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Evaluation of the quality of ventilation by the mask in three techniques: E-C, Thenar Eminence and X

Protocol summary

Study aim
Evaluation of ventilation quality by mask in three techniques E-C, Thenar Eminence and X
Design
Clinical trial, with parallel group, Not blinded, non randomized, on 310 patients.
Settings and conduct
All patients referred to the emergency department of Imam Reza Hospital, and who need an airway management, after obtaining the consent of the patient's guardian (considering that some patients referred to the emergency department are not in a position to obtain consent from them due to their clinical condition , Respiratory distress, etc. is not possible. After, pre-oxygenation, pre-medication and induction of anesthesia, patients are ventilated by a bag and mask attached to a capnogram by an emergency medicine specialist, senior resident. RESPIRONICS brand is used, depending on whether patients are in group I, II or III, after induction of anesthesia, it is ventilated 8 times by Bag and Mask, and at the end of each ventilation, ETCO2 is recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients need a reliable airway that is indicated for fast-sequence intubation. Exclusion criteria: Patients who should be intubated by crash or awake method, as well as obese people, patients who have nasopharyngeal tube, patients with facial abnormalities, history of MALIGNANT HYPERTHERMIA, burns more than ten percent grade 3, peritonitis more than Three days, and Patients that have a long beard and mustache.
Intervention groups
Patients in need of reliable airway that are indicated for intubation in rapid sequence
Main outcome variables
The X method is easy to use for doctors with small hands and is a long-term use without fatigue and finger pain. If the quality of ventilation in X method is better than E-C and Thenar Eminence methods, it can be recommended, and the X method is a new method.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20121010011067N5
Registration date: 2021-07-17, 1400/04/26
Registration timing: prospective

Last update: 2021-07-17, 1400/04/26
Update count: 0
Registration date
2021-07-17, 1400/04/26
Registrant information
Name
Mahboub Pouraghaei
Name of organization / entity
Tabriz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 2078
Email address
pouraghaeim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-06, 1400/05/15
Expected recruitment end date
2022-02-04, 1400/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the quality of ventilation by the mask in three techniques: E-C, Thenar Eminence and X
Public title
Evaluation of the quality of ventilation by the mask in three techniques: E-C, Thenar Eminence and X
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who need airway management and intubation that they need intubation with rapid sequence intubation
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 310
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, participants will be unaware of the allocation of study groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Imam Reza Hospital, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5356136883
Approval date
2020-07-13, 1399/04/23
Ethics committee reference number
IR.TBZMED.REC.1399.383

Health conditions studied

1

Description of health condition studied
Patients need airway
ICD-10 code
T88.4
ICD-10 code description
Failed or difficult intubation

Primary outcomes

1

Description
Opening the airway
Timepoint
Patients that need airway, after induction of anesthesia, are ventilated 8 times by Bag and Mask.
Method of measurement
After induction of anesthesia, patients are ventilated 8 times by Bag and Mask and at the end of each ventilation, ETCO2 is recorded.

Secondary outcomes

empty

Intervention groups

1

Description
Group 1: Patients who are ventilated by the E-C technique in which the first and second fingers of the resuscitator in the form of the letter C surround the mask pad and the next three fingers in the form of the letter E, surround the lower jaw (mandible). The RESPIRONICS brand capnogram device and the product of Respironics, Inc. with the specifications of Cosmas Court 2271 and Carlsbad, CA USA 92009 will be used.
Category
Treatment - Devices

2

Description
Group 2: Patients who are ventilated using the Thenar Eminence technique, in which the tenar muscles and the first finger of the resuscitator surround the mask pad and the next four fingers of the lower jaw.
Category
Treatment - Devices

3

Description
Group 3: Patients who are ventilated using the X-technique, in which the palm of the resuscitator rests on the front of the pillow and her fingers guide the patient up to the chin
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mahboub pouraghaei
Street address
Imam Reza Hospital, Tabriz University of Medical Sciences, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5356136883
Phone
+98 41 3335 2078
Email
pouraghaeim@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahboub Pouraghaei
Street address
Tabriz
City
Imam Reza Hospital, Tabriz University of Medical Sciences, Golgasht St
Province
East Azarbaijan
Postal code
5356136883
Phone
+98 41 3335 2078
Email
pouraghaeim@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahboub Pouraghaei
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Imam Reza Hospital, Tabriz University of Medical Sciences, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5356136883
Phone
+98 41 3335 2078
Email
pouraghaeim@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahboub Pouraghaei
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Imam Reza Hospital, Tabriz University of Medical Sciences, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5356136883
Phone
+98 41 3335 2078
Email
pouraghaeim@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahboub Pouraghaei
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Imam Reza Hospital, Tabriz University of Medical Sciences, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5356136883
Phone
+98 41 3335 2078
Email
pouraghaeim@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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