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Postoperative Atelectasis in Pediatric Patients With Prone Position

Primary Purpose

Pulmonary Atelectasis, Postoperative, Atelectasis, Compression

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Repetitive recruitment with PEEP
One recruitment with PEEP
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pulmonary Atelectasis, Postoperative

Eligibility Criteria

undefined - 3 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • SNUH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Repetitive recruitment with PEEP

One recruitment with PEEP

Arm Description

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

One alveolar recruitment at before surgery

Outcomes

Primary Outcome Measures

Incidence of pre-extubation atelectasis
Incidence of pre-extubation atelectasis accessed by lung ultrasound

Secondary Outcome Measures

Incidence of intraoperative atelectasis after intubation
Incidence of intraoperative atelectasis after induction accessed by lung ultrasound
Incidence of intraoperative atelectasis after position change to prone
Incidence of intraoperative atelectasis after position change to prone accessed by lung ultrasound
Incidence of intraoperative and postoperative (within 12hr) desaturation
Oxygen saturation by pulse oximetry (SpO2) ≤ 95% or 10% below the baseline value
Incidence of intraoperative hypotension
Systolic blood pressure (SBP) ≤ 20% below the baseline value

Full Information

First Posted
March 26, 2018
Last Updated
April 15, 2020
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03486847
Brief Title
Postoperative Atelectasis in Pediatric Patients With Prone Position
Official Title
Postoperative Atelectasis in Pediatric Patients With Prone Position : Effect of Repetitive Alveolar Recruitment by Lung Ultrasound
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 29, 2018 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Atelectasis, Postoperative, Atelectasis, Compression

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Repetitive recruitment with PEEP
Arm Type
Experimental
Arm Description
One alveolar recruitment at before surgery and repetitive alveolar recruitment (once an hour) during surgery
Arm Title
One recruitment with PEEP
Arm Type
Active Comparator
Arm Description
One alveolar recruitment at before surgery
Intervention Type
Procedure
Intervention Name(s)
Repetitive recruitment with PEEP
Intervention Description
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
Intervention Name(s)
One recruitment with PEEP
Intervention Description
Apply sustained airway pressure of 30-40 cmH2O for 10-20 seconds before surgery. PEEP is set to 7 cmH2O.
Primary Outcome Measure Information:
Title
Incidence of pre-extubation atelectasis
Description
Incidence of pre-extubation atelectasis accessed by lung ultrasound
Time Frame
postoperative 10 minutes
Secondary Outcome Measure Information:
Title
Incidence of intraoperative atelectasis after intubation
Description
Incidence of intraoperative atelectasis after induction accessed by lung ultrasound
Time Frame
intraoperative
Title
Incidence of intraoperative atelectasis after position change to prone
Description
Incidence of intraoperative atelectasis after position change to prone accessed by lung ultrasound
Time Frame
intraoperative
Title
Incidence of intraoperative and postoperative (within 12hr) desaturation
Description
Oxygen saturation by pulse oximetry (SpO2) ≤ 95% or 10% below the baseline value
Time Frame
intraoperative and postoperative (within 12hr)
Title
Incidence of intraoperative hypotension
Description
Systolic blood pressure (SBP) ≤ 20% below the baseline value
Time Frame
intraoperative

10. Eligibility

Sex
All
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee Kim, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
SNUH
City
Seoul
State/Province
Jongnogu
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32169254
Citation
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.
Results Reference
derived

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Postoperative Atelectasis in Pediatric Patients With Prone Position

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