Lung Ultrasonography After Laparoscopic Gynecologic Surgery

Pulmonary Atelectasis Clinical Trial

— LUS-LPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04116567
• Other study ID #: 2560
• Status: Completed
• Start date: October 3, 2018
• Est. completion date: June 28, 2019

Study information

• Verified date: October 2021
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 28, 2019
• Est. primary completion date: October 3, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pulmonary Atelectasis

Locations

Country	Name	City	State
Italy	IRCCS Fondazione Policlinico Universitario Agostino Gemelli	Rome

Sponsors (1)

Lead Sponsor	Collaborator
SONNINO CHIARA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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