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Pectus Excavatum clinical trials

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NCT ID: NCT02174796 Completed - Pectus Excavatum Clinical Trials

Hemodynamic Repercussions of the Correction (Surgical and Non Surgical) of Pectus Excavatum-type Thoracic Deformities

PECTUS
Start date: May 5, 2014
Phase: N/A
Study type: Interventional

this non-randomized prospective study of 2 longitudinal cohorts (surgical treatment group or orthopedic treatment group), will evaluate the hemodynamic repercussions of the correction (surgical and non surgical) of pectus excavatum-type thoracic deformities by measuring the cardiac output difference before and after intervention, measured by transthoracic impedancemetry, during an exercise stress test

NCT ID: NCT02169297 Completed - Pain, Postoperative Clinical Trials

Sub-Paraspinal Block in Nuss Patients. A Pilot Project

Start date: November 2011
Phase: Phase 4
Study type: Interventional

The purpose of this pilot study was to evaluate effectiveness of a novel regional anesthesia technique developed at the investigators institution, as part of a quality improvement initiative, to assist with multilevel thoracic pain control in post-Nuss procedure patients. The investigators hypothesized that the local anesthetic infusion via bilateral multiperforated soaker catheters placed at extrathoracic sub-paraspinal muscle location under ultrasound guidance would significantly improve pain control, as reflected by the decrease in pain intensity score, reduction in opiate requirement and improvement infunctional rehabilitation measure scores in patients who underwent the Nuss procedure for pectus excavatum repair. However, the goal of this pilot study was not to detect a statistically significant difference in the primary outcomes between control and treatment groups (as the number of study subjects was chosen out of necessity of what could be completed within a specified time period), but to estimate the parameters which allows appropriate power and sample size calculations for a future multi-institutional study.

NCT ID: NCT02163265 Completed - Pectus Excavatum Clinical Trials

Impact of Surgical Treatments of Thoracic Deformation on Cardiopulmonary Functions

Start date: July 2014
Phase: N/A
Study type: Interventional

Pectus excavatum or carinatum are the most common congenital deformations of the ventral thoracic wall. Several different surgical methods with different techniques to correct these deformations have been described. Some clinicians recommend a correction of the deformation to improve the cardiopulmonary efficiency. Other think that the correction has a more an aesthetic than a physiological benefit. The aim of our prospective study is to evaluate whether patients with PE or PC are suffering preoperatively from a cardiopulmonary limitation at rest and under physical stress and if there is a change of cardiopulmonary function after the surgical correction.

NCT ID: NCT02056301 Terminated - Pectus Excavatum Clinical Trials

A Comparison Trial Between PCA and Epidural Analgesia for Pectus Excavatum Repair

Start date: August 2012
Phase: Phase 4
Study type: Interventional

The aim of this study is to compare the efficacy of epidural and IV analgesia in controlling pain in patients undergoing Nuss repair of pectus excavatum. The primary end point will be the mean pain score during postoperative days 0-4.

NCT ID: NCT02009267 Completed - Pectus Excavatum Clinical Trials

Nuss Procedure: Clinical Options in Pediatric Pain Management?

Start date: November 2013
Phase: N/A
Study type: Observational

A retrospective chart review study analyzing the benefits of patient controlled analgesia, thoracic epidural analgesia, and paravertebral nerve block catheters in patients having surgical repair of pectus excavatum using the Nuss procedure.

NCT ID: NCT01863498 Terminated - Pectus Excavatum Clinical Trials

Prospective Trial: Pain Management After Pectus Excavatum Repair, Epidural Versus PCA

PectusEpiPCA
Start date: May 2013
Phase: N/A
Study type: Interventional

Pectus excavatum, the most common chest wall deformity, occurs in roughly one in 1000 children. Operative repair of the anterior thoracic concavity has transitioned to the minimally invasive approach with substernal bar placement through small axillary incisions (Nuss procedure and multiple modifications). These procedures were quickly incorporated by high volume centers around the world including our own. The operation is certainly quicker and associated with less blood loss than the open operation, but as opposed to most minimally invasive versions of an operation, patients do not leave the hospital sooner after bar placement and experience more post-operative pain. Pain during the post-operative hospital stay is the dominant management issue after bar placement. The sparse literature on the topic has suggested that a thoracic epidural is the most effective means for attenuating the pain during the first few post-operative days. Therefore, most centers approach all patients undergoing a pectus deformity repair with an attempt at epidural placement under the assumption that this provides the most effective strategy for pain control. However, the investigators conducted a retrospective evaluation to examine the validity of this assumption and to investigate whether there is a role for a prospective study to determine the optimum post-operative pain management of these patients. The results demonstrate there was a decreased length of stay in the patients not treated with an epidural (PCA), despite no disadvantage in pain control. Further, 30% in whom an epidural was attempted, catheter placement failed. This data certainly challenges the assumption that an epidural is the optimum management for these patients, and convincingly answers the question as to whether there is a role for a prospective randomized trial.

NCT ID: NCT01816477 Completed - Pectus Excavatum Clinical Trials

Post Operative Pain Control Using Ropivacaine and the ON-Q System in the Adult Pectus Excavatum Patient After Minimally Invasive Repair

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

Pectus excavatum (PE) is a common chest wall deformity where the sternum is displaced posteriorly. In severe cases, surgery is performed to correct the defect (1). In recent years, minimally invasive surgery with the placement of stainless steel support bars has been increasingly performed in patients over the age of 17 years (1-9). Because of the decreased malleability and tremendous pressure required to hold the chest wall in the corrected position, post-operative pain control has been a significant problem in this patient population (2,6,9-12). Thoracic epidurals are commonly employed however mean hospitalizations of up to 7 days have been required before adequate pain control on oral analgesics is obtained (3-5, 13) and patients are suitable for discharge. It is hypothesized that using the ONQ system (I-Flow Corporation, Lake Forest CA) with bilateral intercostal catheter infusion would provide adequate post operative pain control with a significantly shorter hospital length-of-stay than thoracic epidural. Total use of narcotics for 1 week following surgery would also be less with the ONQ system versus epidural.

NCT ID: NCT01816373 Completed - Pectus Excavatum Clinical Trials

Non-invasive Negative Pressure Treatment for Pectus Excavatum

Start date: March 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether the non-invasive negative pressure treatment with the use of the device Vacuum Bellfor is effective for the pectus excavatum treatment

NCT ID: NCT01486953 Recruiting - Pectus Excavatum Clinical Trials

Pulmonary Mechanics During Minimally Invasive Repair of Pectus Excavatum

Start date: November 2011
Phase: Phase 4
Study type: Interventional

The aim of the current study was to compare the effects of sevoflurane and desflurane on respiratory mechanics in patients undergoing repair of pectus excavatum.

NCT ID: NCT01327274 Completed - Pectus Excavatum Clinical Trials

Multicenter Trial of Magnetic Mini-Mover for Pectus Excavatum

3MP
Start date: December 2011
Phase: N/A
Study type: Interventional

This study is a Phase 3, multicenter, non-randomized study to evaluate the safety and efficacy of the next-generation outpatient Magnetic Mini-Mover Procedure (3MP) in 15 patients aged 8-14 years for the correction of pectus excavatum ('sunken chest'). 3MP for pectus excavatum uses a magnetically coupled implant to pull the sternum forward and gradually remodel the deformed costal cartilage. The Funding Source for this trial is the FDA Office of Orphan Products Development (Grant #R01 FD003341).