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Randomized controlled trial on the comparison of chest tube drainage and needle aspiration in the treatment of primary spontaneous pneumothorax.

ABSTRACT: Objectives:To evaluate the efficacy of the chest tube drainage (CTD) and the needle aspiration (NA) in the treatment of primary Spontaneous pneumothorax (SP). Methods:In a randomized controlled trial, seventy patients suffering SP were divided equally into two subgroups, as follows: (A) CTD and (B) NA. The immediate and one-week rate of the treatments was the primary endpoints. Postoperative complications, length of hospital stay and incidence of pneumothorax recurrence during one-year follow up were also recorded. Results:The immediate success of treatment was 68.5% and 54.2% of patients in CTD and NA groups, respectively that showed no significant difference between study groups (P: 0.16). The complete lung expansion after one week observed in 32 (91.4%) of NA group and 33 (94.2%) patients in CTD group (P: 0.5). Pneumothorax recurrence was detected in 13 patients (4 in NA and 9 in CTD group) (P: 0.11). Mean pain intensity was significantly lower in the NA group at the first hour after the procedure, the first postoperative day and the first week after the intervention (P< 0.001). Conclusion:Needle aspiration (NA) can be applied as a first step treatment in patients with primary SP, considering its advantages.

SUBMITTER: Ramouz A

PROVIDER: S-EPMC6290202 | biostudies-literature | 2018 Nov-Dec

REPOSITORIES: biostudies-literature

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Randomized controlled trial on the comparison of chest tube drainage and needle aspiration in the treatment of primary spontaneous pneumothorax.

Ramouz Ali A Lashkari Mohammad Hossein MH Fakour Sanam S Rasihashemi Seyed Ziaeddin SZ

Pakistan journal of medical sciences 20181101 6

<h4>Objectives</h4>To evaluate the efficacy of the chest tube drainage (CTD) and the needle aspiration (NA) in the treatment of primary Spontaneous pneumothorax (SP).<h4>Methods</h4>In a randomized controlled trial, seventy patients suffering SP were divided equally into two subgroups, as follows: (A) CTD and (B) NA. The immediate and one-week rate of the treatments was the primary endpoints. Postoperative complications, length of hospital stay and incidence of pneumothorax recurrence during one ...[more]

PMID: 30559787

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Project description:Importance:Treatment options for a symptomatic pneumothorax in newborns include needle aspiration (NA) and chest drain (CD) insertion. There is little consensus as to the preferred treatment, reflecting a lack of evidence from clinical trials. Objective:To investigate whether treating pneumothoraces diagnosed on chest radiography (CR) in newborns receiving respiratory support with NA results in fewer infants having CDs inserted within 6 hours of diagnosis. Design, Setting, and Participants:This randomized clinical trial was conducted from October 7, 2013, to December 21, 2016. The setting was 5 tertiary European neonatal intensive care units. Infants receiving respiratory support (endotracheal ventilation, continuous positive airway pressure, or supplemental oxygen >40%) who had a pneumothorax on CR that clinicians deemed needed treatment were eligible for inclusion. Interventions:Infants were randomly assigned (1:1) to drainage using NA or CD insertion, stratified by center and gestation at birth (<32 vs ?32 weeks). Caregivers were not masked to group assignment. For NA, a needle was inserted between the ribs to aspirate air and was removed once air was no longer aspirated. A CD was inserted if clinicians deemed that the response was inadequate. For CD insertion, a drain was inserted between the ribs and was left in situ. Main Outcomes and Measures:The primary outcome was whether a CD was inserted on the side of the pneumothorax within 6 hours of diagnosis. Results:A total of 76 infants were randomly assigned, and 6 (4 assigned to NA and 2 to CD) were excluded because they met exclusion criteria at enrollment. Of the 70 remaining infants, 33 (16 male [48%]) were assigned to NA and 37 (22 male [59%]) to CD insertion. Their median (interquartile range [IQR]) gestational age was 31 (27-38) vs 31 (27-35) weeks, and their median (IQR) birth weight was 1385 (1110-3365) vs 1690 (1060-2025) g, respectively. Fewer infants assigned to NA had a CD inserted within 6 hours (55% [18 of 33] vs 100% [37 of 37]; relative risk, 0.55; 95% CI, 0.40-0.75) and during hospitalization (70% [23 of 33] vs 100% [37 of 37]; relative risk, 0.70, 95% CI, 0.56-0.87). Conclusions and Relevance:Needle aspiration reduced the rate of CD insertion in symptomatic newborns with pneumothorax on CR. It should be used as the initial method of draining radiologically confirmed pneumothorax in symptomatic infants. Trial Registration:isrctn.org Identifier: ISRCTN65161530.

Project description:BackgroundPrimary spontaneous pneumothorax occurs in otherwise healthy young patients. Optimal management is not defined and often results in prolonged hospitalisation. Data on efficacy of ambulatory options are poor. We aimed to describe the duration of hospitalisation and safety of ambulatory management compared with standard care.MethodsIn this open-label, randomised controlled trial, adults (aged 16-55 years) with symptomatic primary spontaneous pneumothorax were recruited from 24 UK hospitals during a period of 3 years. Patients were randomly assigned (1:1) to treatment with either an ambulatory device or standard guideline-based management (aspiration, standard chest tube insertion, or both). The primary outcome was total length of hospital stay including re-admission up to 30 days after randomisation. Patients with available data were included in the primary analysis and all assigned patients were included in the safety analysis. The trial was prospectively registered with the International Standard Randomised Clinical Trials Number, ISRCTN79151659.FindingsOf 776 patients screened between July, 2015, and March, 2019, 236 (30%) were randomly assigned to ambulatory care (n=117) and standard care (n=119). At day 30, the median hospitalisation was significantly shorter in the 114 patients with available data who received ambulatory treatment (0 days [IQR 0-3]) than in the 113 with available data who received standard care (4 days [IQR 0-8]; p<0·0001; median difference 2 days [95% CI 1-3]). 110 (47%) of 236 patients had adverse events, including 64 (55%) of 117 patients in the ambulatory care arm and 46 (39%) of 119 in the standard care arm. All 14 serious adverse events occurred in patients who received ambulatory care, eight (57%) of which were related to the intervention, including an enlarging pneumothorax, asymptomatic pulmonary oedema, and the device malfunctioning, leaking, or dislodging.InterpretationAmbulatory management of primary spontaneous pneumothorax significantly reduced the duration of hospitalisation including re-admissions in the first 30 days, but at the expense of increased adverse events. This data suggests that primary spontaneous pneumothorax can be managed for outpatients, using ambulatory devices in those who require intervention.FundingUK National Institute for Health Research.

Project description:BackgroundManual aspiration as the initial management of a large pneumothorax in a clinically stable patient has been reported to be safe and effective. However, the effect with smaller needles, the number of aspiration, the indication other than spontaneous pneumothorax and failure factors are unknown. We assessed the effectiveness and failure risk factors of manual aspiration up to three using a 20- or 22-gauge (G) needle in patients with a large, clinically stable pneumothorax.MethodsWe included 107 clinically stable patients with large pneumothorax. Patients who were unstable, required a ventilator, underwent chest tube drainage or had an observed small pneumothorax, bilateral pneumothorax, hemopneumothorax, or postoperative pneumothorax were excluded. Up to three aspirations were performed using 20- or 22-G intravenous needles. When the aspiration volume was ≥2,500 mL or lung expansion did not occur, a chest tube was placed.ResultsThe first aspiration was successful in 57 patients (53.3%), the second in 16 patients (59.3%), and the third in eight patients (80.0%). No patient experienced any obvious complications or required emergent hospitalization or surgery after aspiration. Aspiration failure was correlated with an inter-pleural distance >20 mm at the level of the hilum [odds ratio (OR): 4.93; 95% confidence interval (CI): 1.49-22.71; P=0.0075], spontaneous secondary pneumothorax (OR: 3.11; 95% CI: 1.14-8.76; P=0.027), and ≤24 h from onset to presentation (OR: 2.95; 95% CI: 1.12-8.26; P=0.028). There were no significant differences in intrathoracic pressure after aspiration or plasma factor XIII levels between patients with resolved and persistent pneumothorax.ConclusionsManual aspiration up to three times using a small needle might be one of a treatment option in clinically stable patients with any large pneumothorax. Aspiration failure was correlated with an inter-pleural distance >20 mm at the level of the hilum, spontaneous secondary pneumothorax, and ≤24 h from onset to presentation.

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Randomized controlled trial on the comparison of chest tube drainage and needle aspiration in the treatment of primary spontaneous pneumothorax.

Publications

Randomized controlled trial on the comparison of chest tube drainage and needle aspiration in the treatment of primary spontaneous pneumothorax.

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