scholarly journals The Effects of Manual Lung Hyperinflation on Pulmonary Function after Weaning from Mechanical Ventilation among Patients with Abdominal Surgeries: Randomized Clinical Trial

2021 ◽  
Vol 10 (4) ◽  
pp. 216-222
Author(s):  
Mahboube Yazdani ◽  
Javad Malekzadeh ◽  
Alireza Sedaghat ◽  
Seyed Reza Mazlom ◽  
Aliyeh Pasandideh khajebeyk
Keyword(s):  
Clinical Trial ◽  
Mechanical Ventilation ◽  
Abdominal Surgery ◽  
Pulmonary Function ◽  
Randomized Clinical Trial ◽  
Arterial Oxygen ◽  
Control Group ◽  
Artificial Airway ◽  
Rapid Shallow Breathing Index ◽  
Significant Difference

Introduction: After abdominal surgery, the patients who are separated from mechanical ventilation and provided with oxygen therapy via a T-piece are at risk for respiratory complications. Therefore, they need additional respiratory support. This study aimed to evaluate the effects of manual hyperinflation (MHI) on pulmonary function after weaning. Methods: This randomized clinical trial included 40 patients who had undergone abdominal surgery and were receiving oxygen via a T-piece. Patients were selected from the intensive care units (ICU) of two hospitals in Mashhad, Iran. The subjects were randomly allocated to intervention (MHI) and control groups. Patients in the MHI group were provided with three 20-minute MHI rounds using the Mapleson C, while the control group received routine cares. Tidal volume (Vt), Rapid Shallow Breathing Index (RSBI), and the ratio of arterial oxygen partial pressure to fractional inspired oxygen (P/F ratio) were measured before the intervention, as well as 5 and 20 minutes after the intervention. Atelectasis prevalence was assessed before and 24 hours after the intervention. Data were analysed by SPSS software version 13. Results: At baseline, there were no significant differences between the groups regarding Vt, RSBI, P/F ratio, and atelectasis rate. No significant difference was also found between the groups regarding atelectasis rate 24 hours after the intervention. However, at both posttests, Vt, RSBI, and P/F ratio in the MHI group were significantly better than the control group. Conclusion: In patients with artificial airway and spontaneous breathing, MHI improves pulmonary function.

scholarly journals Convalescent Plasma for COVID-19: A multicenter, randomized clinical trial

2020 ◽  
Author(s):  
Cristina Avendano-Sola ◽  
Antonio Ramos-Martinez ◽  
Elena Munez-Rubio ◽  
Belen Ruiz-Antoran ◽  
Rosa Malo de Molina ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Mechanical Ventilation ◽  
Randomized Clinical Trial ◽  
Strong Dependence ◽  
Standard Of Care ◽  
Ordinal Scale ◽  
Control Group ◽  
Standard Of Care Treatment ◽  
And Control ◽  
To Receive

Background: Passive immunotherapy with convalescent plasma (CP) is a potential treatment for COVID-19 for which evidence from controlled clinical trials is lacking. Methods: We conducted a multi-center, randomized clinical trial in patients hospitalized for COVID-19. All patients received standard of care treatment, including off-label use of marketed medicines, and were randomized 1:1 to receive one dose (250-300 mL) of CP from donors with IgG anti-SARS-CoV-2. The primary endpoint was the proportion of patients in categories 5, 6 or 7 of the COVID-19 ordinal scale at day 15. Results: The trial was stopped after first interim analysis due to the fall in recruitment related to pandemic control. With 81 patients randomized, there were no patients progressing to mechanical ventilation or death among the 38 patients assigned to receive plasma (0%) versus 6 out of 43 patients (14%) progressing in control arm. Mortality rates were 0% vs 9.3% at days 15 and 29 for the active and control groups, respectively. No significant differences were found in secondary endpoints. At inclusion, patients had a median time of 8 days (IQR, 6-9) of symptoms and 49,4% of them were positive for anti-SARS-CoV-2 IgG antibodies. Conclusions: Convalescent plasma could be superior to standard of care in avoiding progression to mechanical ventilation or death in hospitalized patients with COVID-19. The strong dependence of results on a limited number of events in the control group prevents drawing firm conclusions about CP efficacy from this trial. (Funded by Instituto de Salud Carlos III; NCT04345523).

Compare the effect of aromatherapy using lavender and Damask rose essential oils on the level of anxiety and severity of pain following C-section: A double-blinded randomized clinical trial

2020 ◽  
Vol 17 (3) ◽  
Author(s):  
Ali Abbasijahromi ◽  
Hamed Hojati ◽  
Saeid Nikooei ◽  
Hossein Kargar Jahromi ◽  
Hamid Reza Dowlatkhah ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Essential Oil ◽  
Essential Oils ◽  
Randomized Clinical Trial ◽  
Control Group ◽  
Content Type ◽  
Gate Control Theory ◽  
Significant Difference ◽  
The Mean ◽  
Damask Rose

AbstractBackgroundAnxiety is the most common psychological reaction in women during labor. Similar to numerous other surgeries, postoperative pain is also reported following cesarean section (C-section). According to the (Gate) Control Theory, there is a relationship between pain and psychological problems such as anxiety. Accordingly, the present study aimed to compare the effect of aromatherapy using lavender and Damask rose essential oils on the level of anxiety and severity of pain following C-section.MethodsThis triple-group randomized clinical trial was performed on 90 mothers who visited Motahari Hospital of Jahrom, Iran, for C-section in 2017. The incidence and severity of pain and anxiety were measured and recorded for all three groups prior to intervention. The intervention groups underwent aromatherapy with lavender and Damask rose essential oils. Patients were asked to inhale cotton balls, separately stained with three drops of each essential oil at a distance of 10 cm for 30 mins. The severity of pain and anxiety was measured using the visual analogue scale (VAS) and the Spielberger State-Trait Anxiety Inventory (STAI) 5 min after the specified process, respectively. The control group underwent aromatherapy in a similar fashion with normal saline. Finally, data were analyzed using descriptive statistical indices and ANOVA and Kruskal–Wallis tests in SPSS 21.ResultsThere was no significant difference between the three groups in the mean severity of pain and anxiety before the intervention (p>0.05). The mean severity of pain and overt anxiety in the lavender and Damask rose aromatherapy groups was significantly different than the control group after the intervention (p<0.001). In addition, no significant difference was observed between the overt and overall anxiety levels of the two intervention groups after the intervention (p>0.05).ConclusionsThe findings suggested that inhalation aromatherapy can reduce the severity of overt anxiety and pain after C-section, with Damask rose essential oil showing a larger effect than lavender.

scholarly journals Impact of Mouthwashes on Antibacterial Activity of Subjects with Fixed Orthodontic Appliances: A Randomized Clinical Trial

2017 ◽  
Vol 18 (12) ◽  
pp. 1112-1116
Author(s):  
A Nishad ◽  
NS Sreesan ◽  
Joseph Joy ◽  
Lakshmi Lakshmanan ◽  
Joyce Thomas ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Antibacterial Activity ◽  
Randomized Clinical Trial ◽  
Control Group ◽  
Orthodontic Appliances ◽  
Group I ◽  
Fixed Orthodontic Appliances ◽  
Significant Difference ◽  
The Impact ◽  
Experimental Group

ABSTRACT Aim The study aimed to assess the impact of mouthwashes on antibacterial activity of individuals with fixed orthodontic appliances. Materials and methods A total of 60 individuals were considered in the study. Sixty (20 each group) nonextraction class I individuals were randomly divided into experimental and control groups. Group I: Experimental group [chlorhexidine (CHX) mouthwash], group II: Experimental group (neem mouthwash), group III: Control group (distilled water). All the clinical examinations were done at baseline and 30th day respectively, after the start of orthodontic treatment. The mean differences between the different experimental groups were calculated using one-way analysis of variance (ANOVA) test. Results There was no statistical significance at baseline mean plaque index (PI), gingival index (GI) scores, and Streptococcus mutans (SM) colony count between groups. The PI and GI scores among CHX and neem mouthwash groups (p = 0.002, p = 0.032 respectively) were significantly reduced after intervention and also the SM colonies count was reduced in CHX and neem mouthwash groups and there was significant difference between the groups. Conclusion As both mouthwashes showed significant effectiveness on antibacterial activity in individuals with fixed orthodontic appliances, neem mouthwash can be used as an alternative to CHX. Clinical significance It is better to have a sound knowledge regarding the use of mouthwash in long term as fixed orthodontics are associated with accumulation of SM, enamel demineralization, and an increased number of carious lesions, predominantly in sites adjacent to bracket. How to cite this article Nishad A, Sreesan NS, Joy J, Lakshmanan L, Thomas J, Anjali VA. Impact of Mouthwashes on Antibacterial Activity of Subjects with Fixed Orthodontic Appliances: A Randomized Clinical Trial. J Contemp Dent Pract 2017;18(12):1112-1116.

Effect of Low-Pressure Drainage Suction on Pharyngocutaneous Fistula After Total Laryngectomy

2020 ◽  
Vol 130 (1) ◽  
pp. 32-37
Author(s):  
Mojtaba Maleki Delarestaghi ◽  
Aslan Ahmadi ◽  
Fatemeh Dehghani Firouzabadi ◽  
Maryam Roomiani ◽  
Mohammad Dehghani Firouzabadi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Total Laryngectomy ◽  
Recovery Time ◽  
Low Pressure ◽  
Control Group ◽  
Pharyngocutaneous Fistula ◽  
Significant Difference ◽  
Drain Group ◽  
And Control

Objective: Pharyngocutaneous fistula (PCF) is one of the most severe multifactorial complications following laryngectomy. The current study aimed at determining the effect of a low-pressure vacuum drain on the incidence of PCF after total laryngectomy. Methods: The current randomized clinical trial was conducted on 35 patients undergoing total laryngectomy in Hazrat Rasoul Akram and Firoozgar hospitals in Tehran, Iran. The subjects were divided into the vacuum drain (n = 15) and control (without vacuum drain) (n = 20) groups. The incidence of PCF and the recovery time were recorded. Results: The rate of PCF formation from the stoma and wound edges was significantly lower in the low-pressure vacuum drain group than in the control group (6.7% vs 40%) ( P < .05). There was no significant difference between the groups in time to recovery from PCF. Conclusion: The low-pressure vacuum drain method is effective in reducing the incidence of PCF after total laryngectomy.

Comparison of Intra and Post-operative Sedation efficacy of Dexmedetomidine-Midazolam and Dexmedetomidine-Propofol for Major Abdominal Surgery

2021 ◽  
Vol 22 ◽  
Author(s):  
Yuanyuan Gao ◽  
Fei Yan
Keyword(s):  
Clinical Trial ◽  
Abdominal Surgery ◽  
Oxygen Saturation ◽  
General Anesthesia ◽  
Arterial Oxygen Saturation ◽  
Carbon Dioxide Tension ◽  
Major Abdominal Surgery ◽  
Arterial Oxygen ◽  
Anesthesia Induction ◽  
Significant Difference

Background: The effectiveness and side effects of dexmedetomidine (DEX) in combination with midazolam and propofol have not been comparatively studied in a single clinical trial as sedative agents to general anesthesia before. Objective: The objective of this study is to compare intra and post-operative sedation between DEX-Midazolam and DEX-Propofol in patients who underwent major abdominal surgery on the duration of general anesthesia, hemodynamic and sedation effect. Method: This prospective, randomized, double-blinded clinical trial included 50 patients who were 20 to 60 years of age and admitted for major abdominal surgery. The patients were randomly assigned by a computer-generated random numbers table to sedation with DEX plus midazolam (DM group) (n=25) or DEX plus propofol (DP group) (n=25). In the DM group, patients received a bolus dose of 0.1 mg/kg of midazolam and immediately initiated the intravenous (i.v.) infusion of DEX 1 µg/kg over a 10 min and 0.5 µg/kg/hr by continuous i.v. infusion within operation period. In the DP group, patients received pre-anesthetic i.v. DEX 1 µg/kg over 15 min before anesthesia induction and 0.2-1 µg/kg/hr by continuous i.v. infusion during the operative period. After preoxygenation for at least 2 min, during the surgery, patients received propofol infusion dose of 250 μg/kg/min for 15 min then a basal infusion dose of 50 μg/kg/min. The bispectral index (BIS) value, as well as mean arterial pressure (MAP), heart rate (HR), respiratory rate (RR), oxygen saturation (SaO2), percutaneous arterial oxygen saturation (SpO2) and end-tidal carbon dioxide tension (ETCO2) were recorded before anesthesia (T0), during anesthesia (at 15-min intervals throughout the surgical procedure), by a blinded observer. Evidence of apnea, hypotension, hypertension and hypoxemia were recorded during surgery. Results: The hemodynamic changes, including HR, MAP, BIS, VT, SaO2, and RR had a downward tendency with time, but no significant difference was observed between the groups (P>0.05). However, the two groups showed no significant differences in ETCO2 and SPO2 values in any of the assessed interval (P>0.05). In this study, the two groups showed no significant differences in the incidence of nausea, vomiting, coughing, apnea, hypotension, hypertension, bradycardia and hypoxemia (P>0.05). Respiratory depression and Conclusion: Our study showed no significant differences between the groups in hemodynamic and respiratory changes in each of the time intervals. There were also no significant differences between the two groups in the incidence of complication intra and post-operative. Further investigations are required to specify the optimum doses of using drugs which provide safety in cardiovascular and respiratory system without adverse disturbance during surgery.

scholarly journals Functional and Respiratory Capacity of Patients with Chronic Kidney Disease Undergoing Cycle Ergometer Training during Hemodialysis Sessions: A Randomized Clinical Trial

2019 ◽  
Vol 2019 ◽  
pp. 1-7 ◽  
Author(s):  
Antonio de Olival Fernandes ◽  
Yvoty Alves dos Santos Sens ◽  
Vivian Bertoni Xavier ◽  
Luiz Antonio Miorin ◽  
Vera Lúcia dos Santos Alves
Keyword(s):  
Clinical Trial ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Randomized Clinical Trial ◽  
Functional Capacity ◽  
Respiratory Function ◽  
Cycle Ergometer ◽  
Forced Expiratory Volume ◽  
Control Group ◽  
Significant Difference

Purpose. Exercise is recommended for patients undergoing hemodialysis, to reduce the decrease in functional capacity secondary to the progression of chronic kidney disease. A cycle ergometer can be easily added to an exercise routine during hemodialysis sessions. The purpose of this article was to assess the results of a training protocol with the cycle ergometer during hemodialysis sessions on the respiratory function and functional capacity of patients with chronic kidney disease on hemodialysis. Method. In this randomized clinical trial (NCT no. 02834026), 39 patients undergoing hemodialysis were randomly allocated into two groups: the treatment group (TG, n = 20), who underwent a cycle ergometer protocol training, and the control group (GC, n = 19), not trained. The TG attended 24 training sessions, three times a week, during the intradialytic period. Training intensity was aimed at keeping the heart rate between 50 and 70% of its maximum. All participants were evaluated before and after the eight consecutive weeks of follow-up and had biochemicals data, anthropometric, functional, and respiratory outcomes evaluated. Results. A significant difference was observed between groups in forced vital capacity, forced expiratory volume in the first second, peak expiratory flow, maximal inspiratory and expiratory pressure, and Borg score and distance covered in the six-minute walk test. Improvement was also observed in biochemical and Kt/V test results for the TG. Conclusion. The systematic training regimen with a cycle ergometer resulted in benefits in the respiratory function and functional capacity in patients with chronic kidney disease undergoing hemodialysis.

scholarly journals Investigating the Effects of picture book on Reducing Distress Caused by Intravenous Catheterization among School-aged Children (randomized clinical trial)

2020 ◽  
Author(s):  
Masoumeh Kanikzadeh ◽  
Rahim Tahmasebi ◽  
farideh bahreini ◽  
faezeh jahanpour
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Picture Book ◽  
Infusion Therapy ◽  
Control Group ◽  
School Aged Children ◽  
Distress Score ◽  
Significant Difference ◽  
Intravenous Catheterization ◽  
Catheterization Procedure

Abstract Background: Hospitalized pediatric patients experience pain, fear, and distress during intravenous catheterization. This study investigates the effects of a picture book on reducing distress caused by intravenous (IV) catheterization among school-aged children.Methods: seventy four Pediatric emergency room patients age 6-12 years old requiring Iv Infusion were enrolled in this randomized clinical trial. The intervention, providing a description of the IV catheterization procedure using a picture book, was compared to the same description of the procedure without a picture book (standard of care). Subject distress was measured using the Observation Scale of Behavior Distress Revised (OSBD_R) which assigns a score to eight observable behaviors. Before, during, and after the procedure at 15-second intervals (measured using a timer), a trained observer assigned an OSBD_R score of distress. A total score of 22 is considered maximum distress. The primary endpoint for the study was OBSD_R score difference in Phase 3 (Performing catheterization procedure, attaching and infusion therapy). Chi-square, Mann-Whitney and Wilcoxon tests were used for data analysis. Results: The mean distress score in third phases for the intervention group (0.667 ± 0.610) was significantly less than that of the control group (3.218 ± 1.799). A significant difference in distress score was observed before and after the intervention (p< 0.001).Conclusions: Children’s distress due to IV catheterization can be reduced with a simple, nonpharmacological picture book intervention. The children’s orientation on the IV catheterization plays a significant role in controlling and reducing their distress during and after the intervention. We suggested using the picture book to reduce the children distress before Intravenous Catheterization.

scholarly journals Comparison of Intraoperative Infusion of Remifentanil versus Fentanyl on Pain Management in Patients Undergoing Spine Surgery: A Double Blinded Randomized Clinical Trial

2021 ◽  
Vol 11 (4) ◽  
Author(s):  
Reza Shariat Moharari ◽  
Shervin Shahinpour ◽  
Negin Saeedi ◽  
Elaheh Sahraei ◽  
Atabak Najafi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Postoperative Pain ◽  
Randomized Clinical Trial ◽  
Spine Surgery ◽  
Intervention Group ◽  
Morphine Consumption ◽  
Control Group ◽  
Scoliosis Surgery ◽  
Canal Stenosis ◽  
Significant Difference

Background: Remifentanil is an ultra-short-acting opioid which facilitates hemodynamic management. However, there are concerns about postoperative Remifentanil hyperalgesia because of its potent fast onset and offset. Objectives: The aim of this study was to determine visual analog scale (VAS), postoperative pain, and morphine used in two groups after spine surgery. Methods: In this randomized clinical trial study, 60 patients aged 18 - 60 years old, according to the American Society of Anesthesiology (ASA) I - II, who underwent spinal canal stenosis or scoliosis surgery, were divided into two groups. In the control group, patients received 0.07 - 0.1 µg/kg/h intraoperative Fentanyl infusion, and in the intervention group 0.1 - 0.2 µg/kg/min remifentanil was infused during the surgery. Both groups received 15 mg/kg intravenous Acetaminophen 20 minutes before the end of the surgery. Postoperative pain score and morphine consumption were measured 6, 12, 24, and 48 hours after discharge from the post-anesthesia care unit (PACU). Results: During the first 12 hours, VAS and morphine consumption were significantly higher in remifentanil group (P < 0.001). However, no significant difference was found between the two groups in morphine consumption 12 - 48 hours after surgery. Conclusions: These findings suggest that Remifentanil infusion during surgery may increase postoperative pain. Also, VAS and morphine consumption were higher during the first 12 hours.

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