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Evaluation of Diaphragmatic Function After Bi-pulmonary Transplantation (DIATRIB)
A current complication after lung transplantation is diaphragmatic dysfunction. These dysfunction result to several factors: duration of mechanical ventilation, chest tube, atelectasis, denutrition, phrenic nerve injury during surgical dissection… Only monocentric and retrospective studies collected diaphragmatic paralysis after lung transplant are published. The incidence of diaphragmatic paralysis in post-operative lung transplantation varies from 3.2% to 16.8%.
The main hypothesis of the study is to defined the incidence of diaphragmatic dysfunction in post-operative lung transplantation.
| Condition or disease |
|---|
| Lung Transplant, Diaphragmatic Function |
| Study Type : | Observational |
| Estimated Enrollment : | 60 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Evaluation of Diaphragmatic Function After Bi-pulmonary Transplantation |
| Actual Study Start Date : | January 3, 2019 |
| Estimated Primary Completion Date : | January 3, 2021 |
| Estimated Study Completion Date : | January 3, 2021 |
- incidence of diaphragmatic disorders (paralysis, severe and moderate dysfunction) in the post-operative period of bi-pulmonary transplantation [ Time Frame: 21 days ]incidence of diaphragmatic disorders (paralysis, severe and moderate dysfunction) in the post-operative period of bi-pulmonary transplantation
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Adults (≥ 18 years old)
- Admitted for intensive care that can be spontaneously ventilated after bi- pulmonary transplantation
Exclusion Criteria:
- Minor patient
- Ventilated patients less than 24 hours
- patients in controlled ventilation
| Contact: Thibaut GENTY, MD | 0140942260 | t.genty@hml.fr |
| France | |
| Centre Chirurgical Marie Lannelongue | Recruiting |
| Le Plessis-Robinson, France, 92350 | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 5, 2019 | ||||
| First Posted Date | June 6, 2019 | ||||
| Last Update Posted Date | June 6, 2019 | ||||
| Actual Study Start Date | January 3, 2019 | ||||
| Estimated Primary Completion Date | January 3, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
incidence of diaphragmatic disorders (paralysis, severe and moderate dysfunction) in the post-operative period of bi-pulmonary transplantation [ Time Frame: 21 days ] incidence of diaphragmatic disorders (paralysis, severe and moderate dysfunction) in the post-operative period of bi-pulmonary transplantation
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Evaluation of Diaphragmatic Function After Bi-pulmonary Transplantation | ||||
| Official Title | Evaluation of Diaphragmatic Function After Bi-pulmonary Transplantation | ||||
| Brief Summary |
A current complication after lung transplantation is diaphragmatic dysfunction. These dysfunction result to several factors: duration of mechanical ventilation, chest tube, atelectasis, denutrition, phrenic nerve injury during surgical dissection… Only monocentric and retrospective studies collected diaphragmatic paralysis after lung transplant are published. The incidence of diaphragmatic paralysis in post-operative lung transplantation varies from 3.2% to 16.8%. The main hypothesis of the study is to defined the incidence of diaphragmatic dysfunction in post-operative lung transplantation. |
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| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patient in immediate postoperative bi-pulmonary transplantation | ||||
| Condition | Lung Transplant, Diaphragmatic Function | ||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Unknown status | ||||
| Estimated Enrollment |
60 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | January 3, 2021 | ||||
| Estimated Primary Completion Date | January 3, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
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| Ages | 18 Years to 70 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03977597 | ||||
| Other Study ID Numbers | 2018-A02418-47 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Centre Chirurgical Marie Lannelongue | ||||
| Study Sponsor | Centre Chirurgical Marie Lannelongue | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Centre Chirurgical Marie Lannelongue | ||||
| Verification Date | May 2019 | ||||
