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Medical Device Discomfort clinical trials

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NCT ID: NCT02770638 Completed - Pain Clinical Trials

Tissue Interface Pressures in Athlete Medical Extraction

Start date: April 2016
Phase: N/A
Study type: Interventional

This study aims to establish clinical evidence for the use of scoop stretchers in the sports setting for spinal immobilisation and transport compared to the traditionally used long back boards through measuring tissue interface pressures over forty five minutes. All participants will be placed on both the scoop stretcher and the long back board for forty five minutes each, with at least 45 minutes between the two tests. A special mat that measures the pressure of the body against the board will be used to determine the pressure forces at certain points of the body touching the board (in mmHg). The participants will also be asked every five minutes during the experiment to rate the comfort of the device. Pressure measures from each participant on each board will be collated and assessed along with each participant's reported pain scores and comfort rating. The measurements from the tissue pressures will be analysed in real-time from the software connected to the pressure-mat and therefore show if pressures increase over time. A comparison between boards will be made.

NCT ID: NCT01829399 Completed - Clinical trials for Medical Device Discomfort

Control of Tourniquet Pain With an Axillary Ring of Subcutaneous Local Anesthetic

Start date: April 2013
Phase: Phase 4
Study type: Interventional

Purpose: Even with excellent regional anesthesia of the upper extremity, tourniquet (Tq) pain from an upper arm Tq can limit the ability to use regional anesthesia as the primary anesthetic for surgical procedures on the upper extremity. The aim of this study is to determine whether a subcutaneous ring of local anesthetic on the inner aspect of the upper arm just distal to axillary crease will significantly diminish Tq pain. If it does, peripheral nerve blocks distal to the Tq (i.e., nerve blocks at the elbow) could be used as the primary anesthetic for surgery of the hand and forearm. These distal peripheral nerve blocks have fewer complications than brachial plexus blocks performed at higher levels, and, postoperatively, the patient has better control of his or her arm when distal nerve blocks are used. Procedures (methods): This is a prospective, cross-over study to examine the effectiveness of an upper arm Subcutaneous ring of local anesthetic alone in relieving Tq pain. This Subcutaneous ring of local anesthetic is often referred to as "Intercostobrachial nerve block" or "Subcutaneous ring anesthesia (SRA)." Twenty volunteers will be randomized into four groups of 5 participants each. During the initial experiment, the first group will be given SRA with 10-15 mL of 0.25% Bupivacaine with Epinephrine 1:200,000 on their dominant arm, the second group will be given SRA with 10-15 mL of 0.25% Bupivacaine with Epinephrine 1:200,000 on their non-dominant arm, the third group will be given "sham" SRA with saline on their dominant arm, and the fourth group will be given "sham" SRA with saline on their non-dominant arm. 15 minutes after SRA, a Tq will be applied to the arm with the subcutaneous injection and it will be inflated to 100 mm Hg above the subject's baseline systolic blood pressure. We will monitor heart rate, blood pressure (opposite arm) and pain (0 to 10 VAS) every 5 minutes. Each Tq will be released when the subject requests deflation or when 1 hour of Tq time has elapsed, whichever occurs first. The subject's discomfort level (VAS) just prior to deflation will be recorded. Since Tq pressure alone can inhibit nerve function, we will monitor motor and sensory function distal to the Tq every 10 minutes during Tq inflation and for 30 minutes after Tq deflation. One to two weeks after this initial study, the same 20 subjects will receive SRA on the same arm and the same parameters will be measured. The 10 subjects who received 0.25% Bupivacaine the first time will receive Normal Saline, and the 10 subjects who received Normal Saline the first time will receive 0.25% Bupivacaine. In this way, each subject will act as his or her own control.

NCT ID: NCT01526226 Completed - Clinical trials for Respiratory Distress Syndrome, Newborn

Patient Comfort During High Flow Nasal Cannula Versus Nasal Continuous Airway Pressure (CPAP)

Start date: February 2012
Phase: N/A
Study type: Interventional

Preterm children are at increased risk for developing lung disease due to immature lungs. Non-invasive ventilation (NIV) support is increasingly used as treatment. Nasal continuous positive airway pressure (nCPAP) is the most common NIV-mode. Recently, high flow nasal cannulas (HFNC) have become an alternative NIV-mode. Both nCPAP and HFNC provide increased pressure in the airways aiming to keep the lungs open. With nCPAP it is common to use short binasal prongs that fill the nostrils completely and are pressed tightly over the nose. With HFNC oxygen/air is administered via two small, thin cannulas located just inside the nostrils, but the nostrils are not blocked. The aim of this study is to compare patient comfort in premature infants treated with nCPAP and HFNC. The investigators hypothesis is that HFNC increases patient comfort. The study is a randomized cross over study (2 x 24 hours). Children eligible for inclusion should be born before 34 weeks of gestation and have moderate respiratory distress, thus be "in need" of nCPAP. During the study period (48 hours) the investigators will consider how the child tolerates treatment with nCPAP versus HFNC. Primary outcome is patient comfort assessed with the EDIN-score (Neonatal pain and comfort score). Secondary outcomes are stress hormone response (cortisol in saliva), surrounding noise and parental satisfaction. The child's breathing pattern will be carefully monitored. The study involves no extra painful investigations. The investigators plan to recruit 20 patients.