Evaluation of palmar pressure test accuracy to confirm proper placement of the endotracheal tube in patients undergoing elective surgery under general anesthesia
Determine the accuracy of the palm pressure test at the correct location of the tracheal tube
Design
This study is a single group clinical trial. The intervention group includes the application of palmar pressure, this test is done by placing on the right side of the patient and applying the pressure on the fifth interdimensional midway of the squamous area of the patient's right chest and confirming the flow of air from the tracheal tube by a plastic gloves attached to the end of the endotracheal tube.
Settings and conduct
This study is done at Imam Khomeini Hospital, Tehran.
70 patients underwent elective surgery with general anesthesia in one group. Intervention was applying palmar pressure in the confirmation of the correct site of the tracheal tube.
Participants/Inclusion and exclusion criteria
Inclusion criteria: ASA Class I and II; Malampati I; Elective patients; Without any anatomical deformity in the chest.
Non-inclusion criteria: Pregnancy; emergency surgeries; suspected airway problems; patients with joint pain; osteoarthritis; heavy breast; BMI >30; asthma; a congenital deformity in chest structure; ischemic patients.
Intervention groups
Some compression equal to 3 kg is placed by hand palm in the area below the left nipple in the T5-T6 space, and the pressure importer is simultaneously controlling the air coming out of the tracheal tube with a small balloon that attached to the end of the tracheal tube.
Main outcome variables
The correct location of the tracheal intubation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170709034978N2
Registration date:2019-04-25, 1398/02/05
Registration timing:retrospective
Last update:2019-04-25, 1398/02/05
Update count:0
Registration date
2019-04-25, 1398/02/05
Registrant information
Name
Mojgan Rahimi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 84426391
Email address
mrahimi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
2018-02-20, 1396/12/01
Actual recruitment end date
2018-05-22, 1397/03/01
Trial completion date
2018-05-22, 1397/03/01
Scientific title
Evaluation of palmar pressure test accuracy to confirm proper placement of the endotracheal tube in patients undergoing elective surgery under general anesthesia
Public title
Palmar pressure test accuracy to confirm proper placement of the endotracheal tube
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
ASA Class I and II
Malampati I
Elective patients
NPO for 8 hours or more
without any anatomical deformity in the chest
Exclusion criteria:
Pregnancy
emergency surgeries
suspected airway problems
patients with joint pain
osteoarthritis
heavy breast (in the supine position behind the breast on T5-T6 space)
BMI >30
COPD
asthma
congenital deformity in chest structure
ischemic patients
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
70
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
The study type is test evaluation
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Imam Khomeini hospital(rah)
Street address
Keshavarz blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2018-02-20, 1396/12/01
Ethics committee reference number
IR.TUMS.IKHC.REC.1396.4565
Health conditions studied
1
Description of health condition studied
Palmar pressure test accuracy to confirm proper placement of the endotracheal tube
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
determination true or false intubation
Timepoint
Immediately after palm pressure
Method of measurement
Putting the balloon at the end of the tracheal tube and evaluating the air exiting
Secondary outcomes
1
Description
Timepoint
Method of measurement
Intervention groups
1
Description
Intervention group: Applying palm pressure, This test is placed on the right side of the patient and pressure on the interstitial space of the fifth midline of the dialectal right side of the chest of the patient and confirmation of the flow of air from the tracheal tube through the use of a plastic glove attached to the end of the tracheal tube.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini copmlex hospital
Full name of responsible person
Mojgan Rahimi
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2620
Fax
+98 21 6658 1537
Email
drr_anesthesist@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mojgan Rahimi
Street address
Keshavarz blvd
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 2620
Fax
+98 21 6658 1537
Email
drr_anesthesist@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mojgan Rahimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Keshavarz blvd
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 2620
Fax
+98 21 6658 1537
Email
drr_anesthesist@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mojgan Rahimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Keshavarz blvd
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 2620
Fax
+98 21 6658 1537
Email
drr_anesthesist@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mojgan Rahimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Keshavarz blvd
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 2620
Fax
+98 21 6658 1537
Email
drr_anesthesist@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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