Lung Ultrasound and Alveolar Recruitment in Mechanically Ventilated Infants

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02584023
Collaborator
(none)
40
1
2
3
13.2

Study Details

Study Description

Brief Summary

Investigators hypothesized that lung ultrasound-assisted recruitment maneuver would be beneficial in mechanically ventilated infants compared to those who did not receive lung ultrasound and alveolar recruitment maneuver.

Condition or Disease Intervention/Treatment Phase
  • Device: Lung ultrasound
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Preventive Effect of Lung Ultrasound and Alveolar Recruitment on Atelectasis in Mechanically Ventilated Infants
Study Start Date :
Oct 1, 2015
Actual Primary Completion Date :
Jan 1, 2016
Actual Study Completion Date :
Jan 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Control

No intervention during the perioperative period. Perform lung ultrasound twice only for the diagnostic purpose after the endotracheal intubation and and at the end of surgery.

Device: Lung ultrasound
Lung ultrasound on both hemithorax in supine position

Active Comparator: Alveolar recruitment

Perform lung ultrasound twice during the perioperative period after the endotracheal intubation and and at the end of surgery. Conduct alveolar recruitment maneuver after first lung ultrasound assessment.

Device: Lung ultrasound
Lung ultrasound on both hemithorax in supine position

Outcome Measures

Primary Outcome Measures

  1. Postoperative incidence of pulmonary atelectasis [within the first day after the surgery]

Secondary Outcome Measures

  1. Intraoperative incidence of pulmonary atelectasis after endotracheal intubation [from the moment of endotracheal intubation until the end of surgery, up to 6 hours]

  2. Intraoperative incidence of pulse oximetry (SpO2) ≤ 95% (or 10% below the baseline value) [from the induction of general anesthesia until the end of the surgery, up to 6 hours]

  3. Postoperative incidence of pulse oximetry (SpO2) ≤ 95% (or 10% below the baseline value) [within the first day after the surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Day to 1 Year
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Minor surgery less than 2 hours under general anesthesia

  • Mechanically ventilated after endotracheal intubation

Exclusion Criteria:
  • History of surgery on the lungs

  • Laparoscopic surgery

  • Abnormal preoperative chest radiograph findings including atelectasis, pneumothorax, pleural effusion, and pneumonia

  • Considered inappropriate by the investigator

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Korea, Republic of 110-744

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

  • Principal Investigator: Jin-Tae Kim, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jin-Tae Kim, Associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT02584023
Other Study ID Numbers:
  • H-1509-063-703
First Posted:
Oct 22, 2015
Last Update Posted:
Jun 22, 2016
Last Verified:
Jun 1, 2016
Keywords provided by Jin-Tae Kim, Associate professor, Seoul National University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 22, 2016