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

Sponsor
Pontificia Universidad Catolica de Chile (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06157138
Collaborator
(none)
62
Enrollment
1
Location
12
Anticipated Duration (Months)
5.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 (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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    62 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Incidence of B-Lines in Pulmonary Echography, in Patients Undergoing Open Abdominal Surgery.
    Anticipated Study Start Date :
    Dec 1, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Clínico UC-Christus Santiago Chile 8320165

    Sponsors and Collaborators

    • Pontificia Universidad Catolica de Chile

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Augusto Rolle, MD, MSc, Pontificia Universidad Catolica de Chile
    ClinicalTrials.gov Identifier:
    NCT06157138
    Other Study ID Numbers:
    • 230209001
    First Posted:
    Dec 5, 2023
    Last Update Posted:
    Dec 5, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Augusto Rolle, MD, MSc, Pontificia Universidad Catolica de Chile
    lung ultrasound
    B-Lines

    Study Results

    No Results Posted as of Dec 5, 2023