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

NCT ID: NCT01993602

Last Updated: 2016-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 171 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-10-31

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

Conditions

Surgical Procedure, Unspecified

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

no intervention was performed in this group during postoperative period,

Group Type: NO_INTERVENTION

No interventions assigned to this group

volumetric incentive spirometry

patients performed breathing exercises using volumetric incentive spirometer during five postoperative days

Group Type: ACTIVE_COMPARATOR

Breathing exercises

Intervention Type: PROCEDURE

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.

Flow oriented incentive spirometry

patients performed breathing exercises using flow oriented incentive spirometer during five postoperative days

Group Type: ACTIVE_COMPARATOR

Breathing exercises

Intervention Type: PROCEDURE

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.

Deep breathing group

patients performed deep breathing exercises without any device during five postoperative days

Group Type: ACTIVE_COMPARATOR

Breathing exercises

Intervention Type: PROCEDURE

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.

Continuous positive airway pressure group

patients performed breathing exercises using continuous positive airway pressure group during five postoperative days

Group Type: ACTIVE_COMPARATOR

Breathing exercises

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Celso R Carvalho, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Medicine of University of Sao Paulo

Locations

Hospital of Clinics of School of Medicine of University of Sao Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 25973670 (View on PubMed)

Other Identifiers

FAPESP

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

0150/11

Identifier Type: -

Identifier Source: org_study_id