Protocol summary

Summary
This clinical trial with aims comparison effects the endotracheal suctioning with three methods, with installing normal saline serum, installing N-acethylcycteine and without those on physiologic parameters and amount of secretions at intubated patients hospitalized in intensive care units. With convenient sampling method on 54 patients will be randomly assigned. In all cases all three suction with saline without and with N-acetylcysteine are implicated. Inclusion criteria: age over 15 years old, with an endotracheal tube; the increased intracranial pressure; hemodynamic status fixed without severe heart failure; chronic obstructive pulmonary disease and had no other history of drug addiction. Exclusion criteria: existence tracheostomy tube; use of inotropic drugs; application of broncoscopy; septic shock; application of endotracheal suctioning in at least 2 hours. Blood pressure, heart rate, respiratory rate and oxygen saturation measure and record at before, two and five minutes after of each method suctioning by standard monitoring apparatus. Amount of secretion measure and record after of each method suctioning. All patients receive 100% oxygen before and after each suction.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201303115866N7
Registration date: 2013-04-12, 1392/01/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-04-12, 1392/01/23
Registrant information
Name
Akram Sanagoo
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1443 0360
Email address
sanagoo@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research and technology deputy Golestan University Of Medical Sciences, Gorgan, Iran
Expected recruitment start date
2013-03-14, 1391/12/24
Expected recruitment end date
2013-07-21, 1392/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effects the Endotracheal suctioning with three methods,with installing normal saline serum,Installing N-acethylcycteine and without those on physiologic parameters and Amount of secretions at intubated patients hospitalizated in intensive care units
Public title
Comparison effects the Endotracheal suctioning with three methods,with installing normal saline serum,Installing N-acethylcycteine and without those on physiologic parameters and Amount of secretions at intubated patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients older than 15 years old; patient without intra cranial pressure; hemodynamics stability; patient without chronic obstruction pulmonary disease; patient without addiction; patient with Endotracheal tube; patient without severe heart failure. Exclusion criteria: existence tracheostomy tube; use of inotropic drugs; application of broncoscopy; septic shock; application of endotracheal suctioning in at least 2 hours.
Age
From 15 years old to 149 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 54
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
Golestan University of Medical Sciences
Street address
Shastkola Road
City
Gorgan
Postal code
49165568
Approval date
2013-02-17, 1391/11/29
Ethics committee reference number
29459111291

Health conditions studied

1

Description of health condition studied
Symptoms, signs and abnormal clinical and laboratory findings
ICD-10 code
R00-R99
ICD-10 code description
Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified

Primary outcomes

1

Description
Saturation of O2
Timepoint
Befor suction, 2 and 5 minutes after suction
Method of measurement
Pulse oximetry

2

Description
Blood pressure
Timepoint
Befor suction, 2 and 5 minutes after suction
Method of measurement
Sphygmomanometer

3

Description
Pulse rate
Timepoint
Befor suction, 2 and 5 minutes after suction
Method of measurement
Enumeration

4

Description
Respiratory rate
Timepoint
Befor suction, 2 and 5 minutes after suction
Method of measurement
Enumeration

Secondary outcomes

empty

Intervention groups

1

Description
All three methods are used in all patients the first time suction with saline; if need suction, 3 cc of sterile saline and then using a suction catheter of the endotracheal tube, the patient is suctioned.
Category
Prevention

2

Description
In the second round, if necessary, this time without the use of normal saline and then suctioning using
Category
Treatment - Drugs

3

Description
If you need to suction the third time, the amount of liquid 2 ml - 2 ml pulled acetylcysteine ​​in patients endotracheal tube is then suctioned.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Beheshti Teaching Hospital
Full name of responsible person
Nad Ali Akbaryan
Street address
Beheshti and rohani and yahyanejad Teaching Hospital
City
Baboll

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputy of Golestan University Of Medical Sciences, Gorgan, Iran
Full name of responsible person
Mohammad Jafar Golalipour
Street address
Golestan University of Medical Sciences, Shastkola
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Golestan University Of Medical Sciences, Gorgan, Iran
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
Golestan University of Medical Sciences
Full name of responsible person
Akram Sanagoo
Position
Assosiate professor
Other areas of specialty/work
Street address
Golestan University of Medical Sciences, Shastkola
City
Gorgan
Postal code
49165568
Phone
+98 17 1443 0360
Fax
+98 17 1442 5171
Email
a_sanagu@yahoo.com
Web page address
www.Goums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Akram Sanagoo
Position
Assosiate professor
Other areas of specialty/work
Street address
Golestan University of Medical Sciences, Shastkola
City
Gorgan
Postal code
49165568
Phone
+98 17 1443 0360
Fax
+98 17 1442 5171
Email
a_sanagu@yahoo.com
Web page address
www.Goums.ac.ir

Person responsible for updating data

Contact

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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