Safe Time for Apnea After Preoxygenation (STAP)

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, General
• Intervention / Treatment: Drug: 100% Oxygen; Drug: 30% Oxygen; Drug: 21% Oxygen; Drug: 40% Oxygen; Drug: 60% Oxygen; Drug: 80% Oxygen

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510655
      • Department of Anesthesia ,the Sixth Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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/㎡

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: group A; 100% Oxygen	Drug: 100% Oxygen; Conventional preoxygenation with 100% oxygen; Other Names: 100% O2
EXPERIMENTAL: group B; 30% Oxygen.	Drug: 30% Oxygen; preoxygenation with 30% oxygen; Other Names: 30% O2
EXPERIMENTAL: group C; 21% Oxygen	Drug: 21% Oxygen; preoxygenation with 21% oxygen; Other Names: 21% O2
EXPERIMENTAL: group D; 40% Oxygen	Drug: 40% Oxygen; preoxygenation with 40% oxygen; Other Names: 40% O2
EXPERIMENTAL: group E; 60% Oxygen	Drug: 60% Oxygen; preoxygenation with 60% oxygen; Other Names: 60% O2
EXPERIMENTAL: group F; 80% Oxygen	Drug: 80% Oxygen; preoxygenation with 80% oxygen; Other Names: 80% O2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safe time for apnea	Time when peripheral oxygen saturation (SpO2) is ≥ 90% after preoxygenation.	10 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
• Investigators: Principal Investigator: Zijia Li, Sixth Affiliated Hospital, Sun Yat-sen University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2017
• Primary Completion (ACTUAL): December 30, 2017
• Study Completion (ACTUAL): December 30, 2017

Study Registration Dates

• First Submitted: July 30, 2017
• First Submitted That Met QC Criteria: August 2, 2017
• First Posted (ACTUAL): August 4, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Preoxygenation; Oxygen Concentration
• Other Study ID Numbers: 2017ZSLYEC-022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No