Pulmonary AtelectasisLUS-LPSNCT04116567
Lung Ultrasonography After Laparoscopic Gynecologic Surgery
An observational study of Pulmonary Atelectasis, run by SONNINO CHIARA at 1 site in Italy.
Trial summary
This study evaluates the influence of surgical and anesthesia-related variable on atelectasis formation during laparoscopic gynecologic oncologic surgery by lung ultrasound. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pulmonary Atelectasis
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 3 Oct 2018to 28 Jun 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All patients >18yo undergoing laparoscopy for ginecologic oncologic surgery willing to participate to the study
Who may be able to join
- Patients older than 18 yo undergoing laparoscopic surgery for gynecologic surgery who provide written informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Fondazione Policlinico Universitario Agostino Gemelli
Rome, 00168
About this study
Official title: 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.
Read the 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.
- Conditions
- Pulmonary Atelectasis
- Keywords
- Pulmonary Atelectasis, Lung Ultrasound, Laparoscopic Surgery
- Medical subject headings
- Pulmonary Atelectasis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: The outcome will be measured 10 minutes after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start3 Oct 2018
- Primary completion3 Oct 2018
- Study completion28 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary AtelectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- SONNINO CHIARA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, SONNINO CHIARA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Luciano Frassanito, MD, Principal investigator, IRCCS Fondazione Universitaria Policlinico Agostino GemelliGaetano Draisci, MD, PhD, Study director, IRCCS Fondazione Universitaria Policlinico Agostino Gemelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116567
- Sponsor's protocol ID
- 2560
- Acronym
- LUS-LPS
- Status last verified
- Oct 2021
- First submitted
- 27 Jul 2019
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasonography for the Assessment of Perioperative Atelectasis After Laparoscopic Gynecologic Oncologic Surgery
- ClinicalTrials.gov ID
- NCT04116567
- Acronym / sponsor ID
- LUS-LPS / 2560
- Conditions
- Pulmonary Atelectasis
- Keywords
- Pulmonary Atelectasis, Lung Ultrasound, Laparoscopic Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- SONNINO CHIARAUniversity, hospital or other
- Study start
- 3 Oct 2018 (actual)
- Primary completion
- 3 Oct 2018 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 4 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the influence of surgical and anesthesia-related variable on atelectasis formation during laparoscopic gynecologic oncologic surgery by lung ultrasound.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients >18yo undergoing laparoscopy for ginecologic oncologic surgery willing to participate to the study
Key inclusion criteria (1 listed)
- Patients older than 18 yo undergoing laparoscopic surgery for gynecologic surgery who provide written informed consent.
Key exclusion criteria (6 listed)
- age < 18 yo;
- pregnancy;
- refused to partecipate;
- known pulmonary metastasis;
- preexisting pulmonary conditions (COPD, pleural effusion, pulmonary consolidations, lung edema, pulmonary embolism);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess if LUS score measured after surgery is higher that LUS score measured before induction of anesthesia
Time frame: 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.
Correlation between the increase of LUS score after surgery and surgical or anesthesia-related variables.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luciano Frassanito, MD principal investigator
IRCCS Fondazione Universitaria Policlinico Agostino Gemelli
Gaetano Draisci, MD, PhD study director
IRCCS Fondazione Universitaria Policlinico Agostino Gemelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Atelectasis, run by SONNINO CHIARA at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess if LUS score measured after surgery is higher that LUS score measured before induction of anesthesia (time frame: The outcome will be measured 10 minutes after extubation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.