NCT01968525

Brief Summary

  1. 1.Every individual receiving a general anesthetic is at potential risk for developing a ''cannot intubate-cannot ventilate'' situation following anesthetic induction.
  2. 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. 3.The main physiological functions of red blood cell hemoglobin are to deliver oxygen to the peripheral tissues.
  4. 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. 5.Previous studies about the duration of non-hypoxic apnoea focus on methods to improve the safety period of tracheal intubation.
  6. 6.To our knowledge, there is no literature about the duration of non-hypoxic apnoea of anemia patients.
  7. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 12, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 24, 2013

Completed
Last Updated

October 24, 2013

Status Verified

October 1, 2013

Enrollment Period

5 months

First QC Date

October 12, 2013

Last Update Submit

October 18, 2013

Conditions

Keywords

anemianon-hypoxic apnoeatracheal intubationanesthesia

Outcome Measures

Primary Outcomes (1)

  • duration of non-hypoxic apnoea

    up to 6 months

Study Arms (3)

Group A

EXPERIMENTAL

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

Biological: pre-oxygen

Group B

EXPERIMENTAL

Hb 9-12g/L

Biological: pre-oxygen

Group C

EXPERIMENTAL

Hb\<9g/L

Biological: pre-oxygen

Interventions

pre-oxygenBIOLOGICAL

3 min of preoxygenation before anesthesia induction.

Group AGroup BGroup C

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients scheduled to undergo general anesthesia
  • American Society of Anesthesiologists Performance Status 1-2
  • adults

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan university

Shanghai, Shanghai Municipality, 200090, China

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Guiqi Geng, PhD

    Department of anesthesiology, obstetrics and genecology hospital, FuDan university

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 12, 2013

First Posted

October 24, 2013

Study Start

April 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

October 24, 2013

Record last verified: 2013-10

Locations