MedDataX Logo

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

NCT ID: NCT06157138

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-26

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Open Abdominal Surgery Lung Ultrasound

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

lung ultrasound B-Lines

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Augusto Rolle

MD, MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Augusto Rolle, MD

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidad Catolica de Chile

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Clínico UC-Christus

Santiago, , Chile

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Chile

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Augusto Rolle, MD

Role: CONTACT

Phone: 56+95504 3414

Email: [email protected]

Ana M Oliveros, MD

Role: CONTACT

Phone: 56+95504 3414

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Augusto Rolle, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

230209001

Identifier Type: -

Identifier Source: org_study_id