The Effect of Chronic Anemia on Safety Period of Tracheal Intubation in Gynecology Patients

Chronic Anemia Clinical Trial

Official title:

The Effect of Chronic Anemia on Safety Period of Tracheal Intubation in Gynecology Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01968525
• Other study ID #: 199987
• Status: Completed
• Phase: N/A
• First received: October 12, 2013
• Last updated: October 18, 2013
• Start date: April 2013
• Est. completion date: September 2013

Study information

• Verified date: October 2013
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical 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 unanticipated difficult airway.

3. The main physiological functions of red blood cell hemoglobin are to deliver oxygen to the peripheral tissues.

4. During anemia, a reduction in blood oxygen content occurs as a result of reduced Hb while arterial oxygenation and oxyhemoglobin saturation remain high.

5. Previous studies about the duration of non-hypoxic apnoea focus on methods to improve the safety period of tracheal intubation.

6. To our knowledge, there is no literature about the duration of non-hypoxic apnoea of anemia patients.

7. The aim of this study was to assess the effect of chronic anemia on the duration of non-hypoxic apnoea during induction of anaesthesia.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. patients scheduled to undergo general anesthesia

2. American Society of Anesthesiologists Performance Status 1-2

3. adults

Exclusion Criteria:

1. Individuals with significant cardiorespiratory or cerebrovascular disease,

2. difficult intubation

3. history of epilepsy

4. body mass index >25 kg/m2,

5. and those who had smoking history in past 6 months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Anemia
• Chronic Anemia

Intervention

Biological:
• pre-oxygen
3 min of preoxygenation before anesthesia induction.

Locations

Country	Name	City	State
China	Fudan university	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of non-hypoxic apnoea		up to 6 months	Yes