The main purpose of this study is to compare respiratory complications of tracheal tube and laryngeal mask airway after prolonged Ear, Nose, Throat surgeries. Candidates must not have any contraindication for using laryngeal mast airway and their surgery must not have any influence on postoperative respiratory complications. Candidates of prolonged (>2hours )ear, nose, throat surgery in Hazrat Rasol Medical Complex were the target population of our study. 171 patients of study were divided into two groups and in the first group laryngeal mask airway and in second group tracheal tube was used for airway control during surgery. The incidences of four postoperative complications: sore throat, hoarseness , cough and shortness of breath were recorded in immediate postoperative period and compared in the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013102215108N1
Registration date:2014-01-03, 1392/10/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-03, 1392/10/13
Registrant information
Name
Reza Safaeian
Name of organization / entity
Iran University of medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4464 0531
Email address
rezasafaa@hotmail.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of postoperative respiratory complications of Laryngeal Mask Airway and Tracheal tube in candidates of prolonged ENT operations
Public title
Comparison of postoperative respiratory complications of Laryngeal Mask Airway and Tracheal tube in candidates of prolonged ENT operations
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ASA I and II patients; candidates for ENT surgeries of more than two hours duration; age more than 13y old; mallampati score of 1 or 2; no positive history of chronic or acute respiratory diseases or smoking; Exclusion criteria: Obese patients; pregnant women; patients with gastroesophageal reflux; patients with surgeries on throat and lower regions of respiratory system
Age
No age limit
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
171
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research committee of Anesthesiology Department
Street address
Rasoul Akram Hospital
City
Tehran
Postal code
Approval date
2012-01-21, 1390/11/01
Ethics committee reference number
ارسال ميشود
Health conditions studied
1
Description of health condition studied
Respiratory complications of airway control devices
ICD-10 code
S00-T98
ICD-10 code description
-injury, poisoning and certain other consequences of external causes
Primary outcomes
1
Description
Sore Throat
Timepoint
2 hours after operation
Method of measurement
Asking from the patient
2
Description
Hoarsness
Timepoint
2 hours after operation
Method of measurement
Asking from the patient
3
Description
Cough
Timepoint
2 hours after operation
Method of measurement
Asking from the patient
4
Description
Shortness of breath
Timepoint
2 hours after operation
Method of measurement
Asking from the patient and direct observation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Laryngeal Mask Airway will be used. This was done using classic method without any introducer by Anesthesiology specialist trainees
Category
Treatment - Devices
2
Description
Control group: Endotracheal intubation by anesthesiology specialist trainees
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Dr Reza Safaeian
Street address
Niayesh St., Satarkhan St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor For research, Iran university of Medical Sciences
Full name of responsible person
Dr Motavalian
Street address
Hemmat Freeway, Next to Milad tower
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 For research, Iran 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
Iran University of Medical Sciences
Full name of responsible person
Reza Safaeian
Position
Faculty member/ Anesthesiologist
Other areas of specialty/work
Street address
Rasoul Akram Hospital, Niayesh St., Satarkhan St.
City
Tehran
Postal code
Phone
+98 21 4464 0531
Fax
Email
rezasafaa@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Safaeian
Position
Faculty member/ Anesthesiologist
Other areas of specialty/work
Street address
Rasoul Akram Hospital, Niayesh St., Satarkhan St.
City
Tehran
Postal code
Phone
+98 21 4464 0531
Fax
-
Email
rezasafaa@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Safaeian
Position
Faculty member/ Anesthesiologist
Other areas of specialty/work
Street address
Rasoul Akram Hospital, Niayesh St., Satarkhan St.
City
Tehran
Postal code
Phone
+98 21 4464 0531
Fax
-
Email
rezasafaa@hotmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)