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Endotracheal intubation with laryngeal mask airway and bougie versus video laryngoscope in patients with difficult airway

Protocol summary

Summary
Objectives: Selecting the appropriate method of intubation in patients with difficult airway, is an important challenge for anesthesiologists because repeated attempts of intubation increase complications such as hypoxia, hemodynamic abnormalities, aspiration and damage to the airway. The aim of this study is to compare the endotracheal intubation with laryngeal mask airway and bougie versus video laryngoscope in patients with difficult airway. Design: Block randomization, without placebo, double center, trial phase 2, including 90 patients who are candidate for elective surgeries. Setting and conduct: Fentanyl, 1 µg/kg, IV injection to induce anesthesia. Propofol, 2 mg/kg, IV injection to induce anesthesia. Participants including major eligibility criteria: All patients who are candidate for elective surgeries. Intervention: Endotracheal intubation with video laryngoscope Endotracheal intubation with laryngeal mask airway and bougie Main outcome measures: Ease of intubation, Duration of intubation, Systolic blood pressure, Diastolic blood pressure, O2 saturation, Heart rate.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015102214056N6
Registration date: 2015-10-26, 1394/08/04
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-10-26, 1394/08/04
Registrant information
Name
Hesameddin Modir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3313 9680
Email address
he_modir@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences, Vice Chancellor for Research
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Endotracheal intubation with laryngeal mask airway and bougie versus video laryngoscope in patients with difficult airway
Public title
Breathing intubation with two different methods in patients with difficult intubation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: ASA class I–II; Age between 18-65 years old; Mallampati class III-IV; Negative upper lip bite test; Patients satisfaction; Not pregnant; No history of cardiovascular diseases (Arrhythmia, ischemia, and heart block); No history of coagulopathies; Not taking opioids. Exclusion criteria: Insufficient ventilation or lack of ventilation in time of induction.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 90
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 Arak University of Medical Sciences
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Postal code
IR.ARAKMU.REC.1394.4
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
IR.ARAKMU.REC.1394.43

Health conditions studied

1

Description of health condition studied
Difficult intubation
ICD-10 code
T88.4
ICD-10 code description
Failed or difficult intubation

Primary outcomes

1

Description
Ease of intubation
Timepoint
After intubation
Method of measurement
Qualitative score

2

Description
The duration of intubation
Timepoint
After intubation
Method of measurement
Quantitative

Secondary outcomes

empty

Intervention groups

1

Description
Intervention 1. Endotracheal intubation with video laryngoscope.
Category
Other

2

Description
Intervention 2. Endotracheal intubation with laryngeal mask airway and bougie.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir kabir hospital
Full name of responsible person
Dr Hesameddin Modir
Street address
Amir kabir hospital. Parastar square. Rah-Ahan street. Arak. Iran
City
Arak

2

Recruitment center
Name of recruitment center
Vali asr hospital
Full name of responsible person
Dr Hesameddin Modir
Street address
Vali asr hospital. Vali asr square. Arak. Iran
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences, Vice Chancellor for Research
Full name of responsible person
Dr Ali Asghar Yaghoobi
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences, Vice Chancellor for Research
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
Arak University of Medical Sciences
Full name of responsible person
Dr Hesameddin Modir
Position
Anesthesiologist
Other areas of specialty/work
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Postal code
Phone
+98 86 3417 3641
Fax
Email
He_modir@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Hesameddin Modir
Position
Anesthesiologist
Other areas of specialty/work
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Postal code
Phone
+98 86 3417 3641
Fax
Email
He_modir@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Hesameddin Modir
Position
Anesthesiologist
Other areas of specialty/work
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Postal code
Phone
+98 86 3417 3641
Fax
Email
He_modir@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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