Lung Ultrasound and Alveolar Recruitment in Mechanically Ventilated Infants

NCT ID: NCT02584023

Last Updated: 2016-06-22

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Atelectasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type PLACEBO_COMPARATOR

Lung ultrasound

Intervention Type DEVICE

Lung ultrasound on both hemithorax in supine position

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.

Group Type ACTIVE_COMPARATOR

Lung ultrasound

Intervention Type DEVICE

Lung ultrasound on both hemithorax in supine position

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lung ultrasound

Lung ultrasound on both hemithorax in supine position

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

1 Day

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jin-Tae Kim

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jin-Tae Kim

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Seoul National University Hospital

Seoul, Seoul, South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

References

Explore related publications, articles, or registry entries linked to this study.

Lutterbey G, Wattjes MP, Doerr D, Fischer NJ, Gieseke J Jr, Schild HH. Atelectasis in children undergoing either propofol infusion or positive pressure ventilation anesthesia for magnetic resonance imaging. Paediatr Anaesth. 2007 Feb;17(2):121-5. doi: 10.1111/j.1460-9592.2006.02045.x.

Reference Type BACKGROUND
PMID: 17238882 (View on PubMed)

Magnusson L, Spahn DR. New concepts of atelectasis during general anaesthesia. Br J Anaesth. 2003 Jul;91(1):61-72. doi: 10.1093/bja/aeg085. No abstract available.

Reference Type BACKGROUND
PMID: 12821566 (View on PubMed)

Tusman G, Bohm SH, Tempra A, Melkun F, Garcia E, Turchetto E, Mulder PG, Lachmann B. Effects of recruitment maneuver on atelectasis in anesthetized children. Anesthesiology. 2003 Jan;98(1):14-22. doi: 10.1097/00000542-200301000-00006.

Reference Type BACKGROUND
PMID: 12502973 (View on PubMed)

Ashton-Cleary DT. Is thoracic ultrasound a viable alternative to conventional imaging in the critical care setting? Br J Anaesth. 2013 Aug;111(2):152-60. doi: 10.1093/bja/aet076. Epub 2013 Apr 12.

Reference Type BACKGROUND
PMID: 23585400 (View on PubMed)

Kiley S, Cassara C, Fahy BG. Lung ultrasound in the intensive care unit. J Cardiothorac Vasc Anesth. 2015 Feb;29(1):196-203. doi: 10.1053/j.jvca.2014.10.017. No abstract available.

Reference Type BACKGROUND
PMID: 25620145 (View on PubMed)

Acosta CM, Maidana GA, Jacovitti D, Belaunzaran A, Cereceda S, Rae E, Molina A, Gonorazky S, Bohm SH, Tusman G. Accuracy of transthoracic lung ultrasound for diagnosing anesthesia-induced atelectasis in children. Anesthesiology. 2014 Jun;120(6):1370-9. doi: 10.1097/ALN.0000000000000231.

Reference Type BACKGROUND
PMID: 24662376 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H-1509-063-703

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Ultrasound Assessment of BC in the NICU
NCT03241082 ACTIVE_NOT_RECRUITING
Lung Ultrasound - Prospective Study
NCT06140615 RECRUITING NA
LUS AT BIRTH IN INFANTS BORN BEFORE 26 WEEKS
NCT06394583 NOT_YET_RECRUITING