Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000719730
Ethics application status
Approved
Date submitted
26/06/2013
Date registered
1/07/2013
Date last updated
1/07/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Supraglottic Airway Devices and effect on phonation - comparison of Proseal LMA and I-gel airway
Scientific title
ASA 1 adults undergoing elective procedures with airway secured by either PLMA or I-gel airway and post-operative phonatory changes
Secondary ID [1] 282741 0
none
Universal Trial Number (UTN)
U1111-1145-0535
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative phonatory dysfunction 289475 0
Dysphonia 289476 0
Condition category
Condition code
Anaesthesiology 289795 289795 0 0
Anaesthetics
Other 289796 289796 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Placement of Supraglottic Airway Devices - either I-gel or Proseal LMA under anaesthesia. Pre and Post operative strobolaryngoscopy and phonetic analysis of voice
I-gel is a newly introduced supraglottic airway device, classified as a cuff less pharyngeal sealer. After administration of general anesthesia and muscle relaxation, airway is placed in oropharynx with tip resting in the upper esophageal sphincter. Square wave capon gram and effective chest raise confirms satisfactory placement.
Intervention code [1] 287404 0
Treatment: Devices
Comparator / control treatment
Active control- Proseal LMA
Proseal LMA is among the most commonly used supraglottic airway devices during anesthesia, classified as a cuffed peri laryngeal sealer with directional sealing and drain tube for stomach. After administration of general anesthesia and muscle relaxation, airway is placed in oropharynx with tip resting in the upper esophageal sphincter. After cuff inflation and ventilation, square wave capon gram and effective chest raise confirms satisfactory placement.
Control group
Active

Outcomes
Primary outcome [1] 289872 0
Postopertive pharyngolaryngeal morbidity including phonatory changes
Phonatory changes are assessed perceptively by speech pathologist by classifying the voice into normal, rough, breathy and asthenia patterns. Phonetic analysis of voice is performed and jitter, shimmer and Harmonic to Noise ratio are analysed as indicators of micro instability of vocal cords
Timepoint [1] 289872 0
24 hours after surgery
Secondary outcome [1] 303447 0
Vocal cord dysfunction
Phonetic analysis of voice is done by using PRAAT software. Jitter, Shimmer and Harmonic to Noise ratio are analysed which are found to correlate with micro instability of vocal cords
Timepoint [1] 303447 0
24 hours after surgery

Eligibility
Key inclusion criteria
Adults belonging to ASA 1 & 2 physical status undergoing surgeries for 60-120 min under general anaesthesia
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Head and neck surgeries, surgeries lasting >120 min, anticipated difficult airway, preoperative abnormality in voice

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2010
Actual
2/08/2010
Date of last participant enrolment
Anticipated
4/06/2012
Actual
4/06/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 5164 0
India
State/province [1] 5164 0

Funding & Sponsors
Funding source category [1] 287514 0
University
Name [1] 287514 0
Jawaharlal Institute of Postgraduate Medical Education and Research
Country [1] 287514 0
India
Primary sponsor type
University
Name
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry
Address
JIPMER, Kamaraj Street, Puducherry, India 605006
Country
India
Secondary sponsor category [1] 286256 0
None
Name [1] 286256 0
Address [1] 286256 0
Country [1] 286256 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289488 0
Institute Ethics committee ( Human Studies ), JIPMER, Puducherry
Ethics committee address [1] 289488 0
JIPMER, Kamraj street, Puducherry , India 605006
Ethics committee country [1] 289488 0
India
Date submitted for ethics approval [1] 289488 0
02/07/2010
Approval date [1] 289488 0
13/01/2011
Ethics approval number [1] 289488 0

Summary
Brief summary
Background: Nerve palsies with Proseal laryngeal mask airway (PLMA) are attributed to nerve compression by the inflated cuff. Cuffless anatomically pre-shaped sealers like I–gel airway (IGA) may minimize nerve compression.
Materials and methods: Ninety ASA1 adults scheduled for surgeries lasting up to 60 to 120 min were included in the study. Participants were randomly allocated to group PLMA (n=43) and group IGA (n=43). Vocal cord function was evaluated by strobolaryngoscopy, perceptive and phonetic analysis of voice (Jitter, Shimmer and Harmonic to Noise Ratio) preoperatively and 24 hours after surgery. Voice of patients with pharyngolaryngeal complaints was categorized into rough, breathy, asthenic, strain or normal pattern.
Results: Jitter (p<0.002), Shimmer (p<0.000) and Harmonic to noise ratio deteriorated significantly in both groups albeit the change being similar in both groups. Incidence of pharyngolaryngeal complaints was 20% and 22.5% in group PLMA and IGA respectively. 10% patients in group PLMA and 12.5% in group IGA developed breathy voice and demonstrated significant deterioration in all phonetic variables. Vocal fold anomalies on stroboscopy were detected in 2 patients in each group.
Conclusion: PLMA and IGA both produce significant deterioration in phonetic variables suggesting vocal cord dysfunction after 1 – 2 hours of anaesthesia.
Trial website
Trial related presentations / publications
Public notes
Institution ethical committee meeting is held within the month after the submission of study protocol i.e. on 02/07/2010 in this particular study, and provisional approval is obtained for recruitment of patients. The final approval is obtained in the form of a certificate after further scrutiny of the study protocol, and this has been the institution practice i.e. 13/01/2011 in this study

Contacts
Principal investigator
Name 41058 0
Dr Shriram Vaidya
Address 41058 0
Department of Anaesthesiology, JIPMER, Puducherry , India 605006
Country 41058 0
India
Phone 41058 0
+918903139960
Fax 41058 0
Email 41058 0
[email protected]
Contact person for public queries
Name 41059 0
Dr Shriram Vaidya
Address 41059 0
Department of Anaesthesiology, JIPMER, Puducherry , India 605006
Country 41059 0
India
Phone 41059 0
+91-0413-2277283
Fax 41059 0
Email 41059 0
[email protected]
Contact person for scientific queries
Name 41060 0
Dr Shriram Vaidya
Address 41060 0
Department of Anaesthesiology, JIPMER, Puducherry , India 605006
Country 41060 0
India
Phone 41060 0
+91-0413-2277283
Fax 41060 0
Email 41060 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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