Lung Ultrasonography After Laparoscopic Gynecologic Surgery

NCT04116567 | Completed

• 1 other identifier: 2560
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulmonary Atelectasis

Keywords

Pulmonary Atelectasis; Lung Ultrasound; Laparoscopic Surgery

Outcome Measures

Primary Outcomes (2)

• 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

Eligibility Criteria

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

Study Population

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

You may qualify if:

• Patients older than 18 yo undergoing laparoscopic surgery for gynecologic surgery who provide written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SONNINO CHIARA: lead

Study Sites (1)

IRCCS Fondazione Policlinico Universitario Agostino Gemelli

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Luciano Frassanito, MD

  IRCCS Fondazione Universitaria Policlinico Agostino Gemelli

  PRINCIPAL INVESTIGATOR

• Gaetano Draisci, MD, PhD

  IRCCS Fondazione Universitaria Policlinico Agostino Gemelli

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Registered Anesthesiologist

Study Record Dates

• First Submitted: July 27, 2019
• First Posted: October 4, 2019
• Study Start: October 3, 2018
• Primary Completion: October 3, 2018
• Study Completion: June 28, 2019
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

IT (1)