Clinical Trial Assessing Two Protocols to Withdraw Non-invasive Ventilation in Hypercapnic Respiratory Failure

Hospital Clinic of Barcelona

Status and phase: Completed; Phase 4

Conditions: Hypercapnic Respiratory Failure

Treatments: Device: Nocturnal non-invasive ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT00775710

NIV-JS1

Details and patient eligibility

About

The purpose of the study is to determine the optimal method to withdraw non-invasive ventilation after an episode of hypercapnic respiratory failure.

Enrollment: 128 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute hypercapnic respiratory failure.
• Use of NIV to treat respiratory failure.
• Persistence of hypercapnia after discontinuation of NIV

Exclusion criteria

• Home NIV
• Facial or cranial trauma or surgery,
• Recent gastric or esophageal surgery,
• Active upper gastrointestinal bleeding,
• Excessive amount of respiratory secretions,
• Tracheostomy
• Lack of cooperation

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups

1

Active Comparator group

Description:

Non-invasive ventilation is maintained during three nights after recovery of an episode of hypercapnic respiratory failure.

Treatment:

Device: Nocturnal non-invasive ventilation

2

No Intervention group

Description:

Discontinuation of NIV after the recovery of hypercapnic respiratory failure, without prolong it during night.