Pressure Support During Chest Wall Compression

This study has been completed.

Sponsor:

Information provided by:

Hospital de Clinicas de Porto Alegre

ClinicalTrials.gov Identifier:

NCT01155648

First received: June 23, 2010

Last updated: July 1, 2010

Last verified: June 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

June 23, 2010

Last Updated Date

July 1, 2010

Start Date ^ICMJE

May 2008

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Variation of mucus secretion aspirated. [ Time Frame: Two years ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01155648 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Hemodynamic and pulmonary parameters. [ Time Frame: Two years ] [ Designated as safety issue: Yes ]

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)

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Pressure Support During Chest Wall Compression

Official Title ^ICMJE

Increasing Pressure Support During Chest Wall Compression is Useful During Respiratory Therapy?

Brief 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.

Detailed Description

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.
Clinical variables and APACHE II were registered.
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).
The amount of variation of mucus secretion aspirated (ΔSa= Sa2-Sa1) at the end was also measured

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Respiration, Artificial
Critical Care

Intervention ^ICMJE

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

Study Arm (s)

Experimental: PSV group.
Chest wall compression plus increase of 10 cmH2O of PSV.

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

Intervention: Device: Chest wall compression for ten minutes in chest

Publications *

Naue Wda S, da Silva AC, Güntzel AM, Condessa RL, de Oliveira RP, Rios Vieira SR. Increasing pressure support does not enhance secretion clearance if applied during manual chest wall vibration in intubated patients: a randomised trial. J Physiother. 2011;57(1):21-6.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2010

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT01155648

Other Study ID Numbers ^ICMJE

07-504

Has Data Monitoring Committee

Responsible Party

Federal University of Rio Grande do Sul, Hospital de Clínicas de Porto Alegre

Study Sponsor ^ICMJE

Hospital de Clinicas de Porto Alegre

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Silvia R Vieira, PhD

Federal University of Rio Grande do Sul, Hospital de Clínicas de Porto Alegre

Information Provided By

Hospital de Clinicas de Porto Alegre

Verification Date

June 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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