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Comparison of three methods in improving Bag Mask Ventilation

Protocol summary

Summary
In a single blind randomized clinical trial, we studied 300 patients with ASAclass I, II (American Society of Anesthesiologists), Mallampati class (I, II), and age over 55 years in three groups.we tested the hypothesis that placing a packed (two folded) gauze (8 layer - 10 x 10 cm) in each buccal cavity in edentulous patients results in easier bag mask ventilation compared with edentulous patients who have had their dentures were removed or were left in the place . Our Exclusion criteria were full stomach pateints, pateints with NG tube, Fascial Anomali, Mallampati Class IIII, IV, Beard and Snorring. A prospective blind randomized clinical trial performed in Nikookari teaching hospital in Tabriz-Iran. After induction of anesthesia, in group G dentures were removed and in each buccal space an eight-layer10×10 cm gauze and an oral airway were placed. In group D the dentures and an oral airway were left in place. In group C (control), after removing dentures just an appropriate oral airway was placed. Then, each three group underwent bag-mask ventilation. Success of bag-mask ventilation was considered as increase in ETCO2 to more than 20 mmHg and back to Base-Line with FGF=3 Lit/min and APL valve pressure at 20 cmH2O

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138901042496N2
Registration date: 2010-03-24, 1389/01/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-03-24, 1389/01/04
Registrant information
Name
Hassan Soleimanpour
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1329 1286
Email address
soleimanpourh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2008-11-21, 1387/09/01
Expected recruitment end date
2009-11-20, 1388/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of three methods in improving Bag Mask Ventilation
Public title
Comparison of three methods in improving Bag Mask Ventilation
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:Edontulus patient's considering ASA classification(class I and II),mallampati grading system(grade I and II) 2- age(55-100) Exclusion criteria :1- full stomach 2- NG tube 3- Fascial Anomali 4- Mallampati ClaSS IIII,IV 5-Beard 6- Snorring
Age
From 55 years old to 100 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 300
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Vice chancellor of Tabriz University of Medical Sciences
Street address
Research Vice chancellor of Tabriz University of Medical Sciences ,Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN.
City
Tabriz
Postal code
51664
Approval date
empty
Ethics committee reference number
8713

Health conditions studied

1

Description of health condition studied
The Effect of Using Packed Gauze in the Edentulous Patients on facility of Bag Mask Ventilation
ICD-10 code
T88.4
ICD-10 code description
failed or difficult intubation

Primary outcomes

1

Description
Successful bag mask ventilation rates
Timepoint
3 minute
Method of measurement
increase in End Tidal co2 to 20 mm Hg and back to baseline with 3 L/min fresh gas flow and the adjustable pressure limiting valve at 20 cm H2O.

Secondary outcomes

empty

Intervention groups

1

Description
placing a packed (two folded) gauze (8 layer - 10 x 10 cm) in each buccal cavity in edentulous patients
Category
Other

2

Description
we placed only an oral airway
Category
N/A

3

Description
The dentures and an oral airway were left in place.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Nikookari hospital
Full name of responsible person
Street address
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Vice chancellor of Tabriz University of Medical Sciences
Full name of responsible person
Mir Ali Eteraf Oskouei
Street address
Research Vice chancellor of Tabriz University of Medical Sciences ,Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice chancellor of Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Research Vice chancellor of Tabriz University of Medical Sciences
Full name of responsible person
Hassan Soleimanpour
Position
Assistant professor of Anesthesiology
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN.
City
Tabriz
Postal code
Phone
+98 41 1329 1286
Fax
Email
soleimanpourh@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hassan Soleimanpour
Position
Assistant professor of Anesthesiology
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN.
City
Tabriz
Postal code
Phone
+98 41 1329 1286
Fax
Email
soleimanpourh@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Research Vice chancellor of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mir Ali Eteraf Oskouei
Position
Research Vice chancellor
Other areas of specialty/work
Street address
Research Vice chancellor of Tabriz University of Medical Sciences ,Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN.
City
Tabriz
Postal code
51664
Phone
+98 41 1335 7313
Fax
Email
mpajhouheshi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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