Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-02-25 @ 8:20 PM
Study NCT ID:
NCT02714556
Status:
WITHDRAWN
Last Update Posted:
2016-11-01
First Post:
2016-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes in Ventilation Inhomogeneity and Respiratory Function Following Elective Caesarean Section Under Regional Anaesthesia
Sponsor:
Walid HABRE
Organization:
Study Overview
Official Title:
Changes in Ventilation Inhomogeneity and Respiratory Function Following Elective Caesarean Section Under Regional Anaesthesia: a Prospective Observational Study
Status:
WITHDRAWN
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Ethical approval not obtained yet as questioning the danger of providing 100% oxygen to parturients.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIRCA
Brief Summary:
Pregnancy is associated with physiological changes affecting the cardiorespiratory system as a consequence of an increase in both cardiac output and intra-abdominal pressure. The aim of this prospective observational study is to examine the perioperative changes in ventilation inhomogeneity and respiratory function measured by the non-invasive nitrogen multiple breath washout and forced oscillation techniques.
Detailed Description:
Pregnancy is associated with physiological changes affecting the cardiorespiratory system as a consequence of an increase in both cardiac output and intra-abdominal pressure. These alterations lead to a ventilation/perfusion mismatch which is potentiated by a decrease in functional residual capacity (FRC). These effects explain why pregnant women are more prone to the occurrence of hypoxemia, particularly in the third trimester of their pregnancy. The importance of the ventilation inhomogeneity can be estimated from the lung clearance index (LCI) measured by the non-invasive nitrogen multiple breath washout (N2 MBW) technique. Moreover the loss in lung volume is associated with reduction in respiratory system compliance, which can also be assessed non-invasively by the forced oscillation technique (FOT).
To our knowledge, there is no existing data on LCI or FRC using the aforementioned techniques in pregnant women. Furthermore, existing data on respiratory function in pregnant women is largely restricted to spirometric and body plethysmographic measurements taken primarily in the 1970s-1980s. As such, the important roles of lung ventilation inhomogeneity as well as the potential changes following birth after caesarean section have yet to be completely characterised.
To our knowledge, there is no existing data on LCI or FRC using the aforementioned techniques in pregnant women. Furthermore, existing data on respiratory function in pregnant women is largely restricted to spirometric and body plethysmographic measurements taken primarily in the 1970s-1980s. As such, the important roles of lung ventilation inhomogeneity as well as the potential changes following birth after caesarean section have yet to be completely characterised.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: