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

NCT06157138 | Unknown

• 1 other identifier: 230209001
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Open Abdominal Surgery; Lung Ultrasound

Keywords

lung ultrasound; B-Lines

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Postoperative pulmonary complications

  After 2 hours in the postoperative care unit

• fluid administration and B lines

  During surgery

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled to open abdominal surgery

You may qualify if:

• Patients scheduled to open abdominal surgery Older than 18 years.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Hospital Clínico UC-Christus

Santiago, 8320165, Chile

RECRUITING

Study Officials

• Augusto Rolle, MD

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Augusto Rolle, MD

CONTACT

56+95504 3414; ajrolle@uc.cl

Ana M Oliveros, MD

CONTACT

56+95504 3414; aolivero@uc.cl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 5, 2023
• Study Start: December 26, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 27, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)