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Completed

NCT Number: NCT03943433

Oxygen Concentration During Alveolar Recruitment

The purpose of this study is to investigate the effect of oxygen concentration during alveolar recruitment on absorption ateletasis.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing laparoscopic obstetric or colon surgery with Trendelenburg position

Exclusion criteria

  • American Society of Anesthesiologists physical status IV or more
  • Severe cardiovascular disease
  • Severe chronic obstructive pulmonary disease, emphysema
  • History of pneumothorax, bullae
  • History of lung resection surgery
  • Conversion to laparotomy
  • Refusal to participate

Treatment and study plan

FiO2_1.0

Procedure

Alveolar recruitment is performed with 100% oxygen concentration after general anesthesia induction, after position change to Trendelenburg, after position change to supine, and at the end of operation.

FiO2_0.4

Procedure

Alveolar recruitment is performed with 40% oxygen concentration after general anesthesia induction, after position change to Trendelenburg, after position change to supine, and at the end of operation.

Primary outcomes

  1. Modified lung ultrasound score

    Time frame: Intraoperative (at the end of operation, before emergence)

    The score is calculated by adding up the 12 individual quadrant scores assessed using lung ultrasound. Each quadrant score ranges from 0 (minimal atelectasis)~3 (severe atelectasis), so the maximum total score is 36.

Secondary outcomes

  1. Modified lung ultrasound score

    Time frame: Postoperative 30 minutes

    The score is calculated by adding up the 12 individual quadrant scores assessed using lung ultrasound. Each quadrant score ranges from 0 (minimal atelectasis)~3 (severe atelectasis), so the maximum total score is 36.

  2. Intraoperative desaturation

    Time frame: Intraoperative

    Oxygen saturation by pulse oximetry <95%

  3. Intraoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio

    Time frame: Intraoperative (20minutes after each recruitment)

    Partial pressure of arterial oxygen/fraction of inspired oxygen ratio

  4. Postoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio

    Time frame: Postoperative 30 minutes

    Partial pressure of arterial oxygen/fraction of inspired oxygen ratio

  5. Postoperative pulmonary complication

    Time frame: Postoperative 24 hours

    respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, atelectasis, bronchospasm, aspiration pneumonitis

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

The Effect of Oxygen Concentration During Alveolar Recruitment on Absorption Atelectasis

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 9, 2019
Registry last updated
Jul 14, 2020

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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