Safe Time for Apnea After Preoxygenation

Anesthesia, General Clinical Trial

— STAP  

Official title:

Safe Time for Apnea After Preoxygenation With Different Oxygen Concentration During the Induction of General Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03239678
• Other study ID #: 2017ZSLYEC-022
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: December 30, 2017

Study information

• Verified date: November 2022
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The use of 100% oxygen during the induction of general anesthesia is always preferable to have enough time to secure the airway by endotracheal intubation, because preoxygenation with a low oxygen concentration may reduce the safe time for apnea. However, using a low oxygen concentration during preoxygenation might prevent the formation of atelectasis. There is still no clear conclusion about the best oxygen concentration for preoxygenation. Our study is designed to evaluate the safety of preoxygenation with 80%, 60%, 40%, 30% and 21% oxygen by the safe time for apnea during the induction of general anesthesia.

Description:

We decide to add 3 groups (80%, 60%, and 40% oxygen) in our study to fully evaluate the safety of preoxygenation with different oxygen concentration.

Zijia Li 2018.3.2

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 30, 2017
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Nonsmoking patients aged 18 years to 60 years

• Undergoing general anesthesia for elective surgery

• Pulse oxygen saturation =95% when breathing air quietly in bed

• American Society of Anesthesiologists(ASA) physical status class I-II

• Informed consent can be obtained

Exclusion Criteria:

• A suspected difficult airway

• Be allergic to midazolam, propofol , fentanyl or Cisatracurium

• Severe disease of respiratory system or cardiovascular system,or obstruction of the digestive tract

• Oxygen reserve is suspected low,or patient who does not tolerate hypoxemia well

• A history of mental disorder or patient who can not collaborate well

• Body mass index more than 30 kg/?

Related Conditions & MeSH terms

• Anesthesia, General

Intervention

Drug:
• 100% Oxygen
Conventional preoxygenation with 100% oxygen
• 30% Oxygen
preoxygenation with 30% oxygen
• 21% Oxygen
preoxygenation with 21% oxygen
• 40% Oxygen
preoxygenation with 40% oxygen
• 60% Oxygen
preoxygenation with 60% oxygen
• 80% Oxygen
preoxygenation with 80% oxygen

Locations

Country	Name	City	State
China	Department of Anesthesia ,the Sixth Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (3)

Edmark L, Kostova-Aherdan K, Enlund M, Hedenstierna G. Optimal oxygen concentration during induction of general anesthesia. Anesthesiology. 2003 Jan;98(1):28-33. doi: 10.1097/00000542-200301000-00008. — View Citation

Lundquist H, Hedenstierna G, Strandberg A, Tokics L, Brismar B. CT-assessment of dependent lung densities in man during general anaesthesia. Acta Radiol. 1995 Nov;36(6):626-32. — View Citation

Rothen HU, Sporre B, Engberg G, Wegenius G, Reber A, Hedenstierna G. Prevention of atelectasis during general anaesthesia. Lancet. 1995 Jun 3;345(8962):1387-91. doi: 10.1016/s0140-6736(95)92595-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safe time for apnea	Time when peripheral oxygen saturation (SpO2) is = 90% after preoxygenation.	10 min
Secondary	Time needed for endotracheal intubation	Time from when the laryngoscope blade first passes the lips to when the cuff of tracheal tube is inflated.	1 min