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

Maternal Death Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04438798
• Other study ID #: 0304665
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: November 1, 2020

Study information

• Verified date: August 2020
• Source: Alexandria University
• Contact: Rehab A. Abd Elaziz, Ass. Prof.
• Phone: 01001073703
• Email: trcium2002[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Hypoxic Brain Injury
• Maternal Death

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Egypt	Rehab Abd Elraof Abd Elaziz	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	10 minutes after induction