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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: 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: 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: 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.

NCT ID: NCT04418583 Recruiting - Pectus Excavatum Clinical Trials

Quantifying the Effect of the Crane Technique Through Three-dimensional Imaging

CRANE
Start date: May 13, 2020
Phase: N/A
Study type: Interventional

Pectus excavatum is the most common congenital abnormality of the thoracic wall and occurs in 1 in 400 newborns. The gold standard treatment is the Nuss bar Procedure. However, in very severe cases, pectus exacavatum involves little or no space between the heart and sternum. Because of the limited space, the Nuss procedure is more difficult to perform and there is an increased risk of complications such as injuries to the heart or large vessels. However, this increased risk can again be reduced by using the Crane technique. This technique increases the substernal space by sternal 'hoisting' via an external steel wire. Despite the fact that this technique is commonly used, it is not known what its quantitative effect is on the substernal space during the Nuss bar procedure. The subsequent aim of this study is to quantify the effect of the Crane technique during minimally invasive repair of pectus excavatum through three-dimensional scans acquired before and after application of the Crane technique.

NCT ID: NCT04211935 Recruiting - Pain, Postoperative Clinical Trials

Identification of Best Postoperative Analgesia Method Following a Minimally Invasive Repair of Pectus Excavatum

(MIRPE)
Start date: May 27, 2020
Phase: N/A
Study type: Interventional

Pectus excavatum is the most common chest wall deformity in children, accounting for 90% of all congenital chest wall deformities. It occurs in one to eight per 1000 live births. The severity of the pectus deformity may become more noticeable during pubertal growth spurs and repair is therefore usually performed in the teenage years. A common operative procedure to repair a pectus deformity is the minimally invasive repair of pectus excavatum (MIRPE). The MIRPE involves the substernal placement of a contoured metal bar secured to the lateral aspect of the ribs. This metal bar allows for correction of the concave deformity by applying constant outward pressure to the underside of the sternum. Although the cosmetic results are excellent, patients do report significant pain from the constant pressure exerted on the chest wall from the metal bar. Pain management approaches tend to differ on both the provider and institutional level. There is a lack of evidence regarding which postoperative analgesia method is best. To address this research gap, this proposal aims to conduct a randomized controlled trail using the three most commonly used methods; 1) patient controlled analgesia (PCA); 2) erector spinae blocks (ESB) with continuous infusion pumps; and 3) video-assisted intercostal nerve cryoablation (INC).

NCT ID: NCT04172142 Recruiting - Physical Disability Clinical Trials

Comparison of Physical and Psychosocial Characteristics of Pectus Excavatum and Carinatum Patients With Healthy Controls

Start date: November 7, 2019
Phase:
Study type: Observational

Chest wall deformities are the development of ribs, cartilage and sternum that form the chest wall together with isolated or abnormalities of the musculoskeletal system. Pectus excavatum and carinatum deformities are most common. It is reported that individuals with this problem have posture and physical impairments, difficulty in psychosocial relations and decreased quality of life.Therefore, in this study, the investigators aimed to evaluated the physical and psychosocial characteristics of patients with pectus excavatum and carinatum compared with healthy controls.

NCT ID: NCT04167865 Recruiting - Pectus Excavatum Clinical Trials

Effects of Exercise Therapy on Pectus Excavatum

Start date: September 12, 2019
Phase: N/A
Study type: Interventional

Pectus excavatum (PE); It is an anterior chest wall deformity, characterized by varying degrees of depression of the sternum and costal cartilage, usually occurring at birth or in the first year of life. In the treatment of non-severe PE; vacuum bell orthosis and physiotherapy (especially exercise) is recommended as an alternative to surgery. Although there is no literature or consensus about the role of physiotherapy, it is believed that it plays an important role in preventing or correcting deformities and creating a good cosmetic appearance. Therefore, in this study, the investigators aimed to investigate the effectiveness of exercise therapy in addition to vacuum bell therapy.