Lung Ultrasonography After Laparoscopic Gynecologic Surgery (LUS-LPS)

Lung Ultrasonography for the Assessment of Perioperative Atelectasis After Laparoscopic Gynecologic Oncologic Surgery

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

Study Overview

• Status: Completed
• Conditions: Pulmonary Atelectasis

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 Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00168
    • IRCCS Fondazione Policlinico Universitario Agostino Gemelli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

All patients >18yo undergoing laparoscopy for ginecologic oncologic surgery willing to participate to the study

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess if LUS score measured after surgery is higher that LUS score measured before induction of anesthesia	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.	The outcome will be measured 10 minutes after extubation
Correlation between the increase of LUS score after surgery and surgical or anesthesia-related variables.	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	The outcome will be measured 10 minutes after extubation

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (ACTUAL): October 3, 2018
• Primary Completion (ACTUAL): October 3, 2018
• Study Completion (ACTUAL): June 28, 2019

Study Registration Dates

• First Submitted: July 27, 2019
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (ACTUAL): October 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 1, 2021
• Last Update Submitted That Met QC Criteria: October 25, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Laparoscopic Surgery; Lung Ultrasound; Pulmonary Atelectasis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: 2560

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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