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NCT06157138 Clinical Trial

Observation of B-lines in Pulmonary Echography, During Open Abdominal Surgery

Lung Ultrasound Clinical Trial

— LUS-SURG  

Official title:
Incidence of B-Lines in Pulmonary Echography, in Patients Undergoing Open Abdominal Surgery.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06157138
Other study ID # 230209001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 26, 2023
Est. completion date December 2024

Study information
Verified date December 2023
Source Pontificia Universidad Catolica de Chile
Contact Augusto Rolle, MD
Phone 56+95504 3414
Email ajrolle@uc.cl
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

There is no a reliable marker of intraoperative fluid excess or overload. The use of lung ultrasound in other settings, such as emergency room and critical care patients, helps us to determine if a patient has a condition of augmented intrathoracic fluid, that could be related to several circumstances, such as fluid overload, but also to heart failure, in example. Nevertheless, there is no information regarding the basal incidence of this finding, to ascertain if could be eventually used as a potential marker of fluid overload. This protocol looks for the incidence of the finding of B-Lines, which are related to fluid overload, in patients undergoing open abdominal surgery.

Description:

The presence of B-lines will be observed in 4 spaces at each evaluation: Anterior-superior, and infero-lateral, by each side. The times of evaluation will be prior to intubation, after intubation, every one hour of surgery, at the end of the surgery prior to extubation, and after 2 hours in the postoperative care unit. Other variables addressed will be the vital signs, parameters related to a diminished intravascular status (ie, pulse pressure variability), central venous pressure, volume changes (reposition, bleeding, diuresis), and requirements of blood products. A correlation with baseline characteristics of patients will be observed; nevertheless, this study is directed as primary endpoint to evaluate the incidence of the B-lines in echography, and the sample size was calculated following this endpoint.

Recruitment information / eligibility
Status Recruiting
Enrollment 62
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients scheduled to open abdominal surgery Older than 18 years. Exclusion Criteria: - Previous thoracic surgery, BMI over 30 kg/m2 Baseline respiratory alterations related to preoperative supplementary oxygen requirements Evident malformations of the thoracic wall If the position required for the surgery does not allow the echographic windows required for the protocol

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Chile Hospital Clínico UC-Christus Santiago

Sponsors (1)
Lead Sponsor Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

Outcome
Type Measure Description Time frame Safety issue
Primary Apparition of pulmonary B-Lines 3 or more B-Lines in any evaluated quadrant During surgery and after 2 hours in the postoperative care unit
Secondary Postoperative pulmonary complications Requirements of supplementary oxygen at PACU discharge or postoperative mechanical ventilatory support After 2 hours in the postoperative care unit
Secondary fluid administration and B lines Correlation of fluid administration and appearance of B lines During surgery
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