CClinicalTrials.gg
Status unknownNCT03392818Updated Jan 9, 2018

An Innovative Approach for Uniblocker Intubation

An interventional study of The measured distance and formula in Therapeutic Procedural Complication, sponsored by The First Hospital of Qinhuangdao. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-01-09.

Sponsored by The First Hospital of Qinhuangdao · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

To measure the distance between the upper edge of the thyroid cartilage to the upper edge of the sternum add the distance from the upper edge of the sternum to the carina was calculated according to the chest CT scans as a guide to the placement of Uniblocker without the aid of FOB.

Read the detailed description

In previous study, the investigators found Chest computed tomography (CT) image can accurately predicting the optimal insertion depth of Uniblocker,however in some hospital the CT scan performed for the preoperative surgical evaluation without the vocal cords slices. If a more extensive CT scan was needed for obtaining a more reliable image of the vocal cords,the additional exposure dose would be a major disadvantage of the method.So the investigators measure the distance between the upper edge of the thyroid cartilage to the upper edge of the sternum add the distance from the upper edge of the sternum to the carina calculated according to the chest CT scans as a guide to the placement of Uniblocker without the aid of FOB.

02

Conditions studied

  • Therapeutic Procedural Complication
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Adult patients undergoing left side thoracic surgery
  2. The thoracic surgery requiring a Uniblocker for one-lung ventilation

Exclusion criteria

Exclusion Criteria:

  1. Age>70 or \<18 years
  2. ASA classifications >III
  3. BMI >35kg/m2
  4. Modified Mallampati classification ≥III
  5. Thoracic surgery within the last one month
  6. Severe cardiopulmonary disease
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    formula

    Calculate the depth of intubation according to the formula of 0.1977\* patient's height - 4.2423

    Other: formula

  • Experimental
    Fiberoptic bronchoscope

    intubation of Uniblocker under the Under the guidance of Fiberoptic bronchoscope

    Device: Fiberoptic bronchoscope

  • Experimental
    The measured distance

    To measure the distance between the upper edge of the thyroid cartilage to the upper edge of the sternum add the distance from the upper edge of the sternum to the carina calculated according to the chest CT scans as a guide to the placement of Uniblocker without the aid of FOB.

    Other: The measured distance

Interventions

  • OtherThe measured distance

    To measure the distance between the upper edge of the thyroid cartilage to the upper edge of the sternum add the distance from the upper edge of the sternum to the carina calculated according to the chest CT scans as a guide to the placement of Uniblocker without the aid of Fiberoptic bronchoscope.

  • Otherformula

    Calculate the depth of intubation according to the formula of 0.1977\* patient's height - 4.2423

  • DeviceFiberoptic bronchoscope

    The intubation of Uniblocker under the guidance of Fiberoptic bronchoscope

05

What researchers measure

Primary outcomes

  1. The intubation time

    The intubation time defined as the time from the anesthesiologist inserted the video laryngoscope between the teeth of patients until Uniblocker at the optimal position and this was done using a stopwatch.

    Time frame: 1 year

06

Study locations

1 of 1 sites recruiting
  • The first hospital of Qinhuangdao
    Qinhuangdao, Hebei 066000, China
    Recruiting
07

Registry details

Key details

Study ID
NCT03392818
Lead sponsor
The First Hospital of Qinhuangdao
Responsible party
Sponsor
First posted
Jan 8, 2018
Start date
Jan 7, 2018
Primary completion
May 2018 (estimated)
Completion
Jun 2018 (estimated)
Last update
Jan 9, 2018

Study contacts

Yang Li
Contact
+86-03355908500
Ximing Qi
Contact
ximingqi123@sina.com
+8631187027951
Ximing Qi
study director · The First Hospital of Qinhuangdao

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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