Inspiratory Muscle Training Prior to Conventional and Min... | NCT04717817 | Trialant

Inspiratory Muscle Training Prior to Conventional and Min... | NCT04717817 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1: experimental	Experimental	Daily inspiratory muscle training (IMT) using an IMT Threshold device (Philips) prior to surgery	Device: Inspiratory muscle training (IMT) using an IMT Threshold device (Philips)
Group 2: comparator	Active Comparator	Standard physiotherapy prior to surgery	Other: Standard physiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Inspiratory muscle training (IMT) using an IMT Threshold device (Philips)	Device	Inspiratory muscle training on a daily basis prior to surgery during 2-3 weeks	Group 1: experimental

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pulmonary function (Volumes)	Inspiratory capacity (l), Functional residual capacity (l),Residual volume (l), Total lung capacity (l). Baseline. Diagnosis of normal/obstructive/restrictive lungfunction	Prior to pre-operative physiotherapy
Pulmonary function (Volumes)	Inspiratory capacity (l), Functional residual capacity (l), Residual volume (l), Total lung capacity (l).Diagnosis of normal/obstructive/restrictive lungfunction and evolution after pre-operative physiotherapy.	After 2 weeks of pre-operative physiotherapy (before surgery)
Pulmonary function (Volumes)	Inspiratory capacity (l), Functional residual capacity (l) ,Residual volume (l),Total lung capacity (l). Diagnosis of normal/obstructive/restrictive lungfunction. Evolution after surgery.	approximately 6 days after surgery
Dynamic pulmonary function	Vital capacity (l), FVC: forced vital capacity (l), FEV1: forced expiratory volume in 1 second (l). Baseline. Diagnosis of normal/obstructive/restrictive lungfunction.	Prior to pre-operative physiotherapy
Dynamic pulmonary function	Vital capacity (l), FVC: forced vital capacity (l), FEV1: forced expiratory volume in 1 second (l). Diagnosis of normal/obstructive/restrictive lungfunction and evolution after pre-operative physiotherapy.	After 2 weeks of pre-operative physiotherapy (before surgery)
Dynamic pulmonary function	Vital capacity (l), FVC: forced vital capacity (l), FEV1: forced expiratory volume in 1 second (l).Diagnosis of normal/obstructive/restrictive lungfunction. Evolution after surgery.

Secondary Outcomes

Measure	Description	Time Frame
post-operative pulmonary complications	Melbourne Group Scale (MGS), tool for recognition of postoperative pulmonary complications (PPC), based on 1) Temperature >38◦C 2)White blood cell count >11.2 or the use of respiratory antibiotics 3)Physician diagnosis of pneumonia or chest infection 4)Chest X-ray report of atelectasis/pneumonia 5)Production of purulent (yellow/green)sputum differing from preoperative 6)Positive signs on sputum microbiology 7)SpO2<90% on room air 8)Re-admission to or prolonged stay (over36 hours) on the intensive care unit/highdependency unit for respiratory problems. Postoperative pulmonary complications are defined as a score of four or more positive variables. the occurence of PPC is an endpoint in this study.