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Permissive Hypercapnia, Alveolar Recruitment and Limited Airway Pressures reduce injury in Acute Respiratory Distress Syndrome.

A phase II randomised controlled trial in acute respiratory distress syndrome of permissive hypercapnia, alveolar recruitment and limited airway pressures to determine effects on inflammatory cytokines.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000465459
Acronym
PHARLAP
Enrollment
20
Registered
2007-09-13
Start date
2008-01-01
Completion date
2009-10-01
Last updated
2020-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study has been designed to assess whether a ventilation strategy which maintains alveolar patency by the application of recruitment manoeuvres and elevated PEEP and which limits airway pressures by allowing permissive hypercapnia will reduce lung injury as assessed by serum cytokine levels.

Interventions

Initial setup: After randomization the patient will receive a stepwise recruitment manoeuvre followed by a decrimental positive end expiratory pressure (PEEP) trial commencing at 25cmH20 to determine the optimal PEEP for that patient. Plateau airway pressures will then be reduced until either the tidal volume is < 4ml/Kg, a PaCO2 > 60mmHg in the presence of a plateau pressure under 30cmH20 or significant acidosis are encountered (pH<7.15). Ongoing ventilator management: Recruitment manoeuvres

Initial setup: After randomization the patient will receive a stepwise recruitment manoeuvre followed by a decrimental positive end expiratory pressure (PEEP) trial commencing at 25cmH20 to determine the optimal PEEP for that patient. Plateau airway pressures will then be reduced until either the tidal volume is < 4ml/Kg, a PaCO2 > 60mmHg in the presence of a plateau pressure under 30cmH20 or significant acidosis are encountered (pH<7.15). Ongoing ventilator management: Recruitment manoeuvres will be performed regularly (up to 4 times per day) until the SaO2 >/=95% on FiO2 =40% for 12 hours or FiO2 >/=35% for 1 hour. In addition the arterial pH goal for the intervention patients: 7.15 < pH < 7.45 until the SaO2 >/=95% on FiO2 =40% for 12 hours or FiO2 =35% for 1 hour.

Sponsors

Intensive Care Unit, Alfred Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
15 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

(1) Diagnosis of Acute Respiratory Distress Syndrome based on the American-European Consensus Conference criteria.

Exclusion criteria

Patients were excluded if they had chest trauma, an intercostal catheter with air leak, a pneumothorax on chest x-ray, bronchospasm on auscultation, raised intracranial pressure, mean arterial pressure less than or equal to 60 mmHg, significant arrhythmias or were ventilated for longer than 72 hours.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 29, 2026