Non Invasive Ventilation in Acute Asthma

Asthma Clinical Trial

Official title:

Non Invasive Ventilation in Acute Asthma

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00510991
• Other study ID #: 0002
• Status: Unknown status
• Phase: Phase 3
• First received: August 2, 2007
• Last updated: February 26, 2008
• Start date: July 2006
• Est. completion date: February 2008

Study information

• Verified date: February 2008
• Source: Postgraduate Institute of Medical Education and Research
• Contact: Digamber Behera, MD
• Phone: 00911722756822
• Email: dbehera[@]indiachest.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the efficacy of noninvasive positive pressure ventilation versus best medical therapy in patients with acute severe asthma

Description:

In the past, the mainstay of treatment for patients progressing to respiratory failure from acute asthma was intubation and mechanical ventilation. Newer strategies to prevent these intubations to prevent the inherent complications are being explored in form of various pharmacological means like heliox, magnesium sulfate etc. Non pharmacological strategies among which non invasive positive pressure ventilation (NIPPV) is one of the most challenging after showing success in patients with chronic obstructive airway disease (COPD) and cardiogenic pulmonary edema.

Data on efficacy of NIPPV in the management of AA is sparse but has the potential to improve the management of acute severe asthma. Noninvasive ventilation merits further studies in patients with AA, and some consensus panels have suggested that its widespread application in patients with asthma await such trials.The role of NIPPV is not yet clear and needs further studies and keeping this in view we planned this study to study the role of NIPPV in the management of acute asthma.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 100
• Est. completion date: February 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. History of asthma of at least 1 year

2. FEV1 < 50% of predicted (by age, height, and gender) or FEV1 < 200 L/minute

3. Respiratory rate > 30 breaths/min

4. All patients judged by the attending physician as having an acute attack of asthma ( Inability to speak in sentences in one breath, SaO2 < 92% ,pulsus paradoxus > 10 mm of Hg) -

Exclusion Criteria:

1. Smoking history of > 10 years

2. Chronic obstructive pulmonary disease

3. Endotracheal intubation

4. Room air saturation < 88 % or arterial PaO2 < 55 mm of Hg

5. Hemodynamic instability defined as systolic BP < 90 mm Hg

6. Altered state of consciousness

7. Congestive heart failure

8. Ischemic heart disease

9. Upper airway obstruction

10. Facial deformity

11. Pregnancy

12. Pulmonary infiltrates consistent with pulmonary edema or pneumonia

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• nippv

Locations

Country	Name	City	State
India	PGIMER	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in lung function defined as an increase of at least 50% in FEV1 as compared to baseline value on admission or an increase in FEV1 to > 60% of predicted value		Time to discharge
Primary	Intensive care unit length of stay		Time to discharge
Primary	Hospital length of stay		Time to discharge
Secondary	Improvement in the clinical status		Time to discharge
Secondary	Disappearance of pulsus paradoxus		Time to discharge
Secondary	Improvement in arterial blood gases		Time to discharge
Secondary	Improvement in oxygen saturation		Time to discharge
Secondary	Requirements of FiO2 , medications.		Time to discharge
Secondary	Need for mechanical ventilation		Time to discharge