Contact information
Type
Scientific
Primary contact
Dr Ulderico Freo
ORCID ID
Contact details
Istituto di Anestesiologia
Dipartimento di Farmacologia e Anestesiologia
Via C. Battisti
267
Padova
35121
Italy
+39 (0)49 821 3094
ulderico.freo@unipd.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1615P
Study information
Scientific title
Comparison study on ventilation with laryngeal mask and with endotracheal tube for bariatric surgery
Acronym
Study hypothesis
Ventilation with laryngeal mask results in better recovery profile than ventilation with endotracheal tube in obese patients undergoing bariatric surgery.
Ethics approval
This study was approved by the Ethics Committee, Padua Hospital on 25/07/2008.
Study design
Randomised double-blind (patient, evaluating physician) trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Obesity
Intervention
Ventilation with laryngeal mask vs ventilation with endotracheal tuber
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Time to independent walking after the end of anesthesia
Secondary outcome measures
1. Ventilatory parameters
2. Postoperative morbidity
3. Patient and surgeon satisfaction
Overall trial start date
08/01/2008
Overall trial end date
08/01/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Both males and females, age >18 years
2. American Society of Anaesthesiologists (ASA) classification I-III
3. Obese patients (body mass index [BMI] >30) undergoing bariatric surgery
4. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
124
Participant exclusion criteria
1. Psychiatric disorders
2. Drug abuse
3. Known or possible pregnancy
4. Previous airway pathology
5. Pulmonary diseases
6. History of gastro-oesophageal reflux
Recruitment start date
08/01/2008
Recruitment end date
08/01/2011
Locations
Countries of recruitment
Italy
Trial participating centre
Istituto di Anestesiologia
Padova
35121
Italy
Sponsor information
Organisation
Department of Pharmacology and Anaesthesiology, Padua University (Italy)
Sponsor details
c/o Prof Carlo Ori
Istituto di Anestesiologia
Dipartimento di Farmacologia e di Anestesiologia
Università di Padova
Padova
35121
Italy
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Department of Pharmacology and Anaesthesiology, Padua University (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary