Pressure support ventilation during general anaesthesia
| ISRCTN | ISRCTN17382426 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17382426 |
| Secondary identifying numbers | L94/10/04 |
- Submission date
- 26/10/2009
- Registration date
- 23/11/2009
- Last edited
- 09/01/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Xavier Capdevila
Scientific
Scientific
SAR A, Lapeyronie University Hospital
295 Avenue du Doyen G Giraud
Montpellier
34295
France
Study information
| Study design | Prospective randomised comparative three group 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 | The effects of pressure support ventilation on emergence time and ventilatory function in comparison to volume controlled ventilation and spontaneous breathing: a randomised study |
| Study objectives | 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(s) | Local medical ethics committee (CPP Sud Mediterannée IV, Hôpital Lapeyronie, CHRU Montpellier) approved on the 28th October 1994 (ref: L94/10-04) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2005 |
| Completion date | 01/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 12 patients |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 01/01/2009 |
Locations
Countries of recruitment
- France
Study participating centre
SAR A, Lapeyronie University Hospital
Montpellier
34295
France
34295
France
Sponsor information
Lapeyronie University Hospital (France)
Hospital/treatment centre
Hospital/treatment centre
295 Avenue du Doyen G Giraud
Montpellier
34295
France
"ROR" |
https://ror.org/03xzagw65 |
|---|
Funders
Funder type
Hospital/treatment centre
Lapeyronie University Hospital and Montpellier School of Medicine (France)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 23/12/2014 | Yes | No |
