Fraction of Inspired Oxygen and Atelectasis in Children

Pulmonary Atelectasis Clinical Trial

Official title:

Effects of Fraction of Inspired Oxygen on Atelectasis in Mechanically Ventilated Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02870842
• Other study ID #: H-1607-150-778
• Status: Completed
• Phase: N/A
• First received: August 14, 2016
• Last updated: August 23, 2017
• Start date: September 2016
• Est. completion date: January 2017

Study information

• Verified date: August 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigators hypothesized that maintaining low fraction of inspired oxygen would be beneficial to prevent anesthesia-induced atelectasis in mechanically ventilated children undergoing general anesthesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 7 Years

Eligibility

Inclusion Criteria:

• Expected operation time between 1 to 3 hours under general anesthesia

• Mechanically ventilated after endotracheal intubation

Exclusion Criteria:

• Cardiac, thoracic, abdominal surgery

• 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

Related Conditions & MeSH terms

• Pulmonary Atelectasis

Intervention

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

Other:
• Respiratory management
Appropriate respiratory managements depending on the lung ultrasound findings

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

Acosta CM, Maidana GA, Jacovitti D, Belaunzarán 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. — View Citation

Akça O, Podolsky A, Eisenhuber E, Panzer O, Hetz H, Lampl K, Lackner FX, Wittmann K, Grabenwoeger F, Kurz A, Schultz AM, Negishi C, Sessler DI. Comparable postoperative pulmonary atelectasis in patients given 30% or 80% oxygen during and 2 hours after colon resection. Anesthesiology. 1999 Oct;91(4):991-8. — View Citation

Edmark L, Auner U, Enlund M, Ostberg E, Hedenstierna G. Oxygen concentration and characteristics of progressive atelectasis formation during anaesthesia. Acta Anaesthesiol Scand. 2011 Jan;55(1):75-81. doi: 10.1111/j.1399-6576.2010.02334.x. Epub 2010 Oct 29. Erratum in: Acta Anaesthesiol Scand. 2011 Jul;55(6):766. — View Citation

Martin JB, Garbee D, Bonanno L. Effectiveness of positive end-expiratory pressure, decreased fraction of inspired oxygen and vital capacity recruitment maneuver in the prevention of pulmonary atelectasis in patients undergoing general anesthesia: a systematic review. JBI Database System Rev Implement Rep. 2015 Sep 16;13(8):211-49. doi: 10.11124/jbisrir-2015-1410. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative atelectasis		within the first day after the surgery
Secondary	Incidence of atelectasis after endotracheal intubation		from the moment of endotracheal intubation until the end of surgery, up to 4 hours
Secondary	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 4 hours
Secondary	Postoperative incidence of pulse oximetry (SpO2) = 95% (or 10% below the baseline value)		within the first day after the surgery
Secondary	Postoperative incidence of fever (=37.5?)		within the first day after the surgery
Secondary	Postoperative incidence of respiratory complications		within the first day after the surgery