Protocol summary

Summary
Study objectives: efficiency and ease of use of two types of face masks or respirators mouth or nose in non-invasive ventilation in patients with acute respiratory failure scholar at Christ's Hospital Study Design: The study is double-blind clinical trial. How the study: First, patients randomly into two groups based on the use of masks or masks for the face, mouth or nose fall. Typically non-invasive ventilation, continuously for 24 hours will apply. In both groups, if the patient received the first mask, not tolerate, before disconnecting non-invasive ventilation mask will be the second try. Conditions of entry and exit from the study: Inclusion criteria included the following: patients with acute respiratory failure; Tachypnea (respiratory rate more than 24); The use of sub-breathing muscles; Paradoxical breathing; Respiratory acidosis Exclusion criteria include: alteration of consciousness; Respiratory hypersecretion; Unstable coronary disease; Arrhythmia leading to unstable blood pressure; Arterial oxygen saturation less than 90% or greater than 40 mm Hg drop from Fsharqbly; Large skin lesion; Trauma to the face; Upper airway obstruction; Recent surgery on the upper airway, stomach and esophagus; A situation that requires immediate intubation. The main outcome variables: the convenience of using a mask with a score of 0 to 10. Secondary outcome variables: venous blood gas profile

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016051627929N1
Registration date: 2016-06-15, 1395/03/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-06-15, 1395/03/26
Registrant information
Name
Atefeh Fakharian
Name of organization / entity
National research institute of tuberculosis and lung diseases
Country
Iran (Islamic Republic of)
Phone
+98 21 2712 2541
Email address
afakharian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
From the budget of thesis
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Comfortability and Effectiveness of Total Face Mask and Oronasal Mask in Non-invasive Positive Pressure Ventilation in Patients with Acute Respiratory Failure
Public title
Comfortability and Effectiveness of Non-invasive Positive Pressure Ventilation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included the following: patients with acute respiratory failure; Tachypnea (respiratory rate more than 24); The use of sub-breathing muscles; Paradoxical breathing; Respiratory acidosis Exclusion criteria include: alteration of consciousness; Respiratory hypersecretion; Unstable coronary disease; Arrhythmia leading to unstable blood pressure; Arterial oxygen saturation less than 90% or greater than 40 mm Hg drop from Fsharqbly; Large skin lesion; Trauma to the face; Upper airway obstruction; Recent surgery on the upper airway, stomach and esophagus; A situation that requires immediate intubation.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
7th Floor , 2nd SBUMS Bldg. ,Next to Ayatollah Taleghani Hospital, Evin
City
Tehran
Postal code
Approval date
2014-07-02, 1393/04/11
Ethics committee reference number
sbmu1.REC.1393.65

Health conditions studied

1

Description of health condition studied
respiratory failure
ICD-10 code
J96.0
ICD-10 code description
Acute respiratory failure

Primary outcomes

1

Description
comfortability of mask
Timepoint
daily
Method of measurement
visual analog scale (VAS) questionnaire

Secondary outcomes

1

Description
Venous PH
Timepoint
Daily
Method of measurement
venous blood gass

2

Description
Venous PCO2
Timepoint
Daily
Method of measurement
venous blood gass

3

Description
Venous HCO3-
Timepoint
Daily
Method of measurement
venous blood gass

Intervention groups

1

Description
In the intervention group: the mouth or nose mask is used. Non-invasive device configurations based on guidelines published by the Lung Association will be conducted in Europe and America. The mask is placed on the patient for 24 hours. If the patient's mouth mask used to mask other group used In the second group of face mask is used. Non-invasive device settings in this group are similar to the first group and based on guidelines published by the Lung Association is done in Europe and America.
Category
Treatment - Devices

2

Description
In control group,Full face masks used in the control group. Non-invasive device settings in this group are similar groups on the basis of guidelines published by the Lung Association is done in Europe and America. The mask is placed on the patient for 24 hours. If the patient fails to mask another mask for used
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
National Research Institute of Tuberculosis and Lung Diseases
Full name of responsible person
Atefeh Fakharian
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti university of medical sciences
Full name of responsible person
Dr. Afshin Rezghi
Street address
7th Floor , 2nd SBUMS Bldg. ,Next to Ayatollah Taleghani Hospital, Evin
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahid Beheshti 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
National Research Institute of Tuberculosis and Lung Diseases
Full name of responsible person
Atefeh Fakharian
Position
Pulmonologist
Other areas of specialty/work
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout
City
tehran
Postal code
1956944413
Phone
+98 912 103 0850
Fax
Email
fakharian_2005@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
National Research Institute of Tuberculosis and Lung Diseases
Full name of responsible person
Atefeh Fakharian
Position
pulmonologyst
Other areas of specialty/work
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout
City
Tehran
Postal code
1956944413
Phone
+98 21 2712 2541
Fax
Email
fakharian_2005@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
National Research Institute of Tuberculosis and Lung Diseases
Full name of responsible person
Atefeh Fakharian
Position
Pulmonologist
Other areas of specialty/work
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout
City
Tehran
Postal code
1956944413
Phone
+98 21 2712 2541
Fax
Email
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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