Recruitment Maneuver After Intubation

Hypoxemia Clinical Trial

Official title:

Recruitment Maneuver Increases Oxygenation After Intubation in Hypoxemic ICU Patients: a Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01014299
• Other study ID #: CHU-0061
• Status: Completed
• Phase: Phase 4
• First received: November 13, 2009
• Last updated: November 23, 2009
• Start date: December 2008
• Est. completion date: November 2009

Study information

• Verified date: November 2009
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of a recruitment maneuver immediately after intubation in hypoxemic patients.

Description:

In the intensive care unit (ICU), acute respiratory failure is a common problem. Airway management in critically ill patients usually requires endotracheal intubation after rapid sequence induction. Induction of anesthesia is a well known cause of dramatic changes in respiratory mechanics and gas exchange. Moreover, when the intubation is for respiratory failure, the underlying pathology increases these modifications. The reduction in lung volume results in a deep hypoxemia after intubation. Moreover, mechanical ventilation applied on a collapsed lung increases the risk of ventilator induced lung injury. Recruitment maneuver, which consists of a transient increased in inspiratory pressure, decreases anesthesia-induced lung collapse and hypoxemia. During early acute respiratory failure, RM increases oxygenation and lung volume and may reduce lung oedema. Some authors have suggested the potential benefit of an early RM after induction of anesthesia in operating room. To date, no study has evaluated the short term effect of a recruitment maneuver performed early after intubation in critically ill patients. Therefore, our aim was to ascertain whether RM, performed immediately after intubation, is safe and more effective at reducing hypoxemia than usual management, in hypoxemic patients requiring intubation for invasive ventilation in the ICU.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adults who met acute respiratory failure requiring intubation

• adults who met hypoxemia, defined by a PaO2 less than 100 mm Hg under a high FiO2 mask driven by at least 10 L/min oxygen.

Exclusion Criteria:

• encephalopathy

• coma

• cardiac resuscitation

• hyperkaliemia (>5.5 mEq/L)

• acute brain injury and recent thoracic surgery

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Hypoxemia

Intervention

Other:
• Recruitment maneuver
Assigned interventions: No intervention after tracheal intubation (control group) Alveolar recruitment maneuver (RM group) immediately after intubation

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

References & Publications (1)

Constantin JM, Futier E, Perbet S, Roszyk L, Lautrette A, Gillart T, Guerin R, Jabaudon M, Souweine B, Bazin JE, Sapin V. Plasma neutrophil gelatinase-associated lipocalin is an early marker of acute kidney injury in adult critically ill patients: a prospective study. J Crit Care. 2010 Mar;25(1):176.e1-6. doi: 10.1016/j.jcrc.2009.05.010. Epub 2009 Sep 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygenation (PaO2) measured 5 min after the onset of mechanical ventilation		5 min after the onset of mechanical ventilation	Yes
Secondary	PaO2 at 30 min after intubation, hemodynamic and microbiologic safety, ICU length of stay, ICU mortality and mechanical ventilation duration.		at 30 min after intubation	Yes