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LUS-LPS: Lung Ultrasonography After Laparoscopic Gynecologic Surgery

Sponsor
SONNINO CHIARA (Other)
Overall Status
Completed
CT.gov ID
NCT04116567
Collaborator
(none)
80
Enrollment
1
Location
8.8
Actual Duration (Months)
9.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluates the influence of surgical and anesthesia-related variable on atelectasis formation during laparoscopic gynecologic oncologic surgery by lung ultrasound.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Approximately 50% of patients undergoing general anesthesia are hypoxemic. Anaesthesia, paralysis, high concentrations of oxygen, inadequate level of PEEP, capnoperitoneum, Trendelenburg position all result in persistent atelectasis. Lung ultrasound is a safe and accurate bedside tool useful to study lung aeration. The aim of the investigator's study was to assess the impact of general anesthesia and laparoscopic gynecologic oncologic surgery on post-operative atelectasis and related oxygenation changes using lung ultrasound.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    80 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Lung Ultrasonography for the Assessment of Perioperative Atelectasis After Laparoscopic Gynecologic Oncologic Surgery
    Actual Study Start Date :
    Oct 3, 2018
    Actual Primary Completion Date :
    Oct 3, 2018
    Actual Study Completion Date :
    Jun 28, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Assess if LUS score measured after surgery is higher that LUS score measured before induction of anesthesia [The outcome will be measured 10 minutes after extubation]

      Each lung will be divided in 6 areas and a score from 0 to 3 will be assigned to each field depending on the loss of aereation detected by ultrasound. LUS score will range between 0 and 36. Lung ultrasound will be performed before induction of anesthesia and 10 minutes after extubation.

    2. Correlation between the increase of LUS score after surgery and surgical or anesthesia-related variables. [The outcome will be measured 10 minutes after extubation]

      Logistic regression will be applied to consider the correlation between Delta LUS and the following variables: lenght of surgery duration of pneumoperitoneum angle of Trendelenburg potision duration of mechanical ventilation intraoperative fluids duration of apnea from induction to intubation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients older than 18 yo undergoing laparoscopic surgery for gynecologic surgery who provide written informed consent.
    Exclusion Criteria:

    • age < 18 yo;

    • pregnancy;

    • refused to partecipate;

    • known pulmonary metastasis;

    • preexisting pulmonary conditions (COPD, pleural effusion, pulmonary consolidations, lung edema, pulmonary embolism);

    • anesthesia with mechanical ventilation in the 2 weeks.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IRCCS Fondazione Policlinico Universitario Agostino Gemelli Rome Italy 00168

    Sponsors and Collaborators

    • SONNINO CHIARA

    Investigators

    • Principal Investigator: Luciano Frassanito, MD, IRCCS Fondazione Universitaria Policlinico Agostino Gemelli
    • Study Director: Gaetano Draisci, MD, PhD, IRCCS Fondazione Universitaria Policlinico Agostino Gemelli

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    SONNINO CHIARA, Registered Anesthesiologist, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    ClinicalTrials.gov Identifier:
    NCT04116567
    Other Study ID Numbers:
    • 2560
    First Posted:
    Oct 4, 2019
    Last Update Posted:
    Nov 1, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by SONNINO CHIARA, Registered Anesthesiologist, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    Pulmonary Atelectasis
    Lung Ultrasound
    Laparoscopic Surgery
    Additional relevant MeSH terms:
    Pulmonary Atelectasis

    Study Results

    No Results Posted as of Nov 1, 2021