Comparison of Two Ventilator Mode During the Night: New Strategy of Mechanical Ventilation Weaning - Full Text View

Purpose

The purpose of the study is to compare pressure controlled continuous mandatory ventilation versus pressure support ventilation during the night for weaning to mechanical ventilation in chronic obstructive pulmonary disease patients and their impact onto sleep quality.

Condition	Intervention
Weaning Failure COPD Exacerbation	Other: pressure support ventilation Other: Pressure controlled ventilation

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Pressure Controlled Ventilation Versus Pressure Support Ventilation During the Night: New Strategy of Mechanical Ventilation Weaning?

Further study details as provided by Centre Hospitalier Universitaire, Amiens:

Primary Outcome Measures:

Weaning duration [ Time Frame: between one to 21 days (the study will begin when patient presents weaning criteria and will stop 48 days after extubation.) ] [ Designated as safety issue: No ]
weaning duration in days (from the first day with spontaneous ventilation to extubation)

Secondary Outcome Measures:

weaning failure [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Failure of weaning = re-intubation, necessity of non invative ventilation support for periods during the day time or death, in the first 48 hours following extubation
Quantity and quality of sleep [ Time Frame: 1 to 21 days ] [ Designated as safety issue: No ]
Polygraphic datas will be analyzed during weaning, integrating: Proportion of sleep stages (I, II, III, IV, REM sleep), overall sleep and awakeness period.

Average ratio of diurnal sleep on total overall sleep, average ratio of diurnal sleep on total sleep at the first day of weaning and the day before extubation; Observation of central apneas from begining of weaning to extubation.

Estimated Enrollment:	30
Study Start Date:	January 2012
Estimated Study Completion Date:	November 2013
Estimated Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Pressure support ventilation Patients in this group are ventilated during the night (10 PM to 9 AM) with pressure support ventilation mode. The level of the pressure support is the same as the previous day. During the day (9 AM to 10 PM), patients are ventilated with pressure support ventilation (the level of pressure support is progressively decreased).	Other: pressure support ventilation Patients in this group are ventilated during the night with pressure support ventilation mode. The level of the pressure support is the same as the previous day.
Active Comparator: Pressure controlled ventilation Patients in this group are ventilated during the night (10 PM to 9 AM) with pressure controlled ventilation mode. The level of inspiratory pressure is set to 20 cm H2O and the respiratory rate is adjusted to avoid any spontaneous breathing (respiratory rate > or equal to 12 breath per min). During the day (9 AM to 10 PM), patients are ventilated with pressure support ventilation (the level of pressure support is progressively decreased).	Other: Pressure controlled ventilation Patients in this group are ventilated during the night (10 PM to 9 AM) with pressure controlled ventilation mode. The level of inspiratory pressure is set to 20 cm H2O and the respiratory rate is adjusted to avoid any spontaneous breathing (respiratory rate > or equal to 12 breath per min).

Arms

Assigned Interventions

Active Comparator: Pressure support ventilation

Patients in this group are ventilated during the night (10 PM to 9 AM) with pressure support ventilation mode. The level of the pressure support is the same as the previous day.

During the day (9 AM to 10 PM), patients are ventilated with pressure support ventilation (the level of pressure support is progressively decreased).

Other: pressure support ventilation

Patients in this group are ventilated during the night with pressure support ventilation mode. The level of the pressure support is the same as the previous day.

Active Comparator: Pressure controlled ventilation

Patients in this group are ventilated during the night (10 PM to 9 AM) with pressure controlled ventilation mode. The level of inspiratory pressure is set to 20 cm H2O and the respiratory rate is adjusted to avoid any spontaneous breathing (respiratory rate > or equal to 12 breath per min). During the day (9 AM to 10 PM), patients are ventilated with pressure support ventilation (the level of pressure support is progressively decreased).

Other: Pressure controlled ventilation

Patients in this group are ventilated during the night (10 PM to 9 AM) with pressure controlled ventilation mode. The level of inspiratory pressure is set to 20 cm H2O and the respiratory rate is adjusted to avoid any spontaneous breathing (respiratory rate > or equal to 12 breath per min).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The patient and/or legal representative of the patient has provided a written informed consent before inclusion in the study
The patients is hospitalized in respiratory and critical care unit (university hospital of AMIENS, FRANCE)
the patient is mechanically ventilated (ventilator model : puritan-bennett B840)
Pulmonary disease,chronic obstructive (Spirometry and Blood Gas Analysis in chronic state before admission)
stable cardiovascular status (cardiac frequency < 140 beats/min and systolic blood pressure : 90-160 mmHg without catecholamines)
midazolam < 0,05mg/kg/h
sufentanyl < 0,05µ/kg/h
the disorder that caused respiratory failure and prompted mechanical ventilation is treated
the clinician suspects the patient may be ready to begin the weaning process
inspiratory oxygen fraction (FiO2) < 50%
positive end-expiratory pressure < or equal 8cmH2O
during the day, the patient tolerate pressure support ventilation (pressure support level < 15cmH2O
respiratory frequency (FR) < 35 breaths/min
tidal volume (VT) > 5ml/kg
PaO2/FiO2 > 200 mmHg
FR/VT < 105 breaths/min/L

Exclusion Criteria:

sleep apnea, central
narcolepsy
Encephalopathy, Metabolic AND Encephalitis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01573481

Contacts

Contact: Andrejak Claire, MD

+33322455910

clandrejak@gmail.com

Locations

France
Pneumologie et Réanimation Respiratoire	Recruiting
Amiens, France, 80000
Contact: Andrejak Claire, MD

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens

Investigators

Principal Investigator:	ANDREJAK Claire, MD	CHU Amiens
Study Director:	JOUNIEAUX Vincent, MD PhD	CHU Amiens
Principal Investigator:	BASILLE Damien, MD	CHU Amiens
Principal Investigator:	ROGER Pierre-Alexandre, MD	CHU Amiens
Principal Investigator:	ROSE Dominique, MD	CHU Amiens
Principal Investigator:	MONCONDUIT Julien, MD	CHU Amiens

More Information

Publications:

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Esteban A, Frutos F, Tobin MJ, Alía I, Solsona JF, Valverdú I, Fernández R, de la Cal MA, Benito S, Tomás R, et al. A comparison of four methods of weaning patients from mechanical ventilation. Spanish Lung Failure Collaborative Group. N Engl J Med. 1995 Feb 9;332(6):345-50.

Esteban A, Alía I. Clinical management of weaning from mechanical ventilation. Intensive Care Med. 1998 Oct;24(10):999-1008. Review.

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Bosma K, Ferreyra G, Ambrogio C, Pasero D, Mirabella L, Braghiroli A, Appendini L, Mascia L, Ranieri VM. Patient-ventilator interaction and sleep in mechanically ventilated patients: pressure support versus proportional assist ventilation. Crit Care Med. 2007 Apr;35(4):1048-54.

Toublanc B, Rose D, Glérant JC, Francois G, Mayeux I, Rodenstein D, Jounieaux V. Assist-control ventilation vs. low levels of pressure support ventilation on sleep quality in intubated ICU patients. Intensive Care Med. 2007 Jul;33(7):1148-54. Epub 2007 May 11.

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Responsible Party:	Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:	NCT01573481 History of Changes
Other Study ID Numbers:	PI11 - Dr ANDREJAK Mlle
Study First Received:	February 22, 2012
Last Updated:	April 5, 2012
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire, Amiens:

WEANING
PRESSURE CONTROLLED CONTINOUS VENTILATION
PRESSURE VENTILATION SUPPORT
SLEEP
POLYGRAPHIC RECORD

Additional relevant MeSH terms:

Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013