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

October 18, 2013 updated by: Geng guiqi, Fudan University
  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200090
        • Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
duration of non-hypoxic apnoea
Time Frame: up to 6 months
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

October 12, 2013

First Submitted That Met QC Criteria

October 18, 2013

First Posted (Estimate)

October 24, 2013

Study Record Updates

Last Update Posted (Estimate)

October 24, 2013

Last Update Submitted That Met QC Criteria

October 18, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 199987

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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