PregnancyVIRCANCT02714556
Changes in Ventilation Inhomogeneity and Respiratory Function Following Elective Caesarean Section Under Regional Anaesthesia
An observational study of Pregnancy, run by Walid HABRE at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Physiologic measures of lung function
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2016to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women scheduled for elective caesarean section in gestational weeks 37-40
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospitals of Geneva
Geneva, Canton of Geneva, 1206
About this study
Official title: Changes in Ventilation Inhomogeneity and Respiratory Function Following Elective Caesarean Section Under Regional Anaesthesia: a Prospective Observational Study
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.
Read the 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.
- Conditions
- Pregnancy
- Being tested
- Physiologic measures of lung function
- Keywords
- Lung volume, Lung Clearance Index, Functional Residual Capacity, Respiratory function
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiologic measures of lung functionOther
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative changes in ventilation inhomogeneity (LCI) following delivery by caesarean section
Nitrogen multiple breath washout technique
Measured: 1-3 days prior to caesarean section until 5 days postoperative
Secondary outcomes (5)
Alterations in FRC throughout the postpartum period
Nitrogen multiple breath washout technique
Measured: 1-3 days prior to caesarean section until 5 days postoperative
Changes in respiratory mechanics: respiratory system compliance (Crs)
Forced oscillation technique
Measured: 1-3 days prior to caesarean section until 5 days postoperatively
Changes in respiratory mechanics: airway resistance (Raw)
Forced oscillation technique
Measured: 1-3 days prior to caesarean section until 5 days postoperatively
Perioperative respiratory complications
Apnoea/bradypnoea, oxygen desaturation <90%/hypoxemia, hypoventilation/atelectasis, pulmonary embolism, incoercible cough
Measured: During caesarean section until 5 days postoperatively
Perioperative respiratory interventions
Intubation, oxygen therapy, bronchodilator, adrenaline, continuous positive airways pressure (CPAP), respiratory physiotherapy
Measured: During caesarean section until 5 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
Why it stopped: Ethical approval not obtained yet as questioning the danger of providing 100% oxygen to parturients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walid HABRE
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Walid HABRE, University Hospital, Geneva
- Investigators
- Walid Habre, MD, PhD, Study director, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714556
- Sponsor's protocol ID
- VIRCA-2016
- Acronym
- VIRCA
- Status last verified
- Oct 2016
- First submitted
- 1 Mar 2016
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Ventilation Inhomogeneity and Respiratory Function Following Elective Caesarean Section Under Regional Anaesthesia: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02714556
- Acronym / sponsor ID
- VIRCA / VIRCA-2016
- Conditions
- Pregnancy
- Keywords
- Lung volume, Lung Clearance Index, Functional Residual Capacity, Respiratory function
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Ethical approval not obtained yet as questioning the danger of providing 100% oxygen to parturients.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Walid HABREUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 21 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women scheduled for elective caesarean section in gestational weeks 37-40
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiologic measures of lung functionRespiratory 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) | Other | – |
Primary outcome
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
5 secondary outcomes
Alterations in FRC throughout the postpartum period
Time frame: 1-3 days prior to caesarean section until 5 days postoperative
Changes in respiratory mechanics: respiratory system compliance (Crs)
Time frame: 1-3 days prior to caesarean section until 5 days postoperatively
Changes in respiratory mechanics: airway resistance (Raw)
Time frame: 1-3 days prior to caesarean section until 5 days postoperatively
Perioperative respiratory complications
Time frame: During caesarean section until 5 days postoperatively
Perioperative respiratory interventions
Time frame: During caesarean section until 5 days postoperatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walid Habre, MD, PhD study director
University of Geneva, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Walid HABRE at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative changes in ventilation inhomogeneity (LCI) following delivery by caesarean section (time frame: 1-3 days prior to caesarean section until 5 days postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2016.