CClinicalTrials.gg
Status unknownNCT04438798Updated Aug 18, 2020

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

An interventional study of F Group and H Group in Hypoxic Brain Injury and Maternal Death, sponsored by Alexandria University. Status unknown at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-08-18.

Sponsored by Alexandria University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
01

Study 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 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%.

02

Conditions studied

  • Hypoxic Brain Injury
  • Maternal Death
03

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (estimated)

Study arms

  • Placebo comparator
    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.

    Other: F Group

  • Active comparator
    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.

    Other: H Group

Interventions

  • OtherF 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.

    Also known as: face mask

  • OtherH 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.

    Also known as: THRIVE

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 10 minutes after induction

06

Study locations

1 of 1 sites recruiting
  • Rehab Abd Elraof Abd Elaziz
    Alexandria, 000000, Egypt
    Recruiting
07

References and documents

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 ↗
08

Registry details

Key details

Study ID
NCT04438798
Lead sponsor
Alexandria University
Responsible party
rehab zayed (Assisstant Professor of Anesthesia, Alexandria University) — Principal investigator
First posted
Jun 19, 2020
Start date
Jul 1, 2020
Primary completion
Oct 1, 2020 (estimated)
Completion
Nov 1, 2020 (estimated)
Last update
Aug 18, 2020

Study contacts

Rehab A. Abd Elaziz, Ass. Prof.
Contact
trcium2002@yahoo.com
01001073703 ext. 020
Rehab A. Abd Elaziz, Ass.Prof.
principal investigator · Alexandria University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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