- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01993602
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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Sao Paulo, Brésil, 05403-010
- Hospital of Clinics of School of Medicine of University of Sao Paulo
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Aucune intervention: Control group
no intervention was performed in this group during postoperative period,
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Comparateur actif: 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. |
Comparateur actif: 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. |
Comparateur actif: 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. |
Comparateur actif: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
thoracoabdominal volume
Délai: third postoperative day
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thoracoabdominal volume was evaluated by kinematics (optoelectronic plethysmograph)
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third postoperative day
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
postoperative pulmonary complication
Délai: participants will be followed for the duration of hospital stay, an expected average of 10 days
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evaluation of pulmonary complications was performed according to pre-established criteria in the research project
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participants will be followed for the duration of hospital stay, an expected average of 10 days
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
activity inspiratory muscles
Délai: third postoperative day
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evaluation was performed by surface electromyography
|
third postoperative day
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Celso R Carvalho, PhD, School of Medicine of University of Sao Paulo
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 0150/11
- FAPESP (Autre subvention/numéro de financement: 2010/50120-4)
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