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

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

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.

Study Overview

• Status: Completed
• Conditions: Surgical Procedure, Unspecified
• Intervention / Treatment: Procedure: Breathing exercises

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: Interventional
• Enrollment (Actual): 171
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05403-010
    • Hospital of Clinics of School of Medicine of University of Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
thoracoabdominal volume	thoracoabdominal volume was evaluated by kinematics (optoelectronic plethysmograph)	third postoperative day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
activity inspiratory muscles	evaluation was performed by surface electromyography	third postoperative day

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Investigators: Principal Investigator: Celso R Carvalho, PhD, School of Medicine of University of Sao Paulo

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: November 8, 2013
• First Submitted That Met QC Criteria: November 18, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Estimate): March 8, 2016
• Last Update Submitted That Met QC Criteria: March 7, 2016
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: breathing exercises; postoperative care; respiratory muscle; postoperative complications; general surgery; lung volume measurements; pulmonary ventilations; thoracic wall
• Other Study ID Numbers: 0150/11; FAPESP (Other Grant/Funding Number: 2010/50120-4)