High Flow Nasal Cannula to Prevent Deoxygenation During Induction of General Anesthesia in Cesarean Section

NCT ID: NCT04438798

Last Updated: 2020-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2020-11-01

Brief Summary

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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

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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

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Hypoxic Brain Injury Maternal Death

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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face mask group

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.

Group Type PLACEBO_COMPARATOR

F Group

Intervention Type OTHER

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.

THRIVE group

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.

Group Type ACTIVE_COMPARATOR

H Group

Intervention Type OTHER

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.

Interventions

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F Group

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.

Intervention Type OTHER

H Group

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.

Intervention Type OTHER

Other Intervention Names

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face mask THRIVE

Eligibility Criteria

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Inclusion Criteria

* pregnant females
* Of American Society of Anesthesiologists (ASA) physical Status I and II
* For elective cesarean section under general anesthesia

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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rehab zayed

Assisstant Professor of Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rehab A. Abd Elaziz, Ass.Prof.

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Locations

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Rehab Abd Elraof Abd Elaziz

Alexandria, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Rehab A. Abd Elaziz, Ass. Prof.

Role: CONTACT

01001073703 ext. 020

Facility Contacts

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Rehab A. Abd Elaziz, Ass. Prof.

Role: primary

01001073703 ext. 020

References

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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.

Reference Type BACKGROUND
PMID: 28035669 (View on PubMed)

Other Identifiers

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0304665

Identifier Type: -

Identifier Source: org_study_id

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