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Completed

NCT Number: NCT03486847

Postoperative Atelectasis in Pediatric Patients With Prone Position

This study evaluates the incidence of postoperative atelectasis after general anesthesia with prone position using lung ultrasound in children age < 3 years.

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Key information

Age range

Up to 3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SNUH

Seoul, Jongnogu, 03080, South Korea

About this study

Atelectasis is common in pediatric patients after general anesthesia. Particularly, infants are more likely to develop atelectasis or ventilation-perfusion imbalance after general anesthesia because of the immature ribs and respiratory muscles, the high compliance of the rib cage and a significant reduction in functional residual capacity (FRC) during general anesthesia. Previous studies have reported that alveolar recruitment and positive end-expiratory pressure (PEEP) can be used to reduce atelectasis in children. Also, previous studies have shown that the lung ultrasound can be used to evaluate the degree of atelectasis during general anesthesia in children.

However, none of the previous studies investigated the incidence of atelectasis, the effect of alveolar recruitment, and the PEEP in pediatric patients under general anesthesia with prone position. The purpose of this study was to evaluate previously described parameters using lung ultrasound.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children undergoing general anesthesia with prone position
  • Endotracheal intubation and mechanical ventilation during general anesthesia
  • Operation time is more than 2 hours

Exclusion criteria

  • Previous lung surgery
  • Any abnormal findings such as atelectasis, pneumothorax, pleural effusion, or pneumonia on preoperative chest X-ray
  • Researchers judge (to be inappropriate)

Treatment and study plan

Repetitive recruitment with PEEP

Procedure

Apply sustained airway pressure of 30-40 cmH2O for 10-20 seconds before suegery and once an hour during surgery. PEEP is set to 7 cmH2O.

One recruitment with PEEP

Procedure

Apply sustained airway pressure of 30-40 cmH2O for 10-20 seconds before surgery. PEEP is set to 7 cmH2O.

Primary outcomes

  1. Incidence of pre-extubation atelectasis

    Time frame: postoperative 10 minutes

    Incidence of pre-extubation atelectasis accessed by lung ultrasound

Secondary outcomes

  1. Incidence of intraoperative atelectasis after intubation

    Time frame: intraoperative

    Incidence of intraoperative atelectasis after induction accessed by lung ultrasound

  2. Incidence of intraoperative atelectasis after position change to prone

    Time frame: intraoperative

    Incidence of intraoperative atelectasis after position change to prone accessed by lung ultrasound

  3. Incidence of intraoperative and postoperative (within 12hr) desaturation

    Time frame: intraoperative and postoperative (within 12hr)

    Oxygen saturation by pulse oximetry (SpO2) ≤ 95% or 10% below the baseline value

  4. Incidence of intraoperative hypotension

    Time frame: intraoperative

    Systolic blood pressure (SBP) ≤ 20% below the baseline value

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Postoperative Atelectasis in Pediatric Patients With Prone Position : Effect of Repetitive Alveolar Recruitment by Lung Ultrasound

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 3, 2018
Registry last updated
Apr 16, 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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