Hypoxic Brain InjuryNCT04438798
High Flow Nasal Cannula to Prevent Deoxygenation During Induction of General Anesthesia in Cesarean Section
A study testing F Group and H Group in people with Hypoxic Brain Injury and Maternal Death, run by Alexandria University at 1 site in Egypt.
Trial summary
Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) using high flow oxygen therapy for preoxygenation and oxygen supplementation during apnoea has shown promising results Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Hypoxic Brain Injury, Maternal Death
- What is being tested?
- F Group and H Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2020to 1 Nov 2020
- Phase
- Interventional
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnant females
- Of American Society of Anesthesiologists (ASA) physical Status I and II
- For elective cesarean section under general anesthesia
Who cannot join
- with room air saturation of <98%
- anticipated difficult airway
- anticipated obstetric risk factor or precious baby
- chronic obstructive pulmonary disease
- thyrotoxicosis
- pheochromocytoma
- hyperkalaemia
- significant cardiac illness
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Rehab Abd Elraof Abd Elaziz
Alexandria, 000000
Rehab A. Abd Elaziz, Ass. Prof., 01001073703 ext. 020, trcium2002@yahoo.com
About this study
Official title: A Prospective Randomized Study of High Flow Nasal Cannula to Prevent Deoxygenation During Induction of General Anesthesia in Cesarean Section
Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) using high flow oxygen therapy for preoxygenation and oxygen supplementation during apnoea has shown promising results
Read the detailed description
Eeffective preoxygenation followed by apnoeic oxygenation enables anaesthesiologists to safely prolong the apnoea time which is the time (seconds) of apnea following preoxygenation and muscle relaxation before to peripheral oxygen saturations (SpO2) decreases by 2%.
- Conditions
- Hypoxic Brain Injury, Maternal Death
- Being tested
- F Group, H Group
- Medical subject headings
- Hypoxia, Brain, Maternal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F GroupOther
Also called face mask
In Group F, pregnant females will be preoxygenated with 100% oxygen using a tight-fitting face mask at a rate of 6 L/min for 3 min with end-tidal gas monitoring.
H GroupOther
Also called THRIVE
In Group H, high-flow humidified oxygen warmed to 37°C will be delivered through nasal cannula at the rate of 30 L/ min for 30 seconds then 50 liters per minute for a further 150 seconds.
| Study group | Role | What they receive |
|---|---|---|
| face mask group | Placebo comparator | Pregnant females will be preoxygenated with 100% oxygen using a tight-fitting face mask at a rate of 6 L/min for 3 min with end-tidal gas monitoring. Receives: Other: F Group |
| THRIVE group | Active comparator | High-flow humidified oxygen warmed to 37°C will be delivered through nasal cannula at the rate of 30 L/ min for 30 seconds then 50 liters per minute for a further 150 seconds. Receives: Other: H Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure the time of safe apnea
The apnea time will start from the onset of cessation of breathing as evidenced by a flat line in the capnogram with the absence of chest movements
Measured: 10 minutes after induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start1 Jul 2020
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypoxic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rehab zayed, Alexandria University
- Investigators
- Rehab A. Abd Elaziz, Ass.Prof., Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438798
- Sponsor's protocol ID
- 0304665
- Status last verified
- Aug 2020
- First submitted
- 17 Jun 2020
- Last updated
- 18 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mir F, Patel A, Iqbal R, Cecconi M, Nouraei SA. A randomised controlled trial comparing transnasal humidified rapid insufflation ventilatory exchange (THRIVE) pre-oxygenation with facemask pre-oxygenation in patients undergoing rapid sequence induction of anaesthesia. Anaesthesia. 2017 Apr;72(4):439-443. doi: 10.1111/anae.13799. Epub 2016 Dec 30.
PubMed 28035669
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study of High Flow Nasal Cannula to Prevent Deoxygenation During Induction of General Anesthesia in Cesarean Section
- ClinicalTrials.gov ID
- NCT04438798
- Acronym / sponsor ID
- 0304665
- Conditions
- Hypoxic Brain Injury, Maternal Death
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 19 Jun 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.
Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) using high flow oxygen therapy for preoxygenation and oxygen supplementation during apnoea has shown promising results
Detailed description
Eeffective preoxygenation followed by apnoeic oxygenation enables anaesthesiologists to safely prolong the apnoea time which is the time (seconds) of apnea following preoxygenation and muscle relaxation before to peripheral oxygen saturations (SpO2) decreases by 2%.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| face mask group | Placebo comparator | Other: F GroupPregnant females will be preoxygenated with 100% oxygen using a tight-fitting face mask at a rate of 6 L/min for 3 min with end-tidal gas monitoring. |
| THRIVE group | Active comparator | Other: H GroupHigh-flow humidified oxygen warmed to 37°C will be delivered through nasal cannula at the rate of 30 L/ min for 30 seconds then 50 liters per minute for a further 150 seconds. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- pregnant females
- Of American Society of Anesthesiologists (ASA) physical Status I and II
- For elective cesarean section under general anesthesia
Key exclusion criteria (8 listed)
- with room air saturation of <98%
- anticipated difficult airway
- anticipated obstetric risk factor or precious baby
- chronic obstructive pulmonary disease
- thyrotoxicosis
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 |
|---|---|---|
| F GroupAlso: face maskIn Group F, pregnant females will be preoxygenated with 100% oxygen using a tight-fitting face mask at a rate of 6 L/min for 3 min with end-tidal gas monitoring. | Other | face mask group |
| H GroupAlso: THRIVEIn Group H, high-flow humidified oxygen warmed to 37°C will be delivered through nasal cannula at the rate of 30 L/ min for 30 seconds then 50 liters per minute for a further 150 seconds. | Other | THRIVE group |
Primary outcome
measure the time of safe apnea
Time frame: 10 minutes after induction
The apnea time will start from the onset of cessation of breathing as evidenced by a flat line in the capnogram with the absence of chest movements
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Background: PubMed 28035669Mir F, Patel A, Iqbal R, Cecconi M, Nouraei SA. A randomised controlled trial comparing transnasal humidified rapid insufflation ventilatory exchange (THRIVE) pre-oxygenation with facemask pre-oxygenation in patients undergoing rapid sequence induction of anaesthesia. Anaesthesia. 2017 Apr;72(4):439-443. doi: 10.1111/anae.13799. Epub 2016 Dec 30.
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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.
Rehab A. Abd Elaziz, Ass.Prof. principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing F Group and H Group in people with Hypoxic Brain Injury and Maternal Death, run by Alexandria University at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 18 Aug 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rehab A. Abd Elaziz, Ass. Prof. (01001073703 ext. 020, trcium2002@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure the time of safe apnea (time frame: 10 minutes after induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04438798, which also lists 1 linked publication.
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 Aug 2020.