A randomised controlled trial of biopsy forceps and cannula aspiration for transcervical chorionic villus sampling. A randomized study to assess two different techniques of aspiration while performing transabdominal chorionic villus sampling. Randomized clinical trial of transabdominal versus transcervical chorionic villus sampling methods. Effects of conventional physiotherapy, continuous positive airway pressure and non-invasive ventilatory support with bilevel positive airway pressure after coronary artery bypass grafting. Randomized trial comparing a radially expandable needle system with cutting trocars. Evaluation of the feasibility of a new method for performing chorion villus sampling. Randomized comparative trial between percutaneous longlines and peripheral cannulae in the delivery of neonatal parenteral nutrition. Paracervical block in incomplete abortion using manual vacuum aspiration: randomized clinical trial. Selective decontamination of subglottic area in mechanically ventilated patients with multiple trauma.
This trial compared two instruments for transcervical chorionic villus sampling (CVS).
                Randomised controlled trial.
                Regional university prenatal diagnosis and treatment centre.
                Two hundred women were randomised at 10(+0)-12(+6) weeks of gestation to transcervical CVS using cannula aspiration (CA) or biopsy forceps (BF).
                Women undergoing indicated CVS signed informed consent. Randomisation after decision to perform transcervical CVS.
                Primary outcome: the rise in maternal serum alpha-fetoprotein (alpha-FP). Secondary outcomes: (i) placental trauma (fetomaternal haemorrhage [FMH]); (ii) laboratory, procedure, and cytogenetic results and pregnancy outcomes; (iii) patient and operator satisfaction; and (iv) economic analyses. Analyses were performed by intention to treat.
                The -FP rise did not differ between groups; there was no other evidence of placental trauma. BF were better tolerated by women, provided culturable tissue, after fewer instrument passes, with greater ease and in less time. BF were associated with cost savings.
                Unlike -FP, other markers of FMH were unaltered, questioning the reliability of alpha-FP as an indicator of FMH. Compared with CA, transcervical BF caused comparable placental trauma, appeared to be similarly effective and safe and were preferred by operators and patients. The technique used to perform transabdominal chorionic villus sampling (CVS) is not standardized, but aspiration of villi is generally obtained by discontinuous vacuum created in a syringe, manually or by a hand-grip device. We evaluated the feasibility of a new method of performing CVS which employs a 4-mL Vacutainer connected to the needle, producing a continuous negative pressure.
                Two hundred pregnant women, whose gestational age ranged from 10 + 2 to 16 + 2 (mean, 12 + 1) weeks, entered the randomized study, which was powered to detect with 90% probability the absence of any difference in the size of chorionic samples obtained by using a 20-mL syringe with the vacuum obtained by a hand-grip device (Group 1) or by a vacutainer (Group 2). Four operators with different levels of experience performed all the procedures, which were done transabdominally using a freehand technique with a 20-gauge needle under ultrasound guidance.
                Maternal age, body mass index, gestational age and the way the needle was inserted within the chorion were similar in the two groups. The median amount of villi sampled was 20 mg, with no differences between the two groups. The rate of fetal loss was 1.7%. All losses occurred in women of Group 1 who had only one needle insertion. A second needle insertion was required more frequently while using the vacutainer.
                This new technique for performing transabdominal CVS uses a readily available device and is as effective as traditional sampling systems to aspirate villi. It has the advantage of being a one-operator procedure. The relative advantages and disadvantages of transabdominal (TA) and transcervical (TC) chorionic villus sampling (CVS) in terms of fetal risks and efficacy were evaluated in a clinical trial conducted on 1194 women randomized at 7-12 weeks' gestation. The results of the study indicate that, if any, the relative risk of fetal loss following either procedure is less than double that of the alternative technique when performed by a skilled operator. Overall, the fetal loss rate (spontaneous abortions following randomization, terminations of pregnancy, and perinatal deaths) is 16.5 and 15.5 per cent, respectively, among women allocated to TA- and TC-CVS. The two procedures are equally effective, although TA-CVS is associated with a significantly lower rate of repeat device insertions; on the other hand, a higher weight of chorionic tissue is obtained, on average, with TC-CVS. Bleeding is more common following TC-CVS, while peritoneal reaction developed only after TA-CVS. No diagnostic problems specifically related to one sampling technique were identified. Coronary artery bypass graft (CABG) surgery with the use of mammary arteries is associated with severe alteration of lung function parameters. The purpose of the present study was to compare the effect on lung function tests of conventional physiotherapy using incentive spirometry (IS) with non-invasive ventilation on continuous positive airway pressure (CPAP) and with non-invasive ventilation on bilevel positive airway pressure (BiPAP or NIV-2P), METHODS: Ninety-six patients were randomly assigned to 1 of 3 groups: NIV-2P (1 h/3 h), CPAP (1 h/3 h) and IS (20/2 h). Pulmonary function tests and arterial blood gases analyses were obtained before surgery. On the 1st and 2nd postoperative days, these parameters were collected together with cardiac output and calculation of venous admixture.
                For the 3 groups a severe restrictive pulmonary defect was observed during the 1st postoperative day. On the 2nd postoperative day, in opposition to IS, intensive use of CPAP and NIV-2P reduced significantly the venous admixture (P<0.001) and improved VC, FEV1 and PaO2 (P<0.01).
                We conclude that preventive use of NIV can be considered as an effective means to decrease the negative effect of coronary surgery on pulmonary function. Sharp trocar insertion for laparoscopic procedures carries with it increased risk for vascular and visceral complications and incisional hernia. In a trial, which randomized 87 patients to treatment with either sharp trocars or a radially expanding needle system with blunt dilator, results showed that with the latter system there was statistically improved patient assessment of pain, a lower complications rate, and shorter procedure time. In the group of patients randomized to treatment with conventional trocars, there were a total of six instrument-related adverse events (6/42): four cases (five incidences) of abdominal wall injuries and one small bowel perforation caused by a Veress needle. Of the 45 patients randomized to the blunt dilator/cannula treatment, there was one adverse event (1/45) that was unrelated to the blunt dilator/cannula system: Veress needle injury to abdominal vasculature. The radially expanding access system demonstrates statistically improved patient postoperative comfort and improved patient safety. This study aimed to evaluate the usefulness and safety of a new method for taking a placental biopsy.
                The procedures were performed using the traditional single needle technique (group 1) or the new method (group 2). In group 2, the piston was fixed in a simple metallic clip and the negative pressure was maintained in a continuous manner which was controlled with a three-way stopcock.
                Multiple uterine insertion was necessary in 14 cases (32.6%) in group 1 and five (11.9%) in group 2 (p < 0.05). The amount of chorionic tissue obtained was significantly higher in group 2 (19.1 +/- 15.0 mg vs. 33.9 +/- 17.4 mg p < 0.05). The abortion rates did not differ in either group.
                While using this technique, the operator is capable of performing the procedure without any assistance and of applying constant negative pressure only in the placenta. The advantageous outcomes are probably related to the size as well as the incessant fashion of the vacuum force. Percutaneously inserted central venous catheters (CVCs) are frequently used for parenteral nutrition (PN) in neonates. Catheter-related sepsis (CRS) is the most commonly reported complication. The aim of this study was to compare sepsis rates between neonates receiving PN by CVC and by peripheral cannula. Neonates were randomized to receive PN either by CVC or by peripheral cannula. Primary outcomes were sepsis rates and efficacy of PN delivery. Interim analysis (49 neonates) revealed no difference in sepsis rates (CVC group 46%, cannula group 40%, p = 0.57). There was a significant discrepancy in PN delivered (median deficit 3.2% in the CVC group, 10.3% in the cannula group, p=0.0014). After consideration of these findings the study was terminated. Conclusion: Because the trial was stopped early, small but clinically important differences in the rates of sepsis may have been missed. Neonates in the cannula group accrued significant deficits of PN owing to a lack of venous access. This may contribute to undernutrition in neonates. CVC can be advocated for PN administration, in that sepsis appears to be no higher than when using cannulae and delivery of nutrition is significantly better. To estimate the effectiveness of paracervical block in controlling pain among women treated with manual vacuum aspiration for an incomplete abortion
                A randomized clinical trial was conducted at Nuestra Señora de Altagracia, a maternal and perinatal referral hospital in the Dominican Republic. The sample size was based on a clinical difference of 1.5 points in the level of pain measured with the visual analog scale using 90% power and a sampling error of 0.04. Women who were at 12 weeks of gestation or less with an incomplete abortion were eligible to participate. They were randomly assigned to receive either the standard treatment of care (manual vacuum aspiration for uterine evacuation with psychological support but no paracervical block) or manual vacuum aspiration treatment with psychological support and paracervical block using 1.0% lidocaine. Patients with active infections, severe illnesses, psychiatric disorders, or allergies to lidocaine were excluded. Intraoperative pain as reported by the women and as documented by an external observer was measured.
                Although the paracervical block technique used showed a slight reduction in severe pain, there were no clinically or statistically significant differences in intraoperative pain between the 2 groups (relative risk 0.73; 95% confidence interval 0.43, 1.23) with 50% of all patients registering 7 or higher score on a visual analog pain scale of 0-10. However, statistically significant differences were found in each group when comparing the level of preoperative and intraoperative pain described by the patient (P <.001). The manual vacuum aspiration technique and the paracervical block were not accompanied by complications.
                The paracervical block technique used in this study along with psychological support was comparable with pain control using psychological support alone; neither pain management regimen provided sufficient pain control. It is recommended that randomized comparative studies be designed to determine the effectiveness of other paracervical block techniques and the efficacy of the use of analgesics in patients suffering from incomplete abortion treated with manual vacuum aspiration. To determine whether selective decontamination locally in the subglottic area (SDSA) reduces tracheal colonization and prevents ventilator-associated pneumonia (VAP) in patients with multiple trauma.
                A prospective randomized, controlled, clinical study in a 14-bed general intensive care unit of a university hospital.
                79 consecutive multiple trauma patients admitted to the ICU who were expected to be mechanically ventilated for more than 5 days; 61 patients completed the protocol.
                Patients were randomly assigned to receive SDSA using a continuous infusion of a suspension containing three nonabsorbable antibiotics (polymyxin, tombramycin, and amphotericin B; n=30) or placebo ( n=31).
                The incidence of bronchial and gastric colonization and the number of cases of VAP were recorded. Gastric fluid and tracheal secretion cultures were obtained soon after intubation and thereafter every 4 days. Etiological diagnosis of VAP was based on samples taken by a specific protected double catheter set.
                VAP developed in 5 of 30 (16.6%) patients receiving SDSA and 16 of 31 (51.6%) patients receiving placebo. Negative bronchial secretion cultures were found in 14 of 30 (46.6%) patients in the SDSA group and in only 3 of 31 (9.6%) patients in the control group. No patient with negative bronchial secretion culture developed VAP. No significant differences in outcome were found.
                The SDSA is an effective and safe type of chemoprophylaxis against tracheal colonization and can significantly reduce the incidence of VAP in mechanically ventilated patients with multiple trauma.
For transcervical CVS, although there is some evidence to support the use of small forceps instead of cannulae, the evidence is not strong enough to support change in practice for clinicians who have become familiar with a particular technique. For transabdominal CVS, based on current evidence, there is no difference in clinically important outcomes with the use of a continuous compared with a discontinuous negative pressure needle aspiration system.