Observation of B-lines in Pulmonary Echography, During Open Abdominal Surgery (LUS-SURG)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Ultrasound; 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 Type: Observational
• Enrollment (Estimated): 62

Contacts and Locations

• Study Contact: Name: Augusto Rolle, MD; Phone Number: 56+95504 3414; Email: ajrolle@uc.cl
• Study Contact Backup: Name: Ana M Oliveros, MD; Phone Number: 56+95504 3414; Email: aolivero@uc.cl

Study Locations

• Chile
  • Santiago, Chile, 8320165
    • Recruiting
    • Hospital Clínico UC-Christus
    • Contact: Augusto Rolle, MD; Phone Number: 56+955043414; Email: ajrolle@uc.cl
    • Principal Investigator: Augusto Rolle, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled to open abdominal surgery

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients undergoing open abdominal surgery; Patients older than 18 years undergoing open abdominal surgery. They will be followed by a protocol of pulmonary echography during and after surgery in the postoperative care unit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pontificia Universidad Catolica de Chile
• Investigators: Principal Investigator: Augusto Rolle, MD, Pontificia Universidad Catolica de Chile

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: November 27, 2023
• First Posted (Actual): December 5, 2023

Study Record Updates

• Last Update Posted (Actual): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 26, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: lung ultrasound; B-Lines
• Other Study ID Numbers: 230209001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not required; all the data will be managed by the research team

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No