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

Recruiting

• Conditions: Open Abdominal Surgery; Lung Ultrasound

• Registration Number: NCT06157138
• Lead Sponsor: Pontificia Universidad Catolica de Chile

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-11-27
• Study First Submitted QC: 2023-11-27
• Status Verified: 2023-12
• Study First Posted: 2023-12-05
• Study Start: 2023-12-26
• Last Update Submitted: 2023-12-26
• Last Update Posted: 2023-12-27
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 62

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Apparition of pulmonary B-Lines	During surgery and after 2 hours in the postoperative care unit	3 or more B-Lines in any evaluated quadrant

Secondary Outcome Measures

Name	Time	Method
Postoperative pulmonary complications	After 2 hours in the postoperative care unit	Requirements of supplementary oxygen at PACU discharge or postoperative mechanical ventilatory support
fluid administration and B lines	During surgery	Correlation of fluid administration and appearance of B lines

Trial Locations

Locations (1)

Hospital Clínico UC-Christus; 🇨🇱 Santiago, Chile