The comparison of respiratory parameters in mechanical ventilation with Adaptive Support Ventilation (ASV) and Synchronized Intermittent Mandatory Ventilation (SIMV) in the hospitalized neurosurgical patients in ICU
Objectives: The comparison of respiratory parameters in mechanical ventilation with Adaptive Support Ventilation (ASV) and Synchronized Intermittent Mandatory Ventilation (SIMV) in the hospitalized neurosurgical patients in ICU. Design: crossover randomized clinical trial, blocking randomization, single blind, Setting and conduct: one center (Firouzgar hospital, Tehran). Sample size: 54 patients. Interventions: for 30 minute 27 patients will be put on SIMV mode and 27 patients will be put on ASV mode, and then 2 groups will be relocated. Respiratory parameters will be measured at the first, during and at the end of each intervention. Major inclusion criteria: hospitalized in neurosurgery ICU; decreased consciousness; need to intubation and mechanical ventilation; no respiratory failure. Major exclusion criteria: severe liver failure; severe kidney failure; severe lung disease; confirmed obstructive lung diseases; confirmed restrictive lung diseases; heart failure; respiratory failure; involvement or lesion of brain stem. Main outcome measures: plateau pressure rate, peak flow rate, tidal volume, respiratory rate, arterial mean pressure, peripheral O2 saturation rate (SPO2)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015112016151N3
Registration date:2015-11-28, 1394/09/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-28, 1394/09/07
Registrant information
Name
Alireza Pournajafian
Name of organization / entity
Iran University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 6762
Email address
a-pournajafian@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of respiratory parameters in mechanical ventilation with Adaptive Support Ventilation (ASV) and Synchronized Intermittent Mandatory Ventilation (SIMV) in the hospitalized neurosurgical patients in ICU
Public title
comparison of Adaptive Support Ventilation (ASV) and Synchronized Intermittent Mandatory Ventilation (SIMV) modes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: hospitalized in neurosurgery ICU; decreased consciousness; need to intubation and mechanical ventilation; no respiratory failure. Exclusion criteria: severe liver failure (ascites, abnormal liver function tests); severe liver and renal failure ; severe lung disease based on PFT (FEV1<50%); confirmed obstructive lung diseases (asthma, emphysema, chronic bronchitis, small airway disease); bronchiectasis; confirmed restrictive lung diseases (fibrosis of lungs); heart failure (EF<45%); obesity (BMI>30); pregnancy; smoking; respiratory failure (MAP<60 mm/Hg, T>38, PH<7.3, PCO2>50, PO2<60 with FiO2<0.6); involvement or lesion of brain stem.
Age
To 100 years old
Gender
Both
Phase
3
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
Crossover
Other design features
Randomization with blocking method
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Iran University of Medical Sciences
Street address
hemmat highway, tehran
City
Tehran
Postal code
Approval date
2014-07-06, 1393/04/15
Ethics committee reference number
105/1678/د/ 93
Health conditions studied
1
Description of health condition studied
mechanical ventilation
ICD-10 code
Z51.8
ICD-10 code description
Other specified medical care
Primary outcomes
1
Description
peak airway pressure
Timepoint
minutes 10,20,30
Method of measurement
cm H2O by ventilator
2
Description
static lung compliance
Timepoint
30 minutes after intervention
Method of measurement
ml/cm H20 by ventilator
3
Description
dynamic lung compliance
Timepoint
30 minutes after intervention
Method of measurement
ml/cm H20 by ventilator
Secondary outcomes
1
Description
arterial CO2
Timepoint
minutes 10,20,30
Method of measurement
mmHg by ABG
2
Description
arterial oxygen presuure
Timepoint
minutes 10,20,30
Method of measurement
mmHg by ABG
3
Description
respiratory rate
Timepoint
minutes 10,20,30
Method of measurement
rate in minute
Intervention groups
1
Description
Intervention group 1: sedation will be done for patients (with propofol 1-2 mg/kg/h) if they need. Patients will be given 1 mg midazolam (bolus) if they can’t tolerate the tracheal tube (to be in Ramsy Score: 2-4). Analgesia level will be regulated for all patients with fentanyl based on VAS (0-3), between complete analgesia to mild pain. Patients will be put on SIMV mode for 30 min (FiO2:60%، TV: 8 cc/kg، PEEP: 3-5 cmH2O if arterial mean pressure>60 mmHg, ASB: 10 cmH2O, RR=12/min, ETCO2= 30-35, trigger: 3-5). Outcomes will be measured at 10, 20 and 30 min. Then patients will be put on ASV mode for 30 min and Outcomes will be measured again.
Category
Treatment - Devices
2
Description
Intervention group 2: sedation will be done for patients (with propofol 1-2 mg/kg/h) if they need. Patients will be given 1 mg midazolam (bolus) if they can’t tolerate the tracheal tube (to be in Ramsy Score: 2-4). Analgesia level will be regulated for all patients with fentanyl based on VAS (0-3), between complete analgesia to mild pain. Patients will be put on ASV mode for 30 min (FiO2:60%، TV: 8 cc/kg، PEEP: 3-5 cmH2O if arterial mean pressure>60 mmHg, ASB: 10 cmH2O, RR=12/min, ETCO2= 30-35, trigger: 3-5). Outcomes will be measured at 10, 20 and 30 min. Then patients will be put on SIMV mode for 30 min and Outcomes will be measured again.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Dr Mohammad Hosein Hemadi
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of research of Iran University of Medical Sciences
Full name of responsible person
Dr Mohammad Mousavi
Street address
Next to Milad tower, Hemmat highway
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 of research of Iran University of Medical Sciences