Clinical trial NCT02870842: Fraction of Inspired Oxygen and Atelectasis in Children
Official title: Effects of Fraction of Inspired Oxygen on Atelectasis in Mechanically Ventilated Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Atelectasis
Keywords: ultrasonography
child
perioperative period
general anesthesia
lung
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-08-17
Enrollment: 86
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of postoperative atelectasis
timeFrame: within the first day after the surgery
Secondary outcomes:
measure: Incidence of atelectasis after endotracheal intubation
timeFrame: from the moment of endotracheal intubation until the end of surgery, up to 4 hours
measure: Intraoperative incidence of pulse oximetry (SpO2) ≤ 95% (or 10% below the baseline value)
timeFrame: from the induction of general anesthesia until the end of the surgery, up to 4 hours
measure: Postoperative incidence of pulse oximetry (SpO2) ≤ 95% (or 10% below the baseline value)
timeFrame: within the first day after the surgery
measure: Postoperative incidence of fever (≥37.5℃)
timeFrame: within the first day after the surgery
measure: Postoperative incidence of respiratory complications
timeFrame: within the first day after the surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: Akca 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. doi: 10.1097/00000542-199910000-00019.
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.