Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Lung Expansion Technics on Chest Wall Mechanics and Preventing Pulmonary Complication After Abdominal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01993602
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : March 8, 2016
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Tracking Information
First Submitted Date  ICMJE November 8, 2013
First Posted Date  ICMJE November 25, 2013
Last Update Posted Date March 8, 2016
Study Start Date  ICMJE January 2011
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2013)
thoracoabdominal volume [ Time Frame: third postoperative day ]
thoracoabdominal volume was evaluated by kinematics (optoelectronic plethysmograph)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2013)
postoperative pulmonary complication [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 10 days ]
evaluation of pulmonary complications was performed according to pre-established criteria in the research project
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 18, 2013)
activity inspiratory muscles [ Time Frame: third postoperative day ]
evaluation was performed by surface electromyography
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Lung Expansion Technics on Chest Wall Mechanics and Preventing Pulmonary Complication After Abdominal Surgery
Official Title  ICMJE COMPARISON OF LUNG EXPANSION TECHNICS ON THORACOABDOMINAL MECHANICS AND THEIR INFLUENCE ON THE INCIDENCE OF PULMONARY COMPLICATIONS AFTER ABDOMINAL SURGERY: A RANDOMIZED AND CONTROLLED CLINICAL TRIAL
Brief Summary The lung expansion techniques are widely used to prevent postoperative pulmonary complications. However, the effect of each technique on thoracoabdominal mechanics after abdominal surgery and if it influences the rate of postoperative pulmonary complications remains unknown. The investigators hypothesis is that the lung expansion technique that more increases lung volume after abdominal surgery, will be the most efficient in preventing postoperative pulmonary complication after abdominal surgery. The investigators objectives will be to compare the effect of different lung expansion techniques on lung volumes and activation of inspiratory muscle, and prevention of pulmonary complications in patients undergoing upper abdominal surgery. This study will involve 171 patients undergoing elective abdominal surgery. Patients will be randomly divided into 5 groups: no therapy group (n=35), continuous positive airway pressure (CPAP, n=34); volumetric incentive spirometry (VIS, n=34); flow oriented incentive spirometry (FIS, n=33) and deep breathing (DB, n=35). The thoracoabdominal mechanics will be assessed before and 3 days after surgery. Complications will be evaluated by a researcher who did not know to which group each patient belongs.
Detailed Description The assessments performed were thoracoabdominal kinematics (by optoelectronic pletysmography)and respiratory muscles activity (by surface electromyography). The follow pulmonary complications were considered: pneumonia, tracheobronchitis, atelectasis and acute respiratory failed
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Surgical Procedure, Unspecified
Intervention  ICMJE Procedure: Breathing exercises

The intervention groups (CPAP, VIS, FIS and DB) used the specific device (or not) according to the group allocation.

The intervention was performed 3 times per day, from 1 to 5 postoperative day. Patients performed 5 sets of 10 repetitions of the specific breathing exercise, with 30 seconds rest between each set.

The sessions were held in the morning, early afternoon and early evening, always supervised by a physiotherapist.

Before starting each session, the patient reported the sensation of pain, and if he quantify pain intensity more than 3 in the visual numeric scale (0 to 10) was asked the doctor to administer analgesics aiming that him to perform properly the breathing exercise.

Study Arms  ICMJE
  • No Intervention: Control group
    no intervention was performed in this group during postoperative period,
  • Active Comparator: volumetric incentive spirometry
    patients performed breathing exercises using volumetric incentive spirometer during five postoperative days
    Intervention: Procedure: Breathing exercises
  • Active Comparator: Flow oriented incentive spirometry
    patients performed breathing exercises using flow oriented incentive spirometer during five postoperative days
    Intervention: Procedure: Breathing exercises
  • Active Comparator: Deep breathing group
    patients performed deep breathing exercises without any device during five postoperative days
    Intervention: Procedure: Breathing exercises
  • Active Comparator: Continuous positive airway pressure group
    patients performed breathing exercises using continuous positive airway pressure group during five postoperative days
    Intervention: Procedure: Breathing exercises
Publications * Lunardi AC, Paisani DM, Silva CCBMD, Cano DP, Tanaka C, Carvalho CRF. Comparison of lung expansion techniques on thoracoabdominal mechanics and incidence of pulmonary complications after upper abdominal surgery: a randomized and controlled trial. Chest. 2015 Oct;148(4):1003-1010. doi: 10.1378/chest.14-2696.

*   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
Actual Enrollment  ICMJE
 (submitted: March 7, 2016)
171
Original Actual Enrollment  ICMJE
 (submitted: November 18, 2013)
137
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • candidates for elective upper abdominal surgery expected to last longer than 120 minutes
  • absent of spine or thoracic deformity
  • no previous lung parenchyma resection
  • no tracheostomy
  • able to understand and perform the maneuvers proposed.

Exclusion Criteria:

  • cancellation of surgery
  • mechanical ventilation for more than 24 hours in the postoperative period
  • need for chest tube use
  • postoperative cardiac complications
  • surgical complication
  • reoperation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01993602
Other Study ID Numbers  ICMJE 0150/11
FAPESP ( Other Grant/Funding Number: 2010/50120-4 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Sao Paulo General Hospital
Study Sponsor  ICMJE University of Sao Paulo General Hospital
Collaborators  ICMJE Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators  ICMJE
Principal Investigator: Celso R Carvalho, PhD School of Medicine of University of Sao Paulo
PRS Account University of Sao Paulo General Hospital
Verification Date November 2013

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