对小婴儿的有效性和安全性。

设计

试点 RCT。

设置

西澳大利亚儿童医院的新生儿和儿科 ICU。

参与者

76 名≥35 周胎龄和<3 个月大、≥3kg 的婴儿。

干预

患者随机分配至 Microcuff 带套囊或 Portex 不带套囊的 ETT。

主要结局测量

主要结局为达到目标范围内(10%-20%)的最佳 ETT 泄漏。次要结局包括:重新插管、通气参数、通气并发症、拔管后并发症和长期随访。

结果

带套囊 ETT 组的成功率(达到平均泄漏范围在 10%-20%)为 13/42(30.9%),而无套囊 ETT 组为 6/34(17.6%)(OR=2.09;95%CI(0.71 至 6.08);p=0.28)。带套囊 ETT 组的平均套囊泄漏百分比时间为 28%(IQR:9-42),而无套囊 ETT 组为 15%(IQR:0-28)(p=0.01)。在带套囊 ETT 组中,有 0/40 例需要重新插管以优化套囊大小,而在无套囊 ETT 组中为 10/36 例(p<0.001)。两组在气体交换、通气参数或拔管后并发症方面均无差异。带套囊 ETT 组发生肺不张的次数更少,为 0/42 例,而无套囊 ETT 组为 4/34 例(p=0.03)。长期随访时,无患者被诊断为声门下狭窄。

结论

虽然带套囊 ETT 组的最佳泄漏范围内的时间百分比明显更高,但主要结局无差异。带套囊 ETT 可减少重新插管以优化 ETT 大小和肺不张的发生。在该组患者中,带套囊 ETT 可能是不带套囊 ETT 的可行替代方案。

试验注册号

ACTRN12615000081516。

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