Efficacy of Non-instrumental Pleural Chest Physiotherapy

NCT03861897 | Completed

• 1 other identifier: CHRD1815
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 11

Brief Summary

The main purpose of this study is to assess efficacy of non instrumental pleural chest physiotherapy on the recovery of respiratory function, at hospital discharge or 15 days after beginning the pleural chest physiotherapy, compared to physiotherapy with standard mobilization, in patients with infectious pleural effusion, who have received usual medical treatment.

Conditions

Infectious Pleural Effusion

Keywords

Non instrumental physiotherapy; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• Variation of vital capacity theoretical between the first day of inclusion and J15 or the last day of hospitalization

  The Primary Outcome Measure is the variation of the percentage of vital capacity theoretical between the first day of inclusion and J15 or the last day of hospitalization using a portable spirometer (Spirobank II basic). Realized by an appraiser not being aware of the arm of randomization.

  At 15 days after inclusion or the last day of hospitalization

Secondary Outcomes (11)

• Variation of vital capacity theoretical at M1,5 and M3

  At 3 months

• Measures the intensity of the pain: analogue visual scale

  At 3 months

• Measurement of rest dyspnea rated according to the modified Borg modified scale

  At 3 months

• Measurement of effort dyspnea rated according the mMRC scale

  At 3 months

• Measure of quality of life: Respiratory Questionnaire St Georges

  At one month and half

Study Arms (2)

Intervention KRP-NI + KM

EXPERIMENTAL

Realization of Non instrumental pleural chest physiotherapy and Mobilization physiotherapy sessions (KRP-NI)

Other: KRP-NI + KM

Control KM

ACTIVE COMPARATOR

Realization of mobilization physiotherapy sessions (KM)

Other: KM

Interventions

KRP-NI + KM OTHER

Non instrumental pleural chest physiotherapy (KRP-NI), 2 sessions a day on weekdays and 1 session a day on weekends and mobilization physiotherapy (KM), 1 session per day except weekend during the hospitalization. The combination of the two physiotherapy is KRP-NI + KM. Afterward, 3 sessions per week, renewable until M3 of non instrumental pleural respiratory physiotherapy. If necessary the doctor can prescribe sessions of mobilization physiotherapy

Intervention KRP-NI + KM

KM OTHER

Mobilization physiotherapy (1 session per day except weekend) during the hospitalization. Afterward, if necessary the doctor can prescribe sessions of mobilization physiotherapy(KM).

Control KM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ eighteen years old
• to be hospitalized for an infectious pleural outpouring
• to have a liquid pleural outpouring diagnosed by echography or to scan thoracic
• presence of a Exudate according to the criteria of Light, to have at least criteria:
• The ratio of pleural fluid protein to serum protein is greater than 0.5
• The ratio of pleural fluid Lactate dehydrogenase (LDH) and serum LDH is greater than 0.6
• The rate of pleural fluid LDH is \> 2/3 upper limit of normal serum LDH of the laboratory concerned
• presence of at least two of the following criteria:
• fever higher or equal 38°C (100.4°F)
• thoracic pain
• purulent sputum
• purulent pleural effusion at the time of the exploring pleural puncture
• hearth of crackling to the sounding
• Inflammatory syndrome (CRP\>15 mg/l and/or White blood cell \>10 000 /mm3)
• no known radiological hearth before

You may not qualify if:

• Patient having undergone a thoracotomy or thoracoscopy in the six previous months
• Patient having a pneumothorax
• Patient reached of a tuberculosis
• Pregnant woman or nursing
• Patient having a life expectancy lower than three months
• Proven or suspected pleural neoplasia disease
• Patient hemodynamically unstable
• Patient having a respiratory insufficiency requiring the introduction of an artificial ventilation
• Patient carrying a chronic respiratory insufficiency under non-invasive ventilation with the long course
• Patient unable to carry out the exercises of physiotherapy (problem of communication and/or comprehension and/or physical inaptitude)
• Patient transplanted of a solid body, allograft or autograft of hematopoietic stem cells
• Patient with a seropositivity for the known HIV and cluster of differentiation 4 (CD4) \<250/mm3

Sponsors & Collaborators

• Hôpital NOVO: lead

Study Sites (11)

Centre Hospitalier Universitaire Angers

Angers, 49000, France

Location

Hôpital Victor Dupuy

Argenteuil, 95100, France

Location

Hôpital de la Cavale Blanche

Brest, 29200, France

Location

Centre Hospitalier de Cholet

Cholet, 49 300, France

Location

Centre Hospitalier Intercommunal - Créteil

Créteil, 94 000, France

Location

Centre Hospitalier de Dunkerque

Dunkirk, 59240, France

Location

Centre Hospitalier Universitaire de Grenoble

Grenoble, 38700, France

Location

Groupe Hospitalier de la Rochelle

La Rochelle, 17000, France

Location

Hôpital Dupuytren

Limoges, 87000, France

Location

Centre Hospitalier Régional d'Orléans

Orléans, 45067, France

Location

Centre Hospitalier René Dubos

Pontoise, 95303, France

Location

Study Officials

• Frédérique MONTRELAY

  Hôpital NOVO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: March 4, 2019
• Study Start: June 6, 2019
• Primary Completion: September 23, 2024
• Study Completion: December 11, 2024
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (11)