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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04116567
Other study ID # 2560
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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