search
Back to results

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

Primary Purpose

Chronic Anemia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
pre-oxygen
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Anemia focused on measuring anemia, non-hypoxic apnoea, tracheal intubation, anesthesia

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Fudan university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group A

Group B

Group C

Arm Description

the hemoglobin is >12g/L in patients from group A.

Hb 9-12g/L

Hb<9g/L

Outcomes

Primary Outcome Measures

duration of non-hypoxic apnoea

Secondary Outcome Measures

Full Information

First Posted
October 12, 2013
Last Updated
October 18, 2013
Sponsor
Fudan University
search

1. Study Identification

Unique Protocol Identification Number
NCT01968525
Brief Title
The Effect of Chronic Anemia on Safety Period of Tracheal Intubation in Gynecology Patients
Official Title
The Effect of Chronic Anemia on Safety Period of Tracheal Intubation in Gynecology Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Anemia
Keywords
anemia, non-hypoxic apnoea, tracheal intubation, anesthesia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
the hemoglobin is >12g/L in patients from group A.
Arm Title
Group B
Arm Type
Experimental
Arm Description
Hb 9-12g/L
Arm Title
Group C
Arm Type
Experimental
Arm Description
Hb<9g/L
Intervention Type
Biological
Intervention Name(s)
pre-oxygen
Intervention Description
3 min of preoxygenation before anesthesia induction.
Primary Outcome Measure Information:
Title
duration of non-hypoxic apnoea
Time Frame
up to 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients scheduled to undergo general anesthesia American Society of Anesthesiologists Performance Status 1-2 adults Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guiqi Geng, PhD
Organizational Affiliation
Department of anesthesiology, obstetrics and genecology hospital, FuDan university
Official's Role
Study Director
Facility Information:
Facility Name
Fudan university
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200090
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs