Skip to content

Changes in Ventilation Inhomogeneity and Respiratory Function Following Elective Caesarean Section Under Regional Anaesthesia

Changes in Ventilation Inhomogeneity and Respiratory Function Following Elective Caesarean Section Under Regional Anaesthesia: a Prospective Observational Study

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02714556
Acronym
VIRCA
Enrollment
0
Registered
2016-03-21
Start date
2016-05-31
Completion date
2016-10-31
Last updated
2016-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

Lung volume, Lung Clearance Index, Functional Residual Capacity, Respiratory function

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.

Interventions

OTHERPhysiologic measures of lung function

Respiratory function tests: Nitrogen multiple breath washout (N2MBW) measured with an ultrasonic flowmeter (Exhalyzer D with ICU insert, Eco Medics, Duernten, Switzerland) Forced oscillation technique (FOT) measured with a tremoFlo device (Thorasys, Montreal, Canada)

Sponsors

Walid HABRE
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Written informed consent * Pregnant woman in the third trimester (37-40 weeks gestational age) * Scheduled for elective caesarean section under regional (spinal or combined spinal-epidural) anaesthesia

Exclusion criteria

* Pregnant women outside 37-40 weeks gestational age * Non-singleton pregnancy * Previous history of ≥2 caesarean sections * History or clinical signs of cardiopulmonary disease in the last 12 months (chronic hypertension, gestational hypertension, preeclampsia, asthma, acute or chronic bronchitis, others) * Positive current smoking status * Pre-pregnant body mass index (BMI) \>30 kg/m2 (based on booking records) * Respiratory infection \<2 weeks prior to surgery * Inability to perform the respiratory function tests

Design outcomes

Primary

MeasureTime frameDescription
Perioperative changes in ventilation inhomogeneity (LCI) following delivery by caesarean section1-3 days prior to caesarean section until 5 days postoperativeNitrogen multiple breath washout technique

Secondary

MeasureTime frameDescription
Alterations in FRC throughout the postpartum period1-3 days prior to caesarean section until 5 days postoperativeNitrogen multiple breath washout technique
Changes in respiratory mechanics: respiratory system compliance (Crs)1-3 days prior to caesarean section until 5 days postoperativelyForced oscillation technique
Changes in respiratory mechanics: airway resistance (Raw)1-3 days prior to caesarean section until 5 days postoperativelyForced oscillation technique
Perioperative respiratory complicationsDuring caesarean section until 5 days postoperativelyApnoea/bradypnoea, oxygen desaturation \<90%/hypoxemia, hypoventilation/atelectasis, pulmonary embolism, incoercible cough
Perioperative respiratory interventionsDuring caesarean section until 5 days postoperativelyIntubation, oxygen therapy, bronchodilator, adrenaline, continuous positive airways pressure (CPAP), respiratory physiotherapy

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026