NCT05131945Completed
GRAvity- Versus Wall Suction-drIven Large Volume Thoracentesis: a RAndomized Controlled Study (GRAWITAS Study)
Source: ClinicalTrials.gov · Last updated 19 Sept 2024
Brief summary (registry, in English)
The primary objective of this study is to compare gravity-driven versus wall suction-driven large volume therapeutic thoracentesis on the development of chest discomfort during the procedure. This study is a multicenter, single-blinded, randomized controlled trial designed to compare chest discomfort between gravity-driven and wall suction-driven therapeutic thoracentesis. Patients will be stratified by study centers, and randomly assigned to intervention and control arms; and will remain blinding to their group assignment during the procedure.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 79 (actual)
- First submitted
- 27 Oct 2021
- Start date
- 10 Dec 2018
- Primary completion date
- 10 Sept 2024
- Lead sponsor
- M.D. Anderson Cancer Center
- NCT number
- NCT05131945
What you commit to
- Study type: Interventional
- Participants enrolled: 79
- From 10 Dec 2018 to the primary completion date, 10 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Study subject has any disease or condition that interferes with safe completion of the study including:
- Coagulopathy, with criteria left at the discretion of the operator
- Hemodynamic instability with systolic blood pressure \<90 mmHg or heart rate \> 120 beats/min, unless deemed to be stable with these values by the attending physicians
Other
- Inability to provide informed consent
- Pleural effusion is smaller than expected on bedside pre-procedure ultrasound
- Referral is for diagnostic thoracentesis only
- Presence of more than minimal septations and/or loculations( more than 3) on bedside pre-procedure ultrasound
- Inability to sit for the procedure
- Pregnancy
Who the study is looking for
- Referral to pulmonary services for large-volume thoracentesis
- Presence of a symptomatic moderate or large free-flowing (non-septated) pleural effusion on the basis of:
- Chest radiograph: effusion filling ≥ 1/3 the hemithorax, OR
- CT-scan: maximum AP depth of the effusion ≥ 1/3 of the AP dimension on the axial image superior to the hemidiaphragm, including atelectatic lung completely surrounded by effusion, OR Ultrasound: effusion spanning at least three interspaces, with depth of 3 cm or greater in at least one intercostal space, while the patient sits upright.
- Age \>/= 18
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.