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

Primary Purpose

Hypoxic Brain Injury, Maternal Death

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

F Group

H Group

About this trial

This is an interventional diagnostic trial for Hypoxic Brain Injury

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Rehab Abd Elraof Abd ElazizRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

face mask group

THRIVE group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04438798

First Posted

June 17, 2020

Last Updated

August 16, 2020

Sponsor

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT04438798

Brief Title

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

Official Title

A Prospective Randomized Study of High Flow Nasal Cannula to Prevent Deoxygenation During Induction of General Anesthesia in Cesarean Section

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Unknown status

Study Start Date

July 1, 2020 (Actual)

Primary Completion Date

October 1, 2020 (Anticipated)

Study Completion Date

November 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypoxic Brain Injury, Maternal Death

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

face mask group

Arm Type

Placebo Comparator

Arm Description

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.

Arm Title

THRIVE group

Arm Type

Active Comparator

Arm Description

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

Intervention Name(s)

F Group

Other Intervention Name(s)

face mask

Intervention Description

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

Intervention Name(s)

H Group

Other Intervention Name(s)

THRIVE

Intervention Description

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.

Primary Outcome Measure Information:

Title

measure the time of safe apnea

Description

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rehab A. Abd Elaziz, Ass. Prof.

Phone

01001073703

Ext

020

trcium2002@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rehab A. Abd Elaziz, Ass.Prof.

Organizational Affiliation

Alexandria University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rehab Abd Elraof Abd Elaziz

City

Alexandria

ZIP/Postal Code

000000

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rehab A. Abd Elaziz, Ass. Prof.

Phone

01001073703

Ext

020

trcium2002@yahoo.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

28035669

Citation

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.

Results Reference

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

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