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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Lung Ultrasound
• Open Abdominal Surgery

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