Laryngeal mask vs endotracheal tube for bariatric surgery
| ISRCTN | ISRCTN18342801 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18342801 |
| Secondary identifying numbers | 1615P |
- Submission date
- 26/08/2008
- Registration date
- 18/09/2008
- Last edited
- 18/09/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ulderico Freo
Scientific
Scientific
Istituto di Anestesiologia
Dipartimento di Farmacologia e Anestesiologia
Via C. Battisti, 267
Padova
35121
Italy
| Phone | +39 (0)49 821 3094 |
|---|---|
| ulderico.freo@unipd.it |
Study information
| Study design | Randomised double-blind (patient, evaluating physician) trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Comparison study on ventilation with laryngeal mask and with endotracheal tube for bariatric surgery |
| Study objectives | Ventilation with laryngeal mask results in better recovery profile than ventilation with endotracheal tube in obese patients undergoing bariatric surgery. |
| Ethics approval(s) | This study was approved by the Ethics Committee, Padua Hospital on 25/07/2008. |
| Health condition(s) or problem(s) studied | Obesity |
| Intervention | Ventilation with laryngeal mask vs ventilation with endotracheal tuber |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 08/01/2008 |
| Completion date | 08/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 124 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 08/01/2008 |
| Date of final enrolment | 08/01/2011 |
Locations
Countries of recruitment
- Italy
Study participating centre
Istituto di Anestesiologia
Padova
35121
Italy
35121
Italy
Sponsor information
Department of Pharmacology and Anaesthesiology, Padua University (Italy)
University/education
University/education
c/o Prof Carlo Ori
Istituto di Anestesiologia
Dipartimento di Farmacologia e di Anestesiologia
Università di Padova
Padova
35121
Italy
| Website | http://www.istar.unipd.it |
|---|---|
"ROR" |
https://ror.org/00240q980 |
Funders
Funder type
University/education
Department of Pharmacology and Anaesthesiology, Padua University (Italy)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
