Anesthesia, GeneralSTAPNCT03239678
Safe Time for Apnea After Preoxygenation
A study testing 100% Oxygen, 30% Oxygen and 21% Oxygen in people with Anesthesia, General, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anesthesia, General
- What is being tested?
- 100% Oxygen, 30% Oxygen and 21% Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2017to 30 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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/㎡
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesia ,the Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655
About this study
Official title: 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.
Read the 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
- Conditions
- Anesthesia, General
- Being tested
- 100% Oxygen, 30% Oxygen, 21% Oxygen, 40% Oxygen, 60% Oxygen
- Keywords
- Preoxygenation, Oxygen Concentration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100% OxygenDrug
Also called 100% O2
Conventional preoxygenation with 100% oxygen
30% OxygenDrug
Also called 30% O2
preoxygenation with 30% oxygen
21% OxygenDrug
Also called 21% O2
preoxygenation with 21% oxygen
40% OxygenDrug
Also called 40% O2
preoxygenation with 40% oxygen
60% OxygenDrug
Also called 60% O2
preoxygenation with 60% oxygen
80% OxygenDrug
Also called 80% O2
preoxygenation with 80% oxygen
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | 100% Oxygen Receives: Drug: 100% Oxygen |
| group B | Experimental | 30% Oxygen. Receives: Drug: 30% Oxygen |
| group C | Experimental | 21% Oxygen Receives: Drug: 21% Oxygen |
| group D | Experimental | 40% Oxygen Receives: Drug: 40% Oxygen |
| group E | Experimental | 60% Oxygen Receives: Drug: 60% Oxygen |
| group F | Experimental | 80% Oxygen Receives: Drug: 80% Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safe time for apnea
Time when peripheral oxygen saturation (SpO2) is ≥ 90% after preoxygenation.
Measured: 10 min
Secondary outcomes (1)
Time needed for endotracheal intubation
Time from when the laryngoscope blade first passes the lips to when the cuff of tracheal tube is inflated.
Measured: 1 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study start1 Aug 2017
- Primary completion30 Dec 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, GeneralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zijia Li, Sixth Affiliated Hospital, Sun Yat-sen University
- Investigators
- Sanqing Jin, MD, Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen UniversityZijia Li, Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239678
- Sponsor's protocol ID
- 2017ZSLYEC-022
- Acronym
- STAP
- Status last verified
- Nov 2022
- First submitted
- 30 Jul 2017
- Last updated
- 29 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 8519574Rothen 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.
PubMed 7760608Edmark 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.
PubMed 12502975
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe Time for Apnea After Preoxygenation With Different Oxygen Concentration During the Induction of General Anesthesia
- ClinicalTrials.gov ID
- NCT03239678
- Acronym / sponsor ID
- STAP / 2017ZSLYEC-022
- Conditions
- Anesthesia, General
- Keywords
- Preoxygenation, Oxygen Concentration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 4 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Drug: 100% Oxygen100% Oxygen |
| group B | Experimental | Drug: 30% Oxygen30% Oxygen. |
| group C | Experimental | Drug: 21% Oxygen21% Oxygen |
| group D | Experimental | Drug: 40% Oxygen40% Oxygen |
| group E | Experimental | Drug: 60% Oxygen60% Oxygen |
| group F | Experimental | Drug: 80% Oxygen80% Oxygen |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 100% OxygenAlso: 100% O2Conventional preoxygenation with 100% oxygen | Drug | group A |
| 30% OxygenAlso: 30% O2preoxygenation with 30% oxygen | Drug | group B |
| 21% OxygenAlso: 21% O2preoxygenation with 21% oxygen | Drug | group C |
| 40% OxygenAlso: 40% O2preoxygenation with 40% oxygen | Drug | group D |
| 60% OxygenAlso: 60% O2preoxygenation with 60% oxygen | Drug | group E |
| 80% OxygenAlso: 80% O2preoxygenation with 80% oxygen | Drug | group F |
Primary outcome
Safe time for apnea
Time frame: 10 min
Time when peripheral oxygen saturation (SpO2) is ≥ 90% after preoxygenation.
1 secondary outcome
Time needed for endotracheal intubation
Time frame: 1 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Background: PubMed 8519574Lundquist 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.
- Background: PubMed 7760608Rothen 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.
- Background: PubMed 12502975Edmark 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanqing Jin, MD principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
Zijia Li principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 100% Oxygen, 30% Oxygen and 21% Oxygen in people with Anesthesia, General, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safe time for apnea (time frame: 10 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03239678, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.