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

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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

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.

Condition or disease Intervention/treatment Phase
Surgical Procedure, Unspecified Procedure: Breathing exercises Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 171 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Arm Intervention/treatment
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
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.


Active Comparator: Flow oriented incentive spirometry
patients performed breathing exercises using flow oriented incentive spirometer during five postoperative days
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.


Active Comparator: Deep breathing group
patients performed deep breathing exercises without any device during five postoperative days
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.


Active Comparator: Continuous positive airway pressure group
patients performed breathing exercises using continuous positive airway pressure group during five postoperative days
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.





Primary Outcome Measures :
  1. thoracoabdominal volume [ Time Frame: third postoperative day ]
    thoracoabdominal volume was evaluated by kinematics (optoelectronic plethysmograph)


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. activity inspiratory muscles [ Time Frame: third postoperative day ]
    evaluation was performed by surface electromyography



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993602


Locations
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Brazil
Hospital of Clinics of School of Medicine of University of Sao Paulo
Sao Paulo, Brazil, 05403-010
Sponsors and Collaborators
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Principal Investigator: Celso R Carvalho, PhD School of Medicine of University of Sao Paulo
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01993602    
Other Study ID Numbers: 0150/11
FAPESP ( Other Grant/Funding Number: 2010/50120-4 )
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: March 8, 2016
Last Verified: November 2013
Keywords provided by University of Sao Paulo General Hospital:
general surgery
postoperative care
breathing exercises
respiratory muscle
postoperative complications
lung volume measurements
pulmonary ventilations
thoracic wall