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

7 de março de 2016 atualizado por: University of Sao Paulo General Hospital

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.

Visão geral do estudo

Status

Concluído

Intervenção / Tratamento

Descrição detalhada

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

Tipo de estudo

Intervencional

Inscrição (Real)

171

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: Control group
no intervention was performed in this group during postoperative period,
Comparador Ativo: volumetric incentive spirometry
patients performed breathing exercises using volumetric incentive spirometer during five postoperative days

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.

Comparador Ativo: Flow oriented incentive spirometry
patients performed breathing exercises using flow oriented incentive spirometer during five postoperative days

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.

Comparador Ativo: Deep breathing group
patients performed deep breathing exercises without any device during five postoperative days

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.

Comparador Ativo: Continuous positive airway pressure group
patients performed breathing exercises using continuous positive airway pressure group during five postoperative days

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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
thoracoabdominal volume
Prazo: third postoperative day
thoracoabdominal volume was evaluated by kinematics (optoelectronic plethysmograph)
third postoperative day

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
postoperative pulmonary complication
Prazo: 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
participants will be followed for the duration of hospital stay, an expected average of 10 days

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
activity inspiratory muscles
Prazo: third postoperative day
evaluation was performed by surface electromyography
third postoperative day

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Celso R Carvalho, PhD, School of Medicine of University of Sao Paulo

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de janeiro de 2011

Conclusão Primária (Real)

1 de outubro de 2013

Conclusão do estudo (Real)

1 de outubro de 2013

Datas de inscrição no estudo

Enviado pela primeira vez

8 de novembro de 2013

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de novembro de 2013

Primeira postagem (Estimativa)

25 de novembro de 2013

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

8 de março de 2016

Última atualização enviada que atendeu aos critérios de controle de qualidade

7 de março de 2016

Última verificação

1 de novembro de 2013

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 0150/11
  • FAPESP (Número de outro subsídio/financiamento: 2010/50120-4)

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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