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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03486847
Other study ID # H-1802-088-923
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 29, 2018
Est. completion date July 31, 2019

Study information

Verified date April 2020
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date July 31, 2019
Est. primary completion date July 31, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 3 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Korea, Republic of SNUH Seoul Jongnogu

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of pre-extubation atelectasis Incidence of pre-extubation atelectasis accessed by lung ultrasound postoperative 10 minutes
Secondary Incidence of intraoperative atelectasis after intubation Incidence of intraoperative atelectasis after induction accessed by lung ultrasound intraoperative
Secondary Incidence of intraoperative atelectasis after position change to prone Incidence of intraoperative atelectasis after position change to prone accessed by lung ultrasound intraoperative
Secondary Incidence of intraoperative and postoperative (within 12hr) desaturation Oxygen saturation by pulse oximetry (SpO2) = 95% or 10% below the baseline value intraoperative and postoperative (within 12hr)
Secondary Incidence of intraoperative hypotension Systolic blood pressure (SBP) = 20% below the baseline value intraoperative
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