Chronic AnemiaNCT01968525
The Effect of Chronic Anemia on Safety Period of Tracheal Intubation in Gynecology Patients
A study testing pre-oxygen in people with Chronic Anemia, run by Fudan University at 1 site in China.
Trial summary
1. Every individual receiving a general anesthetic is at potential risk for developing a ''cannot intubate-cannot ventilate'' situation following anesthetic induction. 2. Building up of oxygen reserves assumes great significance as this provides a longer duration of non-hypoxic apnea should one be faced with an… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Chronic Anemia
- What is being tested?
- pre-oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- Apr 2013to Sep 2013
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- patients scheduled to undergo general anesthesia
- American Society of Anesthesiologists Performance Status 1-2
- adults
Who cannot join
- Individuals with significant cardiorespiratory or cerebrovascular disease,
- difficult intubation
- history of epilepsy
- body mass index >25 kg/m2,
- and those who had smoking history in past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
- Every individual receiving a general anesthetic is at potential risk for developing a ''cannot intubate-cannot ventilate'' situation following anesthetic induction.
- Building up of oxygen reserves assumes great significance as this provides a longer duration of non-hypoxic apnea should one be faced with an unanticipated difficult airway.
- The main physiological functions of red blood cell hemoglobin are to deliver oxygen to the peripheral tissues.
- During anemia, a reduction in blood oxygen content occurs as a result of reduced Hb while arterial oxygenation and oxyhemoglobin saturation remain high.
- Previous studies about the duration of non-hypoxic apnoea focus on methods to improve the safety period of tracheal intubation.
- To our knowledge, there is no literature about the duration of non-hypoxic apnoea of anemia patients.
- The aim of this study was to assess the effect of chronic anemia on the duration of non-hypoxic apnoea during induction of anaesthesia.
Read the detailed description
After breathing for 3 minutes, anesthesia induction was conducted. The endotracheal tube position was confirmed after anesthesia induction. Patients were left apneic with the endotracheal tube open to room air. The non-hypoxic apneic period was recorded as the time (in seconds) taken for the drop in pulse saturation to 90% or an apneic period of 10 min elapsed, whichever was earlier.
- Conditions
- Chronic Anemia
- Being tested
- pre-oxygen
- Keywords
- anemia, non-hypoxic apnoea, tracheal intubation, anesthesia
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre-oxygenBiological
3 min of preoxygenation before anesthesia induction.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | the hemoglobin is >12g/L in patients from group A. Receives: Biological: pre-oxygen |
| Group B | Experimental | Hb 9-12g/L Receives: Biological: pre-oxygen |
| Group C | Experimental | Hb<9g/L Receives: Biological: pre-oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of non-hypoxic apnoea
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2013 (estimated)
- Study startApr 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic AnemiaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geng guiqi, Fudan University
- Investigators
- Guiqi Geng, PhD, Study director, Department of anesthesiology, obstetrics and genecology hospital, FuDan university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968525
- Sponsor's protocol ID
- 199987
- Status last verified
- Oct 2013
- First submitted
- 12 Oct 2013
- Last updated
- 24 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chronic Anemia on Safety Period of Tracheal Intubation in Gynecology Patients
- ClinicalTrials.gov ID
- NCT01968525
- Acronym / sponsor ID
- 199987
- Conditions
- Chronic Anemia
- Keywords
- anemia, non-hypoxic apnoea, tracheal intubation, anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 24 Oct 2013 (estimated)
- 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.
- Every individual receiving a general anesthetic is at potential risk for developing a ''cannot intubate-cannot ventilate'' situation following anesthetic induction.
- Building up of oxygen reserves assumes great significance as this provides a longer duration of non-hypoxic apnea should one be faced with an unanticipated difficult airway.
- The main physiological functions of red blood cell hemoglobin are to deliver oxygen to the peripheral tissues.
- During anemia, a reduction in blood oxygen content occurs as a result of reduced Hb while arterial oxygenation and oxyhemoglobin saturation remain high.
- Previous studies about the duration of non-hypoxic apnoea focus on methods to improve the safety period of tracheal intubation.
- To our knowledge, there is no literature about the duration of non-hypoxic apnoea of anemia patients.
- The aim of this study was to assess the effect of chronic anemia on the duration of non-hypoxic apnoea during induction of anaesthesia.
Detailed description
After breathing for 3 minutes, anesthesia induction was conducted. The endotracheal tube position was confirmed after anesthesia induction. Patients were left apneic with the endotracheal tube open to room air. The non-hypoxic apneic period was recorded as the time (in seconds) taken for the drop in pulse saturation to 90% or an apneic period of 10 min elapsed, whichever was earlier.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: pre-oxygenthe hemoglobin is >12g/L in patients from group A. |
| Group B | Experimental | Biological: pre-oxygenHb 9-12g/L |
| Group C | Experimental | Biological: pre-oxygenHb<9g/L |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients scheduled to undergo general anesthesia
- American Society of Anesthesiologists Performance Status 1-2
- adults
Key exclusion criteria (5 listed)
- Individuals with significant cardiorespiratory or cerebrovascular disease,
- difficult intubation
- history of epilepsy
- body mass index >25 kg/m2,
- and those who had smoking history in past 6 months
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 |
|---|---|---|
| pre-oxygen3 min of preoxygenation before anesthesia induction. | Biological | Group A, Group B, Group C |
Primary outcome
duration of non-hypoxic apnoea
Time frame: up to 6 months
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 24 Oct 2013.
Related trials for Chronic Anemia
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
RecruitingPhase 2
Personalized NK Cell Therapy in CBT
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Biphenotypic Leukemia
Not yet recruiting
Focused Ultrasound Neuromodulation for Chronic Pain
Chronic Pain, Sickle Cell Disease
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
RecruitingObservational study
Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
Hairy Cell Leukemia (HCL), Chronic Lymphocytic Leukemia (CLL)
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.
Guiqi Geng, PhD study director
Department of anesthesiology, obstetrics and genecology hospital, FuDan 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 pre-oxygen in people with Chronic Anemia, run by Fudan 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 3 inclusion and 5 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 24 Oct 2013. 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?
duration of non-hypoxic apnoea (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Oct 2013.