Pre-oxygenation in Term Pregnant WomenTHRIVEN90NCT04229745
Clinical Trial of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Oxygen in Women Having Planned Caesarean Delivery
An observational study of Pre-oxygenation in Term Pregnant Women, run by SABA AL-SULTTAN at 1 site in United Kingdom.
Trial summary
Clinical Trial of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Oxygen in Women having Planned Caesarean Delivery. Cohort study investigating the efficacy of THRIVE pre-oxygenation using pre-determined number of vital capacity breaths and comparing the efficacy to face mask pre-oxygenation. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pre-oxygenation in Term Pregnant Women
- What is being tested?
- THRIVE pre-oxygenation
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Oct 2018to 23 Jun 2019
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: term pregnant women undergoing elective Caesarean section
Who may be able to join
- scheduled to undergo elective caesarean delivery
- singleton pregnancy
- American Society of Anaesthesiologists (ASA) Physical Status Grade II
- gestational age between 37 - 42 weeks
Who cannot join
- multiple pregnancy
- pre-eclampsia
- known fetal abnormality
- maternal cardio-respiratory comorbidity
- Body Mass Index (BMI) > 35 kg/m2.
Trial locations and contacts
1 site in 1 country.
About this study
Clinical Trial of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Oxygen in Women having Planned Caesarean Delivery. Cohort study investigating the efficacy of THRIVE pre-oxygenation using pre-determined number of vital capacity breaths and comparing the efficacy to face mask pre-oxygenation. Aimed to recruit ASA 1-2 term pregnant women having elective caesarean section.
- Conditions
- Pre-oxygenation in Term Pregnant Women
- Being tested
- THRIVE pre-oxygenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THRIVE pre-oxygenationDevice
Clinical Trial of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Oxygen in Women having Planned Caesarean Delivery
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of vital capacity breaths required using THRIVE to pre-oxygenate 90% of parturients to an end tidal oxygen concentration of ≥90% (EN90). End tidal oxygen concentration >= 0.9
measure end tidal oxygen concentration through breathing system attached to anaesthetic machine
Measured: 8 months study period
Secondary outcomes (3)
EN90 using THRIVE with mouth open versus mouth closed
to measure any difference in end tidal oxygen concentration after using THRIVE mouth closed versus THRIVE mouth open
Measured: 8 months study period
comfort score of THRIVE
using 4-point Likert scale (1 being very uncomfortable- 4 comfortable)
Measured: 8 months study period
changes in fetal wellbeing during pre-oxygenation time
using fetal cardiotocography
Measured: 8 months study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start25 Oct 2018
- Primary completion23 Jun 2019
- Study completion23 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-oxygenation in Term Pregnant WomenStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- SABA AL-SULTTAN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, SABA AL-SULTTAN, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229745
- Sponsor's protocol ID
- 18/0042
- Acronym
- THRIVEN90
- Status last verified
- Jan 2020
- First submitted
- 26 Nov 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Oxygen in Women Having Planned Caesarean Delivery
- ClinicalTrials.gov ID
- NCT04229745
- Acronym / sponsor ID
- THRIVEN90 / 18/0042
- Conditions
- Pre-oxygenation in Term Pregnant Women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- SABA AL-SULTTANUniversity, hospital or other
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 23 Jun 2019 (actual)
- Study completion
- 23 Jun 2019 (actual)
- First posted
- 18 Jan 2020 (actual)
- 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.
Clinical Trial of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Oxygen in Women having Planned Caesarean Delivery. Cohort study investigating the efficacy of THRIVE pre-oxygenation using pre-determined number of vital capacity breaths and comparing the efficacy to face mask pre-oxygenation. Aimed to recruit ASA 1-2 term pregnant women having elective caesarean section.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- term pregnant women undergoing elective Caesarean section
Key inclusion criteria (4 listed)
- scheduled to undergo elective caesarean delivery
- singleton pregnancy
- American Society of Anaesthesiologists (ASA) Physical Status Grade II
- gestational age between 37 - 42 weeks
Key exclusion criteria (5 listed)
- multiple pregnancy
- pre-eclampsia
- known fetal abnormality
- maternal cardio-respiratory comorbidity
- Body Mass Index (BMI) > 35 kg/m2.
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 |
|---|---|---|
| THRIVE pre-oxygenationClinical Trial of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Oxygen in Women having Planned Caesarean Delivery | Device | – |
Primary outcome
Number of vital capacity breaths required using THRIVE to pre-oxygenate 90% of parturients to an end tidal oxygen concentration of ≥90% (EN90). End tidal oxygen concentration >= 0.9
Time frame: 8 months study period
measure end tidal oxygen concentration through breathing system attached to anaesthetic machine
3 secondary outcomes
EN90 using THRIVE with mouth open versus mouth closed
Time frame: 8 months study period
comfort score of THRIVE
Time frame: 8 months study period
changes in fetal wellbeing during pre-oxygenation time
Time frame: 8 months study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pre-oxygenation in Term Pregnant Women, run by SABA AL-SULTTAN at 1 site in United Kingdom.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 18 Jan 2020. 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 United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of vital capacity breaths required using THRIVE to pre-oxygenate 90% of parturients to an end tidal oxygen concentration of ≥90% (EN90). End tidal oxygen concentration >= 0.9 (time frame: 8 months study period). 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 18 Jan 2020.