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Completed

NCT Number: NCT03607240

Ultrasound-guided Alveolar Recruitment in Laparoscopic Gynecological Surgery

The study aims to compare the degree of atelectasis between ultrasound-guided alveolar recruitment group and conventional alveolar recruitment group in patients receiving laparoscopic gynecologic surgery

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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

Interventional

Phase

Not applicable

Primary location

Jin-Tae Kim, Seoul, South Korea

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients scheduled to undergo elective laparoscopic gynecological surgery (laparoscopic ovarian cystectomy or laparoscopic salpingo-oophorectomy or laparoscopic hysterectomy or laparoscopic myomectomy) under general anesthesia, with ASA physical status classification I or II

Exclusion criteria

  • Previous history of lung surgery
  • Patients having pneumonia, pneumothorax, or pleural effusion in preoperative chest X-ray
  • Patients with COPD, emphysema
  • Patients with previous history of pneumothorax, or bullae
  • Morbid cardiac disease
  • Adolescent aged < 18 years
  • Anticipated duration of surgery < 1 hour

Treatment and study plan

lung ultrasound-guided alveolar recruitment

Procedure

Alveolar recruitment maneuver will be performed under lung ultrasound-guidance. Positive pressure will be not exceed 40cmH2O and duration of positive pressure inflation will not exceed 10 seconds.

conventional alveolar recruitment

Procedure

Alveolar recruitment will be provided with positive pressure of 30cmH2O for 10 seconds

Primary outcomes

  1. modified lung ultrasound score at the end of surgery

    Time frame: At the end of surgery

    Both lung ultrasound scores can be calculated by adding up the 12 individual pulmonary quadrant scores yielding a score between 0 (no aeration loss) and 36 (complete aeration loss).

Secondary outcomes

  1. modified lung ultrasound score at post-anesthesia care unit (PACU)

    Time frame: intraoperative

    Both lung ultrasound scores can be calculated by adding up the 12 individual pulmonary quadrant scores yielding a score between 0 (no aeration loss) and 36 (complete aeration loss).

  2. incidence of atelectasis diagnosed by ultrasonography

    Time frame: intraoperative

    the presence of atelectasis by ultrasonography

  3. arterial blood gas analyses

    Time frame: intraoperative

    PaO2, PaCO2, SaO2, O2 index (PaO2/FiO2)

  4. incidence of postoperative complications

    Time frame: during the postoperative period until discharge from hospital, an average of 3 days

    fever, pneumonia, atelectasis diagnosed by chest X-ray

  5. intraoperative mean arterial pressure

    Time frame: intraoperative

    mean arterial pressure in mmHg

  6. intraoperative SpO2

    Time frame: intraoperative

    SpO2 in %

  7. intraoperative peak airway pressure

    Time frame: intraoperative

    peak airway pressure in cmH2O

  8. Incidence of postoperative shoulder pain at POD #1

    Time frame: assessed at postoperative day 1

    patients will be asked whether they have shoulder pain or not, using NRS (0 to 10) scale

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

The Effect of Ultrasound-guided Alveolar Recruitment on Postoperative Atelectasis in Patients Receiving Laparoscopic Gynecological Surgery

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 31, 2018
Registry last updated
Oct 18, 2019

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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