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Funnel Chest clinical trials

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NCT ID: NCT06110689 Recruiting - Pectus Excavatum Clinical Trials

Capturing Physiologic Autonomic Data From Clinically Indicated Magnetic Resonance Imaging Scans in Children

CMRI
Start date: October 3, 2023
Phase:
Study type: Observational

The Fontan Procedure is a palliative surgical procedure used in pediatric patients with one functional ventricle. The procedure, a series of stepwise operations that alter cardiorespiratory physiology, separate the systemic and pulmonary circulations to create Fontan physiology, where the systemic venous blood flows passively and without ventricular thrust into the pulmonary circulation. The hallmark of the Fontan circulation is a sustained, abnormally elevated central venous pressure combined with decreased cardiac output, especially during periods of increased demands. Results of several studies in Fontan patients have shown reduced parasympathetic and sympathetic activity compared to controls. In children with congenital heart disease, a differential diagnosis of autonomic dysfunction may be part of their pathophysiology, a compensatory mechanism, a consequence of surgical procedures or a combination of these. In children, measurement of ANS function is equally important. Children with single ventricle physiology (and other cardiac conditions) have routine surveillance and cardiac magnetic resonance (CMR) imaging to monitor for disease progression. While autonomic data is routinely collected and is available from these scans, these data are rarely, collected and analyzed; however, our group has shown feasibility. Therefore, autonomic data is usually unavailable in children. Despite the availability of agerelated normal values, the predictive power of autonomic activity is understudied in children and there are no published studies of quantification of autonomic data in this population.

NCT ID: NCT05844800 Completed - Pectus Excavatum Clinical Trials

The Effect of Surgical Repair of Chest on Postural Stability Among Patients With Pectus Excavatum

Start date: January 2011
Phase: N/A
Study type: Interventional

The goal of this study is to determine the effect of Nuss minimally-invasive repair technique of pectus excavatum (PE) on the postural stability in patients with PE. The main questions it aims to answer are: - How surgical chest wall repair will affect postural stability of PE patients? - What is the difference in postural stability between patients with PE and healthy controls? Participants will undergo the Nuss repair surgery and will be tested before and afterwards for their postural stability with the use of the posturography method. Researchers will compare PE male patients and healthy young men to see if PE posture defect affects postural stability.

NCT ID: NCT05831137 Recruiting - Funnel Chest Clinical Trials

Cryoanalgesia Aplication Time Optimization During Nuss Procedure

Start date: March 31, 2023
Phase: N/A
Study type: Interventional

This study compared standard therapy (multimodal analgesia with 2 minutes cryoanalgesia) versus a novel approach (multimodal analgesia with 1 minute cryoanalgesia) in subject undergoing minimal invasive modyfied Nuss procedure with thoracoscopy.

NCT ID: NCT05731973 Recruiting - Pectus Excavatum Clinical Trials

Intercostal Nerve Cryoablation Versus Epidural Analgesia for Nuss Repair of Pectus Excavatum

ICE
Start date: December 8, 2023
Phase: N/A
Study type: Interventional

Primary objective of the current study is to determine the impact of intercostal nerve cryoablation on postoperative length of hospital stay compared to standard pain management of young pectus excavatum patients (12-24 years) treated with the minimal invasive Nuss procedure. The study is designed as a single center, prospective, unblinded, randomized clinical trial.

NCT ID: NCT05634070 Recruiting - Pectus Excavatum Clinical Trials

Pectus Excavatum Camouflage (IT)

Start date: December 14, 2022
Phase: N/A
Study type: Interventional

The clinical study evaluates the use of a custom-made medical-grade polycaprolactone-PCL Pectus scaffold implantation with Autologous Fat Grafting for pectus excavatum camouflage (IT). The study aims to demonstrate the safety and clinical performance of the insertion of an absorbable "medical-grade polycaprolactone-PCL Pectus Scaffold" in the thorax region with Autologous Fat Grafting in the correction of congenital Pectus Excavatum unsuitable for conventional treatment with stable cardio-respiratory function. The PCL Pectus Scaffold-based design has the potential to induce sustained regeneration to fill large volume pectus excavatum defects, with the added benefit of being light weight and resorbable, thus not affecting the patients function capacity and reducing the risk of implant-related complications.

NCT ID: NCT05570097 Completed - Funnel Chest Clinical Trials

Cryoanalgesia to Prevent Acute and Chronic Pain Following Nuss Procedure

Start date: September 28, 2022
Phase: N/A
Study type: Interventional

This Study study compared standard therapy (multimodal and regional analgesia) versus a novel approach (Cryoanalgesia combined with bilateral erector spine plane block and multimodal analgesia) in subjects undergoing minimal invasive modyfied Nuss procedure (thoracoscopy).

NCT ID: NCT05451108 Recruiting - Pectus Excavatum Clinical Trials

Pectus Excavatum Camouflage

Start date: December 10, 2021
Phase: N/A
Study type: Interventional

The clinical study is testing a new treatment for pectus excavatum called "custom-made 3D printed scaffold-based soft tissue reconstruction". The new method uses a combination of the patients own adipocytes (fat cells) with a 3D printed scaffold (PCL Pectus Scaffold) to support soft tissue regeneration in the patient's chest using the body's natural healing processes. The implanted scaffold acts as a resorbable frame to support the growth of cells. The substance used for the scaffold is resorbable, it's similar to the substance used for sutures and stitches, and it's already Therapeutic Goods Administration (TGA) approved for bone reconstruction of the skull. The implanted scaffold degrades over time, leaving the tissue in its place.

NCT ID: NCT05443113 Completed - Genetic Disease Clinical Trials

Young Pectus Excavatum Patients and Genetic Defects

Start date: September 1, 2019
Phase:
Study type: Observational

In most pectus excavatum (PE) patients an underlying genetic defect is not found with molecular analysis, as a direct genetic link with PE has yet to be found and because potential underlying genetic disorders are quite rare. Only one-fifth of all PE cases are identified in the first decade of life and thus of congenital origin making younger PE patients a unique patient group. Therefore, the research question is; is early-onset pectus excavatum (PE) more likely to be part of a genetic defect than PE which became apparent during puberty or adolescence?

NCT ID: NCT05201820 Completed - Pectus Excavatum Clinical Trials

Cryoanalgesia for Pain Management After Pectus Excavatum Repair

COPPER
Start date: February 1, 2022
Phase: N/A
Study type: Interventional

Cryoanalgesia for pain management after pectus excavatum repair. COPPER study (CryoanalgesiafOr Pain management after Pectus Excavatum Repair): a randomized controlled trial. Determine if, in patients more than 12 years of age having cryoanalgesia for pectus excavatum repair analgesia improves the standard of care (epidural analgesia) in term of pain relief and return to normal life 2 weeks after surgery. Randomized active controlled, parallel group, single-centre, trial (category IIb medical device). 88 patients aged more than 12 years of age scheduled for pectus excavatum repair. After randomization, patients will receive intraoperative cryo-analgesia or standard of care (epidural-analgesia). PedsQLscale (23 items) two weeks after surgery. Patients will be followed for 6 months after surgery to determine time until return to normal life and occurrence of any complication related to the use of cryo-analgesia. Numeric Rating Scale (NRS), CALI9, YAPFAQ will be measured at fixed times to determine pain intensity and limitations due to pain. Risk factors for prolonged pain and time needed until achieving discharge criteria from hospital will be reported.

NCT ID: NCT05124626 Recruiting - Funnel Chest Clinical Trials

Evaluation of Chest Wall Motility After MIRPE

Start date: October 1, 2021
Phase: N/A
Study type: Interventional

Pectus excavatum (PE) is the most common congenital deformity of the chest wall and surgical treatment using the minimally invasive technique (MIRPE) is consolidating as the choice to perform PE correction. In this technique, a temporary metal bar is placed in a retrosternal position, pushing the sternum without the need for cartilage resection. Despite the advantages obtained, it is not free from complications, with the displacement of the bar being one of the main problems. Therefore, the aim of this study is to evaluate a new bridging device for the set of two metal bars to be used in the surgical treatment of PE, verifying the clinical and surgical complications and evaluating the change in lung volumes and thoracoabdominal kinematics using optoelectronic plethysmography , preoperatively and 180 days after MIRPE; and also evaluating diaphragmatic mobility via ultrasound examination to assess the craniocaudal displacement of the left branch of the vein preoperatively and 180 days later. There will be 20 participants, who after performing a computed tomography of the chest to obtain the Haller index, clinical and laboratory tests, electrocardiogram and echocardiogram. Participants will be randomized and divided into two groups: 10 control individuals (traditional MIRPE technique used in the Service) and 10 intervention individuals (with bridge fixators developed in partnership with Traumec Tecnologia e Implantes, Brazil). The effectiveness of the fixators will be evaluated by the degree of displacement of the bars, using a mathematical formula, using a lateral chest X-ray in the immediate postoperative period (d0) and another image from the end of the period analyzed (dX), 15, 30, 90 and 180 days after the surgical procedure; evaluation of postoperative pain through the numerical pain scale; use of validated questionnaires on quality of life (physical and mental health) using two instruments, SF-36 and PEEQ. All data obtained between the two groups will be submitted to descriptive and inferential statistics.