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Safe Time for Apnea After Preoxygenation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03239678
Acronym
STAP
Enrollment
90
Registered
2017-08-04
Start date
2017-08-01
Completion date
2017-12-30
Last updated
2022-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, General

Keywords

Preoxygenation, Oxygen Concentration

Brief 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.

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

Interventions

Conventional preoxygenation with 100% oxygen

preoxygenation with 30% oxygen

preoxygenation with 21% oxygen

preoxygenation with 40% oxygen

preoxygenation with 60% oxygen

preoxygenation with 80% oxygen

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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/㎡

Design outcomes

Primary

MeasureTime frameDescription
Safe time for apnea10 minTime when peripheral oxygen saturation (SpO2) is ≥ 90% after preoxygenation.

Secondary

MeasureTime frameDescription
Time needed for endotracheal intubation1 minTime from when the laryngoscope blade first passes the lips to when the cuff of tracheal tube is inflated.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026