Gastrostomy tubes are medical devices used to provide nutrition directly to the stomach when oral intake is insufficient. Clinical trials involving gastrostomy tubes examine various aspects such as optimizing placement techniques, evaluating device m...

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Found 15 Actively Recruiting clinical trials

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Actively Recruiting

Obesity is a chronic and complex disease characterized by excessive body fat that can harm health. This research investigates the relationship between body mass index (BMI), fasting duration, and the risk of aspiration by measuring gastric residual volume using gastric ultrasonography in obese patients undergoing laparoscopic bariatric surgery. The study focuses on patients with BMI over 35 kg/m², as obesity increases the risk of complications like delayed gastric emptying and pulmonary aspiration during anesthesia. Before surgery, participants will receive gastric ultrasonography in two positions to measure stomach contents and calculate gastric residual volume, which helps assess aspiration risk. Patients will then undergo standard anesthesia and bariatric surgery with careful monitoring of anesthesia depth and vital signs. Postoperative care includes pain management and nausea evaluation. The study also collects detailed clinical data, including lab tests and medical history. Participants will be closely monitored throughout the surgery and recovery. Researchers will record aspiration events, surgical duration, and postoperative nausea severity at multiple time points. The primary focus is on correlating BMI with gastric residual volume and aspiration risk, while also examining fasting duration's effect. The total involvement includes preoperative assessment, surgery, and postoperative follow-up to evaluate safety and outcomes in this patient group.

Age: 18Years - 65YearsAll Genders
1 location
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Actively Recruiting

Researchers are evaluating the use of an ultrasound-guided external oblique intercostal fascial plane (EOI) block to reduce pain during and after laparoscopic gastrostomy surgery in children ages 3 to 18 years. This randomized controlled trial compares the effects of the EOI block using ropivacaine against a sham block using normal saline to understand its impact on heart rate changes and pain management during surgery. Participants will be randomly assigned to receive either a bilateral EOI block with 0.25% ropivacaine or a sham block with normal saline, both performed under ultrasound guidance. The study measures include the percent change in heart rate at the time of surgical incision as the primary outcome, along with secondary outcomes such as fentanyl use during surgery, various pain scores, analgesia nociception index values, and any analgesia-related side effects. During the study, children's pain levels will be monitored at multiple time points after surgery using standardized pain scales. Researchers will also track the use of pain medications up to 24 hours post-operation and monitor for any adverse effects related to analgesia. The trial is conducted under general anesthesia, and heart rate and blood pressure changes will be recorded around the time of surgery to evaluate the intervention's effectiveness.

Age: 3Years - 17YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are studying a new type of adjustable skin disk called the Constant Pressure Skin Disk (CPSD) for use with feeding tubes placed in the stomach or small intestine, such as gastrointestinal gastrostomy (GIG) or jejunostomy (GIJ) tubes. The study aims to find out if the CPSD supports proper healing and reduces complications compared to the usual external skin disks. This research is led by Mayo Clinic and involves outpatient adults who need these feeding tubes. During the feeding tube placement procedure, a gastroenterologist or interventional radiologist will replace the standard adjustable skin disk with the CPSD by sliding the original disk off and sliding the CPSD onto the tube. Participants will receive regular care for their tube placement along with the CPSD device. The study focuses on the durability of the CPSD over 180 days and monitors any adverse events during this period. Participants will be followed for six months after placement to assess how well the CPSD holds up and to track any complications. Researchers will evaluate device durability and record any side effects or problems related to the CPSD. The study involves regular assessments during this time to gather safety and performance data, helping to understand if the CPSD could be a better option for patients needing feeding tubes.

Age: 22Years +All GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are evaluating the accuracy and reliability of ultrasound Doppler for confirming the correct placement of gastric feeding tubes (GFTs) in intensive care unit (ICU) patients. The study compares ultrasound results to the standard method of chest X-ray (CXR) to see if ultrasound can safely and effectively determine GFT positioning. This research focuses on ICU patients who are intubated and require GFT placement or replacement. Patients will receive a gastric feeding tube, and ultrasound imaging will be performed at both the mid-esophagus and stomach levels using a handheld device. During ultrasound, 20 mL of air will be insufflated through the GFT or a suction catheter in the trachea to look for a specific "mosaic sign" that indicates correct placement in the stomach. These ultrasound images will be anonymized and reviewed by an expert intensivist, then compared to chest X-ray findings. Participants will undergo ultrasound and chest X-ray assessments after GFT placement or replacement. Data collected includes ultrasound images, patient details, ventilator settings, and chest X-ray results. Researchers will monitor safety by recording any adverse events. The main goal is to test how well ultrasound detects proper GFT position. The study is expected to last until August 2025, with ongoing data collection and monitoring during this time.

Age: 18Years +All Genders
1 location
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Actively Recruiting

Obese patients undergoing sedative gastroscopy often face increased risks of hypoxemia due to fat accumulation in the head and neck, increased soft tissue in the oropharynx, reduced lung compliance and volumes, and sometimes obstructive sleep apnea. This research aims to evaluate the safety and optimal flow rate of high-flow nasal cannula oxygen therapy (HFNC) at 30 L/min, 50 L/min, and 70 L/min in obese patients during painless gastroscopy to reduce hypoxia risk without causing discomfort. The study compares three intervention groups where patients receive HFNC oxygen therapy starting with pre-oxygenation at 30 L/min for one minute, then sedation is administered. Oxygen flow is maintained at 30 L/min in one group, increased to 50 L/min in another, and to 70 L/min in the last group after sedation begins. If hypoxemia occurs, behavioral interventions such as jaw lift, increased oxygen flow, mask ventilation, and intubation may be used sequentially to improve oxygenation. Participants will undergo assessments during the procedure focusing on the incidence of hypoxia and related complications such as respiratory depression, airway obstruction, adverse events, paradoxical responses, and airway interventions within six minutes before gastroscopy completion. The study involves monitoring oxygen levels and patient safety throughout the procedure to determine the best HFNC flow rate. The total participation duration corresponds with the gastroscopy procedure and monitoring period.

Age: 18Years +All GendersPhase Not Applicable
1 location
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Actively Recruiting

This trial is studying an interdisciplinary approach to help children under 3 years old with feeding tubes and tracheostomies transition to oral feeding. The study evaluates whether combining in-home clinical assessments with virtual therapies by a specialized team can improve feeding outcomes. The goal is to increase oral feeding and reduce dependence on feeding tubes while supporting caregivers' confidence and reducing their worry about feeding. Participants are randomly assigned to either an intervention group or a control group. The intervention group receives weekly virtual group mealtime sessions plus biweekly individualized virtual therapies from a team including occupational therapists, speech-language pathologists, registered dietitians, and a developmental behavioral pediatrician. The control group attends weekly virtual group mealtime sessions only. Both groups continue any existing standard care therapies. The study includes initial in-home assessments, ongoing virtual therapy sessions, and a final home visit after one year. Families will participate in enrollment via video conferencing, complete surveys, and take part in scheduled virtual therapy and group sessions over one year. Assessments of feeding, oral intake, caregiver confidence, and dietary history occur at baseline, 3, 6, 9 months, and at the final exit visit after 12 months. Researchers monitor changes in oral calorie intake, feeding frequency, and caregiver self-efficacy. Safety and progress are tracked through regular surveys and home visits during the study period.

Age: 0 - 3YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are evaluating the use of a nasopharyngeal airway (NPA) combined with nasal high-flow oxygen therapy (HFNC) during painless gastroscopy in patients with obesity. Gastroscopy is a common method to screen and diagnose digestive tract diseases but can cause discomfort and adverse reactions. Obese patients face a higher risk of hypoxia during sedation due to changes in airway anatomy and respiratory function, so this study aims to see if combining NPA with HFNC can reduce hypoxia incidents in this group. The study compares two approaches during painless gastroscopy for obese patients. One group receives high-flow nasal cannula oxygen at 30 L/min after sedation, while the other group receives the same oxygen flow plus the insertion of an NPA to keep the airway open. Both groups start with pre-oxygenation using pure oxygen at 30 L/min for one minute before sedation. The trial involves random assignment to these groups and single masking during the procedure. Participants will be monitored for hypoxia and other respiratory complications during and after the gastroscopy, with evaluations occurring 6 minutes post-procedure. Assessments include the incidence of hypoxia, subclinical respiratory depression, severe hypoxia, airway complications, adverse events, and airway interventions needed. The study also tracks patient comfort and safety. The total participation time includes the gastroscopy and immediate post-procedure monitoring, aiming to improve respiratory management in obese patients undergoing painless gastroscopy.

Age: 18Years +All GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are investigating the role of gut microbiota in anorexia nervosa (AN), a serious mental disorder mostly affecting women and characterized by severely restricted food intake and low body weight. This condition often leads to medical complications and psychiatric issues, with current treatments linked to gastrointestinal problems and high relapse rates. The study aims to better understand how gut microbes are affected by standard care treatment and explore the potential of prebiotics as a new approach to improve health and weight restoration in AN patients. The study includes female participants aged 16 to 50 years divided into two groups: those with AN and healthy controls with normal to mild overweight BMI ranges. The AN group will undergo a standard care treatment program involving psychotherapy and nutritional rehabilitation to normalize food intake and promote weight gain. Samples and data are collected at baseline before starting clinical treatment, and again at approximately 6 and 12 weeks during treatment. Healthy controls provide data at one time point only. Participants will have their fecal microbiota composition studied alongside assessments of mental health and gastrointestinal symptoms at multiple time points. Researchers will analyze associations between microbiota diversity, serum biomarkers, diet, and clinical symptoms. The study monitors changes during the treatment period to understand microbiota dynamics and their relation to mental and gastrointestinal health. The study is expected to continue until 2043, aiming to pave the way for personalized prebiotic treatments for AN.

Age: 16Years - 50YearsFEMALE
1 location
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Actively Recruiting

Researchers are studying the effects of oral glutamine supplementation on patients with gastric adenocarcinoma who undergo gastrectomy. The main goal is to assess how glutamine impacts sarcopenia, a condition involving muscle loss, in these patients. Secondary goals include evaluating changes in physical activity, weight loss, and nutritional status during recovery. This double-blind, randomized, placebo-controlled trial will enroll at least 80 patients scheduled for gastrectomy. Participants will be divided into two groups: one receiving 10 grams of glutamine plus 5 grams of maltodextrin daily for 28 days after surgery, and the other receiving 15 grams of maltodextrin as a placebo for the same period. Both groups will take the supplements orally or via enteral feeding as tolerated. Before surgery and 90 days after, CT scans will measure muscle area changes. Patients will wear smartwatches to track daily walking steps, and laboratory tests including serum albumin, pre-albumin, white blood cell, and lymphocyte counts will be conducted before surgery and 90 days postoperatively. The main outcome is the change in psoas muscle area 84 days after surgery. Participants' physical activity, weight, and nutritional markers will also be monitored throughout the study.

Age: 20Years +All GendersPhase Not Applicable
1 location
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Actively Recruiting

This research aims to evaluate abdominal pain and its predictive factors following the placement of a percutaneous radiologic gastrostomy (PRG). PRG is a method used primarily for enteral nutrition that offers advantages such as being done under local anesthesia and having higher success rates than percutaneous endoscopic gastrostomy (PEG). The study focuses on understanding the prevalence and severity of pain after PRG placement, which is a known complication often requiring pain treatment. Participants undergo PRG placement and then complete a numerical pain scale questionnaire ranging from 0 to 10. This observational, single-center study lasts 12 months and tracks abdominal pain from baseline until 7 days after the PRG procedure. The study also aims to identify factors that might predict the level of pain experienced after the placement. During the study, participants will be asked to report their abdominal pain daily for a week using the questionnaire. Researchers will evaluate the pain intensity and analyze predictive factors on the first day after PRG placement. The total participation involves monitoring the pain experience closely in the first week to better understand and manage this complication.

Age: 18Years +All Genders
1 location

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