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

Surgical Procedure, Unspecified Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01993602
• Other study ID #: 0150/11
• Secondary ID: FAPESP
• Status: Completed
• Phase: N/A
• First received: November 8, 2013
• Last updated: March 7, 2016
• Start date: January 2011
• Est. completion date: October 2013

Study information

• Verified date: November 2013
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Surgical Procedure, Unspecified

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital of Clinics of School of Medicine of University of Sao Paulo	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	activity inspiratory muscles	evaluation was performed by surface electromyography	third postoperative day	Yes
Primary	thoracoabdominal volume	thoracoabdominal volume was evaluated by kinematics (optoelectronic plethysmograph)	third postoperative day	Yes
Secondary	postoperative pulmonary complication	evaluation of pulmonary complications was performed according to pre-established criteria in the research project	participants will be followed for the duration of hospital stay, an expected average of 10 days	Yes