Postoperative Atelectasis in Pediatric Patients With Prone Position

NCT ID: NCT03486847

Last Updated: 2020-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-29

Study Completion Date

2019-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pulmonary Atelectasis, Postoperative Atelectasis, Compression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Repetitive recruitment with PEEP

One alveolar recruitment at before surgery and repetitive alveolar recruitment (once an hour) during surgery

Group Type EXPERIMENTAL

Repetitive recruitment with PEEP

Intervention Type 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

One alveolar recruitment at before surgery

Group Type ACTIVE_COMPARATOR

One recruitment with PEEP

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

One recruitment with PEEP

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

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hee-Soo Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hee Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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SNUH

Seoul, Jongnogu, South Korea

Site Status

Countries

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South Korea

References

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Jang YE, Ji SH, Kim EH, Lee JH, Kim JT, Kim HS. Effect of regular alveolar recruitment on intraoperative atelectasis in paediatric patients ventilated in the prone position: a randomised controlled trial. Br J Anaesth. 2020 May;124(5):648-655. doi: 10.1016/j.bja.2020.01.022. Epub 2020 Mar 10.

Reference Type DERIVED
PMID: 32169254 (View on PubMed)

Other Identifiers

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H-1802-088-923

Identifier Type: -

Identifier Source: org_study_id

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