A Review of Surgical Management of Congenital Pulmonary Airway Malformations (CPAM): A Decade of Experience
NCT ID: NCT04449614
Last Updated: 2020-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
72 participants
OBSERVATIONAL
2018-01-10
2020-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The surgical correction may involve 'open' surgery or 'key hole' surgery. There is, however, a variation in surgical and anaesthetic techniques and timing of this surgery and subsequent complications reported post-surgery.
The purpose of this investigation is to review anaesthetic and surgical case notes and the subsequent well-being of all children who underwent lung surgery to remove above lung lesions over the last 10 years (2008-2017) at a regional centre. The aim is to look at the current status of these children in relation to their health, growth and development evaluated via a 20-minute structured telephone interview with prior consent.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Respiratory and Psychological Impact of Elective Surgery of Congenital Lung Malformations
NCT06424392
An Audit of the Posterior Fossa Characterization in Open Spina Bifida Based on Tertiary Center Experience
NCT03544970
Sleep and Behavior in Children With Cleft Palate
NCT01046591
Articulation and Phonology in Children With Unilateral Cleft Lip and Palate
NCT00829101
Primary Palatoplasty in Pediatric Patients - A Retrospective Review of Surgical Outcomes
NCT01380171
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Historically, correction of CPAM was by open thoracotomy and surgical resection. This has evolved, however, and since 2008 more than 50 surgical corrections have been carried out thoracoscopically at King's College Hospital. The perioperative anaesthetic management of these children has also evolved, with the increasing use of selective lung ventilation.
The age range at surgery is variable, usually 1 - 14 years, and just over half being asymptomatic. Anaesthetic techniques are variable: for example, the deployment of selective lung ventilation techniques, the choice of anaesthetic agents and the types of invasive monitoring. Surgical duration is typically 3-4 hours. A degree of hypercarbia occurs in most cases during the procedure because of reduced minute ventilation to facilitate surgical access, and the absorption of carbon dioxide insufflated into the pleural space. Around 1/3rd receive blood transfusions. Perioperative complications include: respiratory problems causing hypoxia, requirement for re-intubation, conversion to open thoracotomy, bradycardia, surgical emphysema and sometimes the requirement for prolonged post-operative respiratory support including ventilation, CPAP and chest drain management, bronchopulmonary fistulae, and chylothorax and rarely seizures and cerebral infarction.
In general, post-operative care includes at least 24 hours critical care and another 6-7 days in hospital. The mainstay of early post-operative pain control is either with morphine using a nurse controlled intravenous analgesia system, or with epidural analgesia. These are supplemented with oral analgesic regimens. Children who were preoperatively symptomatic seem more likely to develop perioperative complications.
Objective The purpose of this investigation is to review all children who underwent CPAM surgery over the last 10 years at a single regional centre and carry out a descriptive evaluation of pre-operative factors, anaesthetic and surgical factors, peri- and post-operative morbidity, mortality and subsequent long term outcome.
Methods A retrospective review of all CPAM resections performed since 2008 at a single centre. The data will be retrieved from electronic and paper based medical records, anaesthetics records and operation notes. A prospective analysis of the post-operative course and events will be undertaken. A detailed evaluation of these children in relation to their health, growth and development will be carried out via a structured 20-minute telephone interview with prior consent.
Analysis Outcomes will be compared across preoperatively symptomatic and asymptomatic groups using Mann-Whitney/Wilcoxon test or Student t test for continuous data or the chi square for categorical data. All tests were 2-tailed, and P\< 0.05 was considered statistically significant.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Inclusion criteria: All consenting Infants and children who have had A Congenital Pulmonary Airway Malformation (CPAM) surgically removed by thoracoscopy over a 10 year period (2008-2017) in a regional centre.
Exclusion criteria: Non consenting participants
Thoracoscopic CPAM resection
Surgical removal of lung lesion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Thoracoscopic CPAM resection
Surgical removal of lung lesion
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
16 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
King's College London
OTHER
King's College Hospital NHS Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Chulananda Goonasekera
Role: PRINCIPAL_INVESTIGATOR
Consultant Anaesthetist
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kings College Hospital NHS Trust
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Subramanyam R, Ledbetter K, Fleck R, Mahmoud M. Images in Anesthesiology: Congenital Pulmonary Airway Malformation. Anesthesiology. 2017 Aug;127(2):382. doi: 10.1097/ALN.0000000000001602. No abstract available.
Cloutier MM, Schaeffer DA, Hight D. Congenital cystic adenomatoid malformation. Chest. 1993 Mar;103(3):761-4. doi: 10.1378/chest.103.3.761.
Sfakianaki AK, Copel JA. Congenital cystic lesions of the lung: congenital cystic adenomatoid malformation and bronchopulmonary sequestration. Rev Obstet Gynecol. 2012;5(2):85-93.
Mann S, Wilson RD, Bebbington MW, Adzick NS, Johnson MP. Antenatal diagnosis and management of congenital cystic adenomatoid malformation. Semin Fetal Neonatal Med. 2007 Dec;12(6):477-81. doi: 10.1016/j.siny.2007.06.009. Epub 2007 Oct 22.
David M, Lamas-Pinheiro R, Henriques-Coelho T. Prenatal and Postnatal Management of Congenital Pulmonary Airway Malformation. Neonatology. 2016;110(2):101-15. doi: 10.1159/000440894. Epub 2016 Apr 13.
Sueyoshi R, Koga H, Suzuki K, Miyano G, Okawada M, Doi T, Lane GJ, Yamataka A. Surgical intervention for congenital pulmonary airway malformation (CPAM) patients with preoperative pneumonia and abscess formation: "open versus thoracoscopic lobectomy". Pediatr Surg Int. 2016 Apr;32(4):347-51. doi: 10.1007/s00383-015-3848-z. Epub 2015 Dec 12.
CH'IN KY, TANG MY. Congenital adenomatoid malformation of one lobe of a lung with general anasarca. Arch Pathol (Chic). 1949 Sep;48(3):221-9. No abstract available.
Laberge JM, Flageole H, Pugash D, Khalife S, Blair G, Filiatrault D, Russo P, Lees G, Wilson RD. Outcome of the prenatally diagnosed congenital cystic adenomatoid lung malformation: a Canadian experience. Fetal Diagn Ther. 2001 May-Jun;16(3):178-86. doi: 10.1159/000053905.
Kapralik J, Wayne C, Chan E, Nasr A. Surgical versus conservative management of congenital pulmonary airway malformation in children: A systematic review and meta-analysis. J Pediatr Surg. 2016 Mar;51(3):508-12. doi: 10.1016/j.jpedsurg.2015.11.022. Epub 2015 Dec 9.
Khan H, Kurup M, Saikia S, Desai A, Mathew M, Sheikh A, Goonasekera CDA. Morbidity after thoracoscopic resection of congenital pulmonary airway malformations (CPAM): single center experience over a decade. Pediatr Surg Int. 2021 May;37(5):549-554. doi: 10.1007/s00383-020-04801-1. Epub 2021 Jan 3.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRAS 238420
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.