Comparison of Two Ventilator Mode During the Night: New Strategy of Mechanical Ventilation Weaning

COPD Exacerbation Clinical Trial

— REVENTIL  

Official title:

Pressure Controlled Ventilation Versus Pressure Support Ventilation During the Night: New Strategy of Mechanical Ventilation Weaning?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01573481
• Other study ID #: PI2012_843_0016
• Status: Completed
• Phase: N/A
• First received: February 22, 2012
• Last updated: August 3, 2016
• Start date: January 2012
• Est. completion date: January 2015

Study information

• Verified date: August 2016
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD Exacerbation
• Weaning Failure

Intervention

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.
• 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).

Locations

Country	Name	City	State
France	Pneumologie et Réanimation Respiratoire	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

References & Publications (22)

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Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. — View Citation

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. — View Citation

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weaning duration	weaning duration in days (from the first day with spontaneous ventilation to extubation)	between one to 21 days (the study will begin when patient presents weaning criteria and will stop 48 days after extubation.)	No
Secondary	weaning failure	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	48 hours	No
Secondary	Quantity and quality of sleep	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.	1 to 21 days	No