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

• Sponsor: Fudan University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01968525
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arms: 3
• Duration (Months): 5
• Patients Per Site Per Month: 9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Anemia	Biological: pre-oxygen	N/A

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

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: The Effect of Chronic Anemia on Safety Period of Tracheal Intubation in Gynecology Patients
• Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A the hemoglobin is >12g/L in patients from group A.	Biological: pre-oxygen; 3 min of preoxygenation before anesthesia induction.
Experimental: Group B Hb 9-12g/L	Biological: pre-oxygen; 3 min of preoxygenation before anesthesia induction.
Experimental: Group C Hb<9g/L	Biological: pre-oxygen; 3 min of preoxygenation before anesthesia induction.

Outcome Measures

Primary Outcome Measures

1. duration of non-hypoxic apnoea [up to 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fudan university	Shanghai	Shanghai	China	200090

Sponsors and Collaborators

• Fudan University

Investigators

• Study Director: Guiqi Geng, PhD, Department of anesthesiology, obstetrics and genecology hospital, FuDan university

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Geng guiqi, PhD, Fudan University
• ClinicalTrials.gov Identifier: NCT01968525
• Other Study ID Numbers: 199987
• First Posted: Oct 24, 2013
• Last Update Posted: Oct 24, 2013
• Last Verified: Oct 1, 2013

• Keywords provided by Geng guiqi, PhD, Fudan University: anemia; non-hypoxic apnoea; tracheal intubation; anesthesia
• Additional relevant MeSH terms: Anemia

Study Results

No Results Posted as of Oct 24, 2013