The comparison of close and open tracheal tube suction on severity of pain and physiological indicators in patients under mechanical ventilation with traumatic brain injuries
The aim of this study is to compare the pain intensity and physiological variables during both open and closed suctions in patients with traumatic brain injuries. This study is a clinical trial. All patients with traumatic brain injuries in Kowsar Hospital in Semnan will form the study society. The main criterion for inclusion is the need for endotracheal suctioning. The most important exclusion criterion is pain before suctioning. The sample size is estimated to be 116. In this study patients are randomly divided into two groups and open and close suctions will be done crossly for them. When the patients undergo open suction, they are disconnected from the ventilator and suction will be performed using a catheter with a pressure less than -120 mm Hg for 14 seconds. When the patients undergo closed suction, they will not be disconnected from the ventilator and suction catheter is inserted via y-piece connector which is placed between endotracheal tube and ventilator tube and suction will be performed. In both groups and in both the first and second turns, pain, systolic and diastolic blood pressure, mean arterial blood pressure, heart rate, respiration rate, spo2 level and Etco2 will be recorded before the intervention, during the intervention and five minutes after it. Then the difference between the studied variable will be compared before and after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016052311399N4
Registration date:2016-06-14, 1395/03/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-06-14, 1395/03/25
Registrant information
Name
Abbasali Ebrahimian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3107 1082
Email address
ebrahimian.aa@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Semnan University of Medical Science
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of close and open tracheal tube suction on severity of pain and physiological indicators in patients under mechanical ventilation with traumatic brain injuries
Public title
The comparison of close and open tracheal tube suction on severity of pain and physiological indicators in patients under mechanical ventilation with traumatic brain injuries
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The Patient is placed under mechanical ventilation simply due to traumatic brain injuries or to subsequent secondary complications; The patient is in a coma and his GCS is less than 8; Endotracheal tube is used for patients in order to get airway; Endotracheal tube is merely through the mouth; They don’t take pain medications; Their livers and kidneys do not have trauma in the latest incident; They don’t take neuromuscular blockers; They need endotracheal tube secretion suctioning and patients don’t have severe face injuries. Exclusion criteria: The patient is brain-dead; They need to regain their suction before two hours; The existence of dangerous cardiac arrhythmias in monitoring patients; Any pain before suctioning; The use of painkillers or drugs on the stimulation of the patient’s upper airway secretions drainage and history of patients’ CPR after hospitalization.
Age
From 35 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
116
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Patients will be divided into two groups by using sealed envelopes method.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Semnan University Of Medical sience
Street address
Vice chancellor for research, Semnan University of Medical Sciences, Basij Blvd
City
Semnan
Postal code
Approval date
2016-05-25, 1395/03/05
Ethics committee reference number
IR.SEMUMS.REC.1395.31
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
R52.9
ICD-10 code description
Pain, unspecified
2
Description of health condition studied
physiological indicators
ICD-10 code
R62.8
ICD-10 code description
Other lack of expected normal physiological development
3
Description of health condition studied
Traumatic brain injuries
ICD-10 code
Intracrani
ICD-10 code description
S06.9
Primary outcomes
1
Description
Pain
Timepoint
Before suctioning, during suctioning, 5 minutes after suctioning
Method of measurement
Critical-care pain objective tool
Secondary outcomes
1
Description
Physiological indicators
Timepoint
Before suctioning, during suctioning, 5 minutes after suctioning
Method of measurement
Monitoring devices, pulse oximetry, recorded ETCo2
Intervention groups
1
Description
Intervention group (1): Patient will receive 100% oxygen for two minutes by ventilator. Then the patient is disconnected from ventilator and suction will be done by sterile method from ventilator and using a catheter number 14 and the pressure less than 120 mm Hg for 14 seconds and consequently the patient’s endotracheal tube is connected to ventilator again and he will be undergone 100% oxygen therapy by ventilator for two minutes.
Category
Other
2
Description
Intervention group (2): Patient will not be disconnected from the ventilator. In these patients the suction catheter goes through the endotracheal tube through Y-piece connector between endotracheal tube and ventilator tube and suction will be done. In these patients suction will be done by catheter suction for 14 seconds with -120 mm Hg.The patient will be undergone 100% oxygen therapy by ventilator before and after suction.