Condition category
Surgery
Date applied
26/10/2009
Date assigned
23/11/2009
Last edited
09/01/2015
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

Prof Xavier Capdevila

ORCID ID

Contact details

SAR A
Lapeyronie University Hospital
295 Avenue du Doyen G Giraud
Montpellier
34295
France

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

L94/10/04

Study information

Scientific title

The effects of pressure support ventilation on emergence time and ventilatory function in comparison to volume controlled ventilation and spontaneous breathing: a randomised study

Acronym

Study hypothesis

Pressure support ventilation (PSV) used with laryngeal mask airway during general anaesthesia (GA) permitted to reduce general anaesthesia emergence time and propofol consumption, compared to spontaneous breathing (SB) and controlled mechanical ventilation (CMV). An improvement in ventilatory parameters and a decrease in laryngeal mask airway (LMA) leaks were also observed with PSV.

Ethics approval

Local medical ethics committee (CPP Sud Mediterannée IV, Hôpital Lapeyronie, CHRU Montpellier) approved on the 28th October 1994 (ref: L94/10-04)

Study design

Prospective randomised comparative three group 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

Mechanical ventilation

Intervention

SB-group: patients underwent SB throughout the ventilator circuit
CMV-group: patients underwent CMV (expiratory tidal volume: VTe of 8 mL/kg, a respiratory rate (RR) of 10 breaths/min and an inspiratory/total duty cycle (Ti/Ttot) ratio of 1:3 with a time plateau pressure at 15% of the inspiratory time)
PSV-group: patients underwent PSV (PSV level was set to obtain a VTe between 7 - 8 mL/kg and RR between 10 - 16 c/min, inspiratory trigger was fixed at -2 cm H2O)

Ventilation was performed with zero positive end expiratory pressure in all three groups. All data were recorded at baseline (T0: before GA induction), 10 min after GA induction (T1), at the surgical incision (T2), at the end of anaesthetic drugs infusion (T3) and when the patient was totally awake (T4). Drugs consumption during GA and duration of GA were recorded at the end of the surgical procedure. Hemodynamic (HR, MAP) and ventilatory variables (RR, VTi, VTe, Ti/Ttot, plateau pressure, SpO2, PetCO2) were recorded during a 2-min stable state for each period. Peak pressure, plateau pressure and flow were measured with Capnomac Ultima at the tube opening. Airway leaks were determined by noting the difference between inspired and expired tidal volume (VTi-VTe). Airway occlusion pressure (P 0.1 ) 37 was measured at each point except in T1, T2 and T3 for the CMV group. For T0 and T4, ventilatory variables were obtained in awake patients spontaneously breathing through the circuit via a mouth piece with a nose clip.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

1. LMA removal time, determined by repeatedly (every minute) questioning the patient
2. Emergence time, defined as the time to obtain a 10 point score on a five questions test

Secondary outcome measures

1. Propofol consumption
2. Ventilatory function
3. Adverse effects

Overall trial start date

01/01/2005

Overall trial end date

01/01/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients aged 18 - 75 years, either sex
2. American Society of Anaesthesiologists (ASA) grade I - II
3. Scheduled for elective knee arthroscopic surgery under total intravenous anaesthetic (TIVA) with a LMA and mechanical ventilation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

12 patients

Participant exclusion criteria

1. Morbidly obese patients (body mass index [BMI] greater than 35 kg/m^2)
2. Chronic obstructive pulmonary disease (COPD) patients
3. Asthmatic patients
4. Less than 18 years old and more than 75 years old

Recruitment start date

01/01/2005

Recruitment end date

01/01/2009

Locations

Countries of recruitment

France

Trial participating centre

SAR A, Lapeyronie University Hospital
Montpellier
34295
France

Sponsor information

Organisation

Lapeyronie University Hospital (France)

Sponsor details

295 Avenue du Doyen G Giraud
Montpellier
34295
France

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Lapeyronie University Hospital and Montpellier School of Medicine (France)

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25536515

Publication citations

Additional files

Editorial Notes