Objective: comparison of the effects of routine and minimally invasive endotracheal suctioning methods on suction related pain, airway clearance, airway trauma and physiological indices in patients hospitalized in intensive care units of Al-Zahra Hospital in 2015.
Study design: randomized clinical trial.
Study population: patients admitted to the intensive care unit at Al-Zahra Hospital.
Major inclusion criteria: age over than 18; obtaining informed consent; no blood clotting disorders; no chronic respiratory disease; intubation time between 48 hours and one week. Major exclusion criteria: patients who would discontinue voluntarily; estuation during the study; become unstable hemodynamic parameters such as bradycardia, arrhythmia, cyanosis, loss of arterial oxygen.
Sample size: 60 patients.
Intervention: in the routine endotracheal suction the method of suctioning will be deep, with normal saline instillation, and with negative pressure of 100-200 mm Hg. In the minimally invasive endotracheal suction the method of suctioning will be shallow, without normal saline instillation, and with negative pressure of 80-120 mm Hg. Design variables will be taken immediately before, immediately after, and 10 minutes after endotracheal suctioning in both groups. Primary outcomes: changes in physiological indices.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015072423314N1
Registration date:2015-08-12, 1394/05/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-12, 1394/05/21
Registrant information
Name
Mohammad Abbasinia
Name of organization / entity
Qom university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 3242 4753
Email address
mabasiniya@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2015-08-10, 1394/05/19
Expected recruitment end date
2015-10-29, 1394/08/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects of routine versus a minimally invasive endotracheal suctioning
Public title
The effects of routine versus a minimally invasive endotracheal tube suctioning procedure on suction-related pain, airway clearance, airway trauma and physiological indices in patients hospitalized in intensive care units of Al-Zahra Hospital of Isfahan in 2015.
Purpose
Treatment
Inclusion/Exclusion criteria
Major inclusion criteria: age over than 18; obtaining informed consent; no blood clotting disorders; no chronic respiratory disease; intubation time between 48 hours and one week. Major exclusion criteria: extubation during the study; become unstable hemodynamic parameters such as bradycardia, arrhythmia, cyanosis, loss of arterial oxygen.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not 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 Isfahan university of medical sciences
Street address
Isfahan University of Medical Sciences, Azadi Square, Hezar-Jerib street, Isfahan. Postal cod: 81746-73461
City
Isfahan
Postal code
Approval date
2014-11-26, 1393/09/05
Ethics committee reference number
294003
Health conditions studied
1
Description of health condition studied
Respiratory conditions due to other specified external agents
ICD-10 code
J70.8
ICD-10 code description
Respiratory conditions due to other specified external agents
Primary outcomes
1
Description
Pain
Timepoint
Immediately before, immediately after, and 10 min after endotracheal suctioning
Method of measurement
With numeral rating scale (NRS)
Secondary outcomes
1
Description
Blood pressure
Timepoint
Immediately before, immediately after, and 10 min after endotracheal suctioning
Method of measurement
With vital signs monitoring devices
2
Description
Heart Rate
Timepoint
Immediately before, immediately after, and 10 min after endotracheal suctioning
Method of measurement
With vital signs monitoring devices
3
Description
Respiratory Rate
Timepoint
Immediately before, immediately after, and 10 min after endotracheal suctioning
Method of measurement
With vital signs monitoring devices
4
Description
Spo2
Timepoint
Immediately before, immediately after, and 10 min after endotracheal suctioning
Method of measurement
With vital signs monitoring devices
5
Description
Number of endotracheal suctioning
Timepoint
After each endotracheal suctioning
Method of measurement
Counting the number of endotracheal suctioning
6
Description
Airway traumatization
Timepoint
After endotracheal suctioning
Method of measurement
Viewing bleeding in the airways
Intervention groups
1
Description
In intervention group (minimally invasive endotracheal tube suctioning) the patients were hyper oxygenated only by ventilator for one minute, short suction catheter with effective length was introduced only into the end of the endotracheal tube, a negative pressure (80-120 mmHg) was applied for a maximum duration of 10 seconds while removing the catheter, Manual hyperinflation and installation of normal saline were not applied in this group.
Category
Treatment - Other
2
Description
In control group (routin endotracheal tube suctioning) after disconnecting the patients from the ventilator, manual hyper oxygenation and hyperventilation was carried out for one minute, a suction catheter with an effective length was introduced into the endotracheal tube until resistance was met (reached the carina), after that it was retracted a centimeter and a negative pressure (100-200 mmHg) was applied for a maximum duration of 10 seconds while removing the catheter, Normal saline was instilled before the each suctioning.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Street address
Al-Zahra Hospital, Sofeh Avenue, Isfahan. Postal cod: 81746-75731
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Dr Mohammad Hashemi
Street address
Isfahan University of Medical Sciences, Azadi Square, Hezar-Jerib street, Isfahan. Postal cod: 81746-73461
City
Isfahan
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, Isfahan 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
Isfahan University of Medical sciences
Full name of responsible person
Mahdi Shamali
Position
MSc in critical care nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Azadi Square, Hezar-Jerib street, Isfahan. Postal cod: 81746-73461
City
Isfahan
Postal code
Phone
+98 31 3792 2917
Fax
Email
gezaltoshmal@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan university of medical sciences
Full name of responsible person
Mahdi Shamali
Position
MSc in critical care nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Azadi Square, Hezar-Jerib street, Isfahan. Postal cod: 81746-73461
City
Isfahan
Postal code
Phone
+98 31 3792 2917
Fax
Email
gezaltoshmal@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qom University of Medical sciences
Full name of responsible person
Mohammad Abbasinia
Position
MSc in critical care nursing
Other areas of specialty/work
Street address
No. 251, 14 Metrye Emam Hosein, Qom.
City
Qom
Postal code
3717978311
Phone
+98 25 3885 0824
Fax
Email
armak1364@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)