Broncho-alveolar Lavage Under Noninvasive Ventilation With Propofol TCI in Patient With AHRF

NCT ID: NCT00741949

Last Updated: 2011-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2011-06-30

Brief Summary

Fiberoptic bronchoscopy (FOB) is an important tool for the diagnosis of pulmonary diseases, more particularly in infectious pneumonia. In patients with severe acute hypoxemic respiratory failure, FOB may be contra-indicated until the patient is intubated and control of its oxygenation obtained. In the literature several authors showed that performing FOB under non invasive ventilation (NIV) preserved oxygenation of the patient; and the recent French Consensus on NIV recommends performing FOB under NIV in patients with acute hypoxemic respiratory failure.

Nevertheless this procedure remains uncomfortable in most patients with respiratory failure. In addition, patient's agitation may lead to desaturation, and compromise the realization of FOB.

Detailed Description

In acute hypoxemic respiratory failure, FOB with BAL can be life threatening because of a deep oxygen desaturation. Performing FOB under NIV has been shown efficient to prevent episodes of desaturation. Several modes of ventilation have been tried ; Continuous Positive Airways Pressure and Pressure Support Ventilation both showed superiority when compared to oxygen supplementation alone. The recent French consensus on NIV recommends performing FOB under NIV in hypoxemic conditions.

Efficacy of NIV can be altered by patient agitation or asynchronism with the ventilator. Though, some authors have proposed the use of sedative agents like remifentanyl during NIV.

To our knowledge, none study has evaluated the beneficial effect of sedation during a FOB with BAL under NIV.

Propofol is an anesthetic agent which can be administered in TCI, to maintain a constant concentration in the target cerebral compartment. Propofol is widely used in different types of anesthesia. Using the same concept, authors have reported its use in sedation, with smaller target concentrations. TCI sedation with propofol preserves patient's spontaneous ventilation, and does not alter hemodynamic parameters.

Our hypothesis is that sédation by TCI with propofol will lead to best oxygen saturation than without this intervention in patients with acute hypoxemic respiratory failure and undergoing FOB with BAL under NIV.

Thus, we designed a randomized controlled study. Eligible patients will be randomized in two groups. In the treatment group, patients will receive sedation with propofol during the procedure of FOB under NIV. In the other group, patients will receive a placebo during the same procedure. Patients and fibroscopist won't be aware of the randomization group

Conditions

Respiratory Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

1

Group Type: EXPERIMENTAL

Propofol

Intervention Type: DRUG

Sedation in TCI with propofol

2

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Isotonic saline solution infusion

Interventions

Propofol

Sedation in TCI with propofol

Intervention Type: DRUG

Placebo

Isotonic saline solution infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Acute respiratory failure defined by clinical signs of respiratory failure (polypnea, use of accessory respiratory muscle) and a PaO2/FiO2 ratio < 250
• Need for a diagnosis FOB with BAL
• Informed consent signed

Exclusion Criteria

• Contraindication of NIV
• FOB with bronchial biopsies
• Acute coronary syndrome
• Thrombopenia < 30.000 / mm3 despite platelets transfusion
• Coagulation disorders
• PaO2/FiO2 ratio < 80 under NIV
• Persistent respiratory acidosis under NIV (pH < 7,32)
• Propofol allergy
• Xylocaïne allergy
• Pregnancy
• Age < 18 years or > 90 years
• Weight > 150 kg or < 30 kg
• Inclusion in another clinical protocol

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin CLOUZEAU, Dr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Antoine BENARD, Dr

Role: STUDY_CHAIR

University Hospital, Bordeaux

Locations

Centre hospitalier Libourne

Libourne, , France

University Hospital Bordeaux, Groupe Hospitalier Pellegrin

Bordeaux, , France

Countries

France

References

Constantin JM, Schneider E, Cayot-Constantin S, Guerin R, Bannier F, Futier E, Bazin JE. Remifentanil-based sedation to treat noninvasive ventilation failure: a preliminary study. Intensive Care Med. 2007 Jan;33(1):82-7. doi: 10.1007/s00134-006-0447-4. Epub 2006 Nov 14.

Reference Type: BACKGROUND

PMID: 17103141 (View on PubMed)

Nieuwenhuijs D, Sarton E, Teppema LJ, Kruyt E, Olievier I, van Kleef J, Dahan A. Respiratory sites of action of propofol: absence of depression of peripheral chemoreflex loop by low-dose propofol. Anesthesiology. 2001 Oct;95(4):889-95. doi: 10.1097/00000542-200110000-00017.

Reference Type: BACKGROUND

PMID: 11605929 (View on PubMed)

Other Identifiers

CHUBX 2007/29

Identifier Type: -

Identifier Source: org_study_id