Clinical trial NCT01993602: Lung Expansion Technics on Chest Wall Mechanics and Preventing Pulmonary Complication After Abdominal Surgery
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Procedure, Unspecified
Keywords: general surgery
postoperative care
breathing exercises
respiratory muscle
postoperative complications
lung volume measurements
pulmonary ventilations
thoracic wall
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2013-11-25
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: thoracoabdominal volume
timeFrame: third postoperative day
Secondary outcomes:
measure: postoperative pulmonary complication
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 10 days
Other outcomes:
measure: activity inspiratory muscles
timeFrame: third postoperative day
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital of Clinics of School of Medicine of University of Sao Paulo
Study officials:
affiliation: School of Medicine of University of Sao Paulo
name: Celso R Carvalho, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.