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

NCT02714556 | Withdrawn

• 1 other identifier: VIRCA-2016
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Perioperative changes in ventilation inhomogeneity (LCI) following delivery by caesarean section

  Nitrogen multiple breath washout technique

  1-3 days prior to caesarean section until 5 days postoperative

Secondary Outcomes (5)

• Alterations in FRC throughout the postpartum period

  1-3 days prior to caesarean section until 5 days postoperative

• Changes in respiratory mechanics: respiratory system compliance (Crs)

  1-3 days prior to caesarean section until 5 days postoperatively

• Changes in respiratory mechanics: airway resistance (Raw)

  1-3 days prior to caesarean section until 5 days postoperatively

• Perioperative respiratory complications

  During caesarean section until 5 days postoperatively

• Perioperative respiratory interventions

  During caesarean section until 5 days postoperatively

Interventions

Physiologic measures of lung function OTHER

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women scheduled for elective caesarean section in gestational weeks 37-40

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Walid HABRE: lead

Study Sites (1)

University Hospitals of Geneva

Geneva, Canton of Geneva, 1206, Switzerland

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Walid Habre, MD, PhD

  University of Geneva

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 1, 2016
• First Posted: March 21, 2016
• Study Start: May 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 1, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)