Sleep Quality in Mechanically Ventilated Patients

Lawson Health Research Institute

Status: Completed

Conditions: Respiratory Failure

Treatments: Other: PAV; Other: PSV; Other: ACV

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01410149

R-07-106

13114

Details and patient eligibility

About

Patients requiring mechanical ventilation in the ICU will undergo three consecutive nights of polysomnography to record sleep patterns while receiving three modes of mechanical ventilation; Proportional assist ventilation (PAV), Pressure support ventilation (PSV), Assist control ventilation (ACV), applied in random order. The purpose is to determine the effect of mode of mechanical ventilation on patient-ventilator asynchrony and sleep quality.

Enrollment: 13 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-75
• received mechanical ventilation >72 hours
• glasgow coma scale >10
• acute physiology score <13
• ready for partial ventilatory support: intact respiratory drive, PaO2/FiO2 ratio >200 on positive end expiratory pressure (PEEP) less than or equal to 5 cmH2O, and PH of 7.35 to 7.45
• sedation: analgesia at dose not higher than 0.01 mg/kg/hr morphine equivalent x 48 hours, sedation at dose not higher than 0.01 mg/kg/hr lorazepam equivalent x 72 hours.
• anticipate ongoing need for partial ventilatory support for the following 72 hours

Exclusion criteria

• Successful completion of spontaneous breathing trial
• Neurological injury, encephalopathy or abnormal EEG
• History of central sleep apnea
• General anaesthesia within 72 hours from study entry
• Requiring haloperidol >10 mg/24 hours
• hemodynamically unstable
• sepsis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

13 participants in 3 patient groups

PAV

Active Comparator group

Description:

Proportional Assist Ventilation (PAV+ on PB840 ventilator)

Treatment:

Other: PAV

PSV

Active Comparator group

Description:

Pressure Support Ventilation (PSV on PB840 ventilator)

Treatment:

Other: PSV

ACV

Active Comparator group

Description:

Assist Control/ Pressure limited Ventilation (on PB840 ventilator)

Treatment:

Other: ACV