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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01155648
Other study ID # 07-504
Secondary ID
Status Completed
Phase N/A
First received June 23, 2010
Last updated July 1, 2010
Start date May 2008
Est. completion date May 2010

Study information

Verified date June 2010
Source Hospital de Clinicas de Porto Alegre
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare two physiotherapy techniques: chest wall compression versus chest wall compression plus increase of 10 cmH2O in inspiratory pressure.


Description:

1. After being placed in the supine position in bed, with head angle elevation at 30°, patients were randomized to:group 1 (G1): chest wall compression for ten minutes in chest or group 2 (G2): chest wall compression plus increase of 10 cmH2O in IP in PSV for ten minutes in chest.

2. Clinical variables and APACHE II were registered.

3. Parameters analyzed at the beginning (1) and at the end (2) of the protocol were: variation of peak pressure (ΔPp=Pp2-Pp1),variation of tidal volume (ΔVT =VT2-VT1), variation of dynamic compliance (ΔCdyn= Cdyn2-Cdyn1).

4. The amount of variation of mucus secretion aspirated (ΔSa= Sa2-Sa1) at the end was also measured


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date May 2010
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients on mechanical ventilation over 48 hours

- With ventilatory drive

- Hemodynamically stable MAP> 60 mmHg

- With treatment of respiratory therapy

Exclusion Criteria:

- Contra indication of increased positive inspiratory pressure

- Peak pressure in the upper airway > 40 cmH2O

- Osteoporosis diagnosis

- Deny to participate in the study

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Device:
Chest wall compression plus increase of 10 cmH2O in inspiratory pressure during Pressure Support Ventilation for ten minutes in chest.

Chest wall compression for ten minutes in chest


Locations

Country Name City State
Brazil Federal University of Rio Grande do Sul, Hospital de Clínicas de Porto Alegre Porto Alegre Rio Grande do Sul

Sponsors (1)

Lead Sponsor Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Variation of mucus secretion aspirated. Two years Yes
Secondary Hemodynamic and pulmonary parameters. The hemodynamic and pulmonary parameters were collected: Hart rate (HH), respiratory rate (f), mean arterial pressure (MAP) and peripheral arterial saturation of oxygen (SpO2); peak inspiratory pressure (Ppeak),and Tidal volume (VT) measured in the ventilator, dynamic compliance (Cdyn calculated through the formula VT/ Ppeak - PEEP) Two years Yes
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