Postoperative Atelectasis in Pediatric Patients With Prone Position

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

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

Study Overview

• Status: Completed
• Conditions: Pulmonary Atelectasis, Postoperative; Atelectasis, Compression
• Intervention / Treatment: Procedure: Repetitive recruitment with PEEP; Procedure: One recruitment with PEEP

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.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jongnogu
    • Seoul, Jongnogu, Korea, Republic of, 03080
      • SNUH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Repetitive recruitment with PEEP; One alveolar recruitment at before surgery and repetitive alveolar recruitment (once an hour) during surgery	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.
Active Comparator: One recruitment with PEEP; One alveolar recruitment at before surgery	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of pre-extubation atelectasis	Incidence of pre-extubation atelectasis accessed by lung ultrasound	postoperative 10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of intraoperative atelectasis after intubation	Incidence of intraoperative atelectasis after induction accessed by lung ultrasound	intraoperative
Incidence of intraoperative atelectasis after position change to prone	Incidence of intraoperative atelectasis after position change to prone accessed by lung ultrasound	intraoperative
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)
Incidence of intraoperative hypotension	Systolic blood pressure (SBP) ≤ 20% below the baseline value	intraoperative

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Hee Kim, MD, Seoul National University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2018
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: March 26, 2018
• First Submitted That Met QC Criteria: April 1, 2018
• First Posted (Actual): April 3, 2018

Study Record Updates

• Last Update Posted (Actual): April 16, 2020
• Last Update Submitted That Met QC Criteria: April 15, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: H-1802-088-923

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No