Condition category
Nutritional, Metabolic, Endocrine
Date applied
26/08/2008
Date assigned
18/09/2008
Last edited
18/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.istar.unipd.it

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

Publication citations

Additional files

Editorial Notes