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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25536515