Main goal of the study is to assess airway pressure in asthmatic patients anesthetized by LMA or ETT (during first 20 minutes after induction of anesthesia and afterwards).
Design: Twenty patients will be enrolled in each group (L who received LMA or T who received ETT).
Method: They both receive same protocol for induction (propofol, cisatracurium, fentanyl, midazolam) and maintenace.
Outcomes: Airway pressure at each breath (continuously during first 20 minutes and every 5 minutes afterwards) and arterila saturation will be assessed and out of predefined values will be recorded and treated accordingly. Patients will be extubated in a fully awake status. Cough, desaturation, nausea , vomitting, dyspnea and wheeze will be evaluated in recovery.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT201511223436N5
Registration date:2015-12-23, 1394/10/02
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-12-23, 1394/10/02
Registrant information
Name
Babak Gharaei
Name of organization / entity
Labbafijejad Hospital, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2254 9029
Email address
b.gharaei@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-01-20, 1394/10/30
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Laryngeal mask airway (LMA) compared to endotrachal tube (ETT) for mild asthmatic patients undergoing emergent surgery regarding airway pressure
Public title
General anesthesia in asthmatic patients, airway management
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion: aged 16-59. no cardiac problem. no medical problem except asthma. asthma can be active however should be categorized as mild with no respiratory distress or desaturation less than 90%.
Exclusion: surgery duration more than 2 hours. Changing head position more than three times in the surgery.
Age
From 16 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Shahid Beheshti University of Medical Sciences
Street address
Velenjak, Daneshjoo Sq, Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
Approval date
2015-08-25, 1394/06/03
Ethics committee reference number
IR.SBMU.SM.REC.1394.18
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45-2, J45
ICD-10 code description
Mild intermittent and persistant asthma
Primary outcomes
1
Description
Arterial oxygen desaturation
Timepoint
Continuous pulse measurement during anesthesia and recovery
Method of measurement
arteril oxygen desaturation to less than 90% for longer than one minute
2
Description
Airway pressure more than 30 with LMA or 50 by ETT
Timepoint
continuous- breath by breath in the first 20 minutes and every 5 minutes afterwards
Method of measurement
Airway pressure in CmH2o by Anesthesia machine
Secondary outcomes
1
Description
Nausea and vomiting
Timepoint
Every 5 minutes in recovery
Method of measurement
Asking from the patient
2
Description
Dyspnea
Timepoint
Every 5 minutes in recovery after being fully awake
Method of measurement
asking from the patient
3
Description
Respiratory wheeze
Timepoint
Every 30 minutes in recovery
Method of measurement
Auscultation for wheeze (inspiratory -expiratory- mild, moderate or severe)
Intervention groups
1
Description
Intervention in T group: After induction and in deep state of anesthesia with proper muscle relaxation, appropriate size ETT (SUPA Co. Tehran, Iran) is placed for the patient.
Category
Prevention
2
Description
Intervrntion in L group: After induction and in deep state of anesthesia with proper muscle relaxation, appropriate size LMA (Well Lead, China) is placed for the patient.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Labbafinejad Hospital
Full name of responsible person
Babak Gharaei
Street address
9th Boostan, Paydar fard, Pasdaran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Babak gharaei
Street address
Labbafinejad , 9th Boostan, Pasdaran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
Medical School, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Babak Gharaei
Position
Associate Professor
Other areas of specialty/work
Street address
Labbafinejad Hospital, 9th Boostan, Pasdaran
City
Tehran
Postal code
1666663111
Phone
+98 21 2360 2175
Fax
Email
b.gharaei@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical School, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Babak Gharaei
Position
Associate Professor
Other areas of specialty/work
Street address
Labbafinejad Hospital, 9th Boostan, Pasdaran
City
Tehran
Postal code
1666663111
Phone
+98 21 2360 2175
Fax
Email
b.gharaei@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Medical School, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Babak Gharaei
Position
Associate Professor
Other areas of specialty/work
Street address
Labbafinejad Hospital, 9th Boostan, Pasdaran
City
Tehran
Postal code
1666663111
Phone
+98 21 2360 2175
Fax
Email
b.gharaei@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)