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低预测肺功能患者的预防性气管切开术与肺癌切除术:一项随机临床试验

Prophylactic tracheotomy and lung cancer resection in patient with low predictive pulmonary function: a randomized clinical trials.

作者信息

Filaire Marc, Tardy Marie M, Richard Ruddy, Naamee Adel, Chadeyras Jean Baptiste, Da Costa Valence, Bailly Patrick, Eisenmann Nathanaël, Pereira Bruno, Merle Patrick, Galvaing Géraud

机构信息

Department of Thoracic Surgery, Jean Perrin Cancer Center, 58 Rue Montalembert, BP 392, 63011 Clermont-Ferrand, France.

Departement of Thoracic Surgery, Jean Perrin Cancer Center, 63011 Clermont-Ferrand, France.

出版信息

Chin Clin Oncol. 2015 Dec;4(4):40. doi: 10.3978/j.issn.2304-3865.2015.11.05.

DOI:10.3978/j.issn.2304-3865.2015.11.05
PMID:26730752
Abstract

BACKGROUND

Whether prophylactic tracheotomy can shorten the duration of mechanical ventilation (MV) in high risk patients eligible for lung cancer resection. The objective was to compare duration of MV and outcome in 39 patients randomly assigned to prophylactic tracheotomy or control.

METHODS

Prospective randomized controlled, single-center trial (ClinicalTrials.gov Identifier: NCT01053624). The primary outcome measure was the cumulative number of MV days after operation until discharge. The secondary outcome measures were the 60 days mortality rate, the ICU and the hospital length of stay, the incidence of postoperative respiratory, cardiac and general complications, the reventilation rate, the need of noninvasive ventilation (NIV), the need of a tracheotomy in control group and the tracheal complications.

RESULTS

The duration of MV was not significantly different between the tracheotomy group (3.5±6 days) and the control group (4.7±9.3 days) (P=0.54). Among patients needing prolonged MV >4 days, tracheotomy patients had a shortened duration of MV than control patients (respectively 11.4±7.1 and 20.4±9.6 days, P=0.04). The rate of respiratory complications were significantly lower in the tracheotomy group than in the control group (28% vs. 51%, P=0.03). Six patients (15%) needed a postoperative tracheotomy in the control group because of a prolonged MV >7 days. Tracheotomy was associated with a reduced need of NIV (P=0.04). There was no difference in 60-day mortality rate, cardiac complications, intensive care unit and hospital length of stay. No death was related with the tracheotomy.

CONCLUSIONS

Prophylactic tracheotomy in patients with ppo FEV1 <50% who underwent thoracotomy for lung cancer resection provided benefits in terms of duration of prolonged MV and respiratory complications but was not associated with a decreased mortality rate, ICU and hospital length of stay and non-respiratory complications.

摘要

背景

对于适合肺癌切除的高危患者,预防性气管切开术是否能缩短机械通气(MV)时间。目的是比较39例随机分配至预防性气管切开术组或对照组患者的MV时间及结局。

方法

前瞻性随机对照单中心试验(ClinicalTrials.gov标识符:NCT01053624)。主要结局指标为术后直至出院的MV天数累计值。次要结局指标为60天死亡率、重症监护病房(ICU)及住院时间、术后呼吸、心脏及全身并发症发生率、再通气率、无创通气(NIV)需求、对照组气管切开需求及气管并发症。

结果

气管切开术组(3.5±6天)与对照组(4.7±9.3天)的MV时间无显著差异(P=0.54)。在需要延长MV>4天的患者中,气管切开术患者的MV时间短于对照组患者(分别为11.4±7.1天和20.4±9.6天,P=0.04)。气管切开术组的呼吸并发症发生率显著低于对照组(28%对51%,P=0.03)。对照组中有6例患者(15%)因MV延长>7天而需要术后气管切开术。气管切开术与NIV需求减少相关(P=0.04)。60天死亡率、心脏并发症、ICU及住院时间无差异。无死亡与气管切开术相关。

结论

对于ppo FEV1<50%且接受开胸肺癌切除术的患者,预防性气管切开术在延长MV时间和呼吸并发症方面有获益,但与死亡率降低、ICU及住院时间以及非呼吸并发症无关。

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