Trial Outcomes & Findings for Effects of Respiratory Muscle Training in Mechanically Ventilated Adults (NCT NCT02469064)

NCT ID: NCT02469064

Last Updated: 2023-01-12

Results Overview

Weaning time was considered as time elapsed from beginning of pressure support mode in mechanical ventilation (Pressure support at 10 centimeters of water (cmsH2O) or less) or continuous positive pressure in the airway mode (CPAP) until patient extubation

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 126 participants
• Primary outcome timeframe: Measured by the end of the period of mechanical ventilation, an average expected time of 4 days
• Results posted on: 2023-01-12

Participant Flow

The recruitment period lasted seven months. The collection was performed in an Intensive Care Unit of a IV level clinic in the city of Cali

126 patients were randomized, 3 of them did not comply with the protocol, being assigned to the experimental treatment and receiving conventional treatment. No patient requested to be withdrawn from the study, and no patient had any adverse effects

Participant milestones

Measure	Conventional Physical Therapy Conventional Cardiopulmonary Physical Therapy Cardiopulmonary Physical Therapy: Control group receives Cardiopulmonary Physical Therapy every 6 hours, physical therapy and mechanical ventilation management	Respiratory Muscle Training Experimental group receives as additional treatment respiratory muscle training. Respiratory muscle training: Respiratory muscle training is done twice every day, with 3 series of 10 repetitions each, with a resting pause of two minutes between series (during resting time, patient is connected to mechanical ventilation again). We adjust initial load for respiratory muscle training as 50% of maximum inspiratory pressure (MIP). At the end of every training session, we assess dyspnea (perceived effort) using Modified Borg Scale (23). Four physical therapists are in charge of Respiratory muscle training, these therapists work at intensive care unit (ICU) and have experience with critically ill patients. Cardiopulmonary Physical Therapy: Control group receives Cardiopulmonary Physical Therapy every 6 hours, physical therapy and mechanical ventilation management
Overall Study STARTED	64	62
Overall Study COMPLETED	63	59
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Measure	Conventional Physical Therapy Conventional Cardiopulmonary Physical Therapy Cardiopulmonary Physical Therapy: Control group receives Cardiopulmonary Physical Therapy every 6 hours, physical therapy and mechanical ventilation management	Respiratory Muscle Training Experimental group receives as additional treatment respiratory muscle training. Respiratory muscle training: Respiratory muscle training is done twice every day, with 3 series of 10 repetitions each, with a resting pause of two minutes between series (during resting time, patient is connected to mechanical ventilation again). We adjust initial load for respiratory muscle training as 50% of maximum inspiratory pressure (MIP). At the end of every training session, we assess dyspnea (perceived effort) using Modified Borg Scale (23). Four physical therapists are in charge of Respiratory muscle training, these therapists work at intensive care unit (ICU) and have experience with critically ill patients. Cardiopulmonary Physical Therapy: Control group receives Cardiopulmonary Physical Therapy every 6 hours, physical therapy and mechanical ventilation management
Overall Study Request not to receive intervention.	1	3

Baseline Characteristics

Effects of Respiratory Muscle Training in Mechanically Ventilated Adults

Baseline characteristics by cohort

Measure	Respiratory Muscle Training n=62 Participants Experimental group receives as additional treatment respiratory muscle training. Respiratory muscle training: Respiratory muscle training is done twice every day, with 3 series of 10 repetitions each, with a resting pause of two minutes between series (during resting time, patient is connected to mechanical ventilation again). We adjust initial load for respiratory muscle training as 50% of MIP. At the end of every training session, we assess dyspnea (perceived effort) using Modified Borg Scale (23). Four physical therapists are in charge of Respiratory muscle training, these therapists work at ICU and have experience with critically ill patients. Cardiopulmonary Physical Therapy: Control group receives Cardiopulmonary Physical Therapy every 6 hours, physical therapy and mechanical ventilation management	Conventional Physical Therapy n=64 Participants Conventional Cardiopulmonary Physical Therapy Cardiopulmonary Physical Therapy: Control group receives Cardiopulmonary Physical Therapy every 6 hours, physical therapy and mechanical ventilation management	Total n=126 Participants Total of all reporting groups
Age, Continuous	61 years n=5 Participants	64 years n=7 Participants	62 years n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	26 Participants n=7 Participants	55 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	38 Participants n=7 Participants	71 Participants n=5 Participants
Region of Enrollment Colombia	62 Participants n=5 Participants	64 Participants n=7 Participants	126 Participants n=5 Participants

PRIMARY outcome

Timeframe: Measured by the end of the period of mechanical ventilation, an average expected time of 4 days

Weaning time was considered as time elapsed from beginning of pressure support mode in mechanical ventilation (Pressure support at 10 centimeters of water (cmsH2O) or less) or continuous positive pressure in the airway mode (CPAP) until patient extubation

Outcome measures

Measure	Respiratory Muscle Training n=62 Participants Experimental group receives as additional treatment respiratory muscle training. Respiratory muscle training: Respiratory muscle training is done twice every day, with 3 series of 10 repetitions each, with a resting pause of two minutes between series (during resting time, patient is connected to mechanical ventilation again). We adjust initial load for respiratory muscle training as 50% of MIP. At the end of every training session, we assess dyspnea (perceived effort) using Modified Borg Scale (23). Four physical therapists are in charge of Respiratory muscle training, these therapists work at ICU and have experience with critically ill patients. Cardiopulmonary Physical Therapy: Control group receives Cardiopulmonary Physical Therapy every 6 hours, physical therapy and mechanical ventilation management	Conventional Physical Therapy n=64 Participants Conventional Cardiopulmonary Physical Therapy Cardiopulmonary Physical Therapy: Control group receives Cardiopulmonary Physical Therapy every 6 hours, physical therapy and mechanical ventilation management
Weaning Time From Mechanical Ventilation	5 hours Interval 0.0 to 72.0	5 hours Interval 0.0 to 59.0

SECONDARY outcome

Timeframe: Measured at baseline (baseline MIP) and right before patient extubation (finalMIP, an average of 2 hours)

Population: 24 patients did not reach a measurement of the Final MIP, of them, 14 belonged to the experimental treatment group and 10 to the conventional treatment group; therefore this result was analyzed in 102 patients.

Changes in Maximum Inspiratory Pressure (MIP) was considered as Final MIP minus baseline MIP

Outcome measures

Measure	Respiratory Muscle Training n=48 Participants Experimental group receives as additional treatment respiratory muscle training. Respiratory muscle training: Respiratory muscle training is done twice every day, with 3 series of 10 repetitions each, with a resting pause of two minutes between series (during resting time, patient is connected to mechanical ventilation again). We adjust initial load for respiratory muscle training as 50% of MIP. At the end of every training session, we assess dyspnea (perceived effort) using Modified Borg Scale (23). Four physical therapists are in charge of Respiratory muscle training, these therapists work at ICU and have experience with critically ill patients. Cardiopulmonary Physical Therapy: Control group receives Cardiopulmonary Physical Therapy every 6 hours, physical therapy and mechanical ventilation management	Conventional Physical Therapy n=54 Participants Conventional Cardiopulmonary Physical Therapy Cardiopulmonary Physical Therapy: Control group receives Cardiopulmonary Physical Therapy every 6 hours, physical therapy and mechanical ventilation management
Changes in Maximum Inspiratory Pressure (MIP)	9.43 cmH20 Standard Deviation 17.48	5.92 cmH20 Standard Deviation 3.51

Adverse Events

Respiratory Muscle Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Conventional Physical Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Lina Marcela Sandoval Moreno

Universidad del Valle

Phone: 316 478 0808

Email: linamarce48@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place