Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02714556
Recruitment Status : Withdrawn (Ethical approval not obtained yet as questioning the danger of providing 100% oxygen to parturients.)
First Posted : March 21, 2016
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
Walid HABRE, University Hospital, Geneva

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.

Condition or disease Intervention/treatment
Pregnancy Other: Physiologic measures of lung function

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Changes in Ventilation Inhomogeneity and Respiratory Function Following Elective Caesarean Section Under Regional Anaesthesia: a Prospective Observational Study
Study Start Date : May 2016
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section


Intervention Details:
  • Other: Physiologic 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)



Primary Outcome Measures :
  1. Perioperative changes in ventilation inhomogeneity (LCI) following delivery by caesarean section [ Time Frame: 1-3 days prior to caesarean section until 5 days postoperative ]
    Nitrogen multiple breath washout technique


Secondary Outcome Measures :
  1. Alterations in FRC throughout the postpartum period [ Time Frame: 1-3 days prior to caesarean section until 5 days postoperative ]
    Nitrogen multiple breath washout technique

  2. Changes in respiratory mechanics: respiratory system compliance (Crs) [ Time Frame: 1-3 days prior to caesarean section until 5 days postoperatively ]
    Forced oscillation technique

  3. Changes in respiratory mechanics: airway resistance (Raw) [ Time Frame: 1-3 days prior to caesarean section until 5 days postoperatively ]
    Forced oscillation technique

  4. Perioperative respiratory complications [ Time Frame: During caesarean section until 5 days postoperatively ]
    Apnoea/bradypnoea, oxygen desaturation <90%/hypoxemia, hypoventilation/atelectasis, pulmonary embolism, incoercible cough

  5. Perioperative respiratory interventions [ Time Frame: During caesarean section until 5 days postoperatively ]
    Intubation, oxygen therapy, bronchodilator, adrenaline, continuous positive airways pressure (CPAP), respiratory physiotherapy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women scheduled for elective caesarean section in gestational weeks 37-40
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714556


Locations
Layout table for location information
Switzerland
University Hospitals of Geneva
Geneva, Switzerland, 1206
Sponsors and Collaborators
Walid HABRE
Investigators
Layout table for investigator information
Study Director: Walid Habre, MD, PhD University of Geneva
Layout table for additonal information
Responsible Party: Walid HABRE, Professor, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT02714556    
Other Study ID Numbers: VIRCA-2016
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Walid HABRE, University Hospital, Geneva:
Lung volume
Lung Clearance Index
Functional Residual Capacity
Respiratory function