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Completed

NCT Number: NCT04116567

Lung Ultrasonography After Laparoscopic Gynecologic Surgery

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

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Key information

Conditions

Pulmonary Atelectasis Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS Fondazione Policlinico Universitario Agostino Gemelli

Rome, 00168, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

SONNINO CHIARA

Other

Registry information

Official study title

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

Acronym: LUS-LPS

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Oct 4, 2019
Registry last updated
Nov 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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