Effects of Sedation on Transpulmonary Pressure and Lung Homogenous (ARDS)

Southeast University, China

Status: Completed

Conditions: ARDS

Treatments: Drug: Light sedated; Drug: Deep sedated

Study type: Interventional

Funder types: Other

Identifiers

NCT03237806

2012ZDIIKY22.0

Details and patient eligibility

About

The acute respiratory distress syndrome (ARDS) is characterized by severe respiratory failure. Open Lung and Lung Protective Strategy have been proved to improve mortality of ARDS patients. Preserving spontaneous breathing (SB) is good for inflating the lung lobe near diaphram during mechanical ventilation, however, strong respiratory drive could generate more transpulmonary pressure in ARDS patients, which increase the stress and strain in injured lung. Nonetheless, it's not clear if sedative has any effects on transpulmonary pressure of ARDS patients.The purpose of this study is to investigate the effects of sedation on transpulmonary pressure of ARDS patients.

Full description

Further study details as provided by Nanjing Zhong-da Hospital, School of Medicine, Southeast University

Enrollment: 24 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ARDS group patient (1) Acute onset of all of the following criteria within a 48-hour period:

   1. Requires positive pressure ventilation through an endotracheal tube
   2. Bilateral infiltrates consistent with edema on frontal chest radiograph, with a duration of no more than 7 days
   3. PaO2/FiO2 less than 300 while receiving positive end-expiratory pressure (PEEP) at more than 5 cm H2O for at least 4 hours, with a duration of no more than 7 days
   4. No clinical evidence of left atrial hypertension (2) Hemodynamics stable (dopamine <10ug/kg•min or norepinephrine <10ug/kg)

2. Surgical patient Surgical patient requires positive pressure ventilation through an endotracheal tube PaO2/FiO2 more than 300 Hemodynamics stable (dopamine <10ug/kg•min or norepinephrine <10ug/kg)

Exclusion criteria

• Age younger than 18 years or older than 85 years
• Cardiac failure
• Known pregnancy
• Increased intracranial pressure
• Severe neuromuscular disease
• Recent injury or other pathologic condition of the esophagus
• Pneumothorax
• Pleural effusion
• Diaphragmatic hernia
• Severe chronic respiratory disease
• End-stage chronic organ failure
• Expected survival of less than 24 hours
• Participation in another interventional study
• Attending physician declines to give consent for participant to enroll
• Patient or surrogate declines or is unable to give consent

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

24 participants in 3 patient groups

Baseline

No Intervention group

Description:

In this phase, patients were sedated to the level of Ramsay 6 before Deep sedated or Light sedated

Deep sedation

Experimental group

Description:

In this Arm, patients were sedated to the level of Ramsay 5(Deep sedated) by Midazolam IV continuously

Treatment:

Drug: Deep sedated

Light sedation

Experimental group

Description:

In this Arm, patients were sedated to the level of Ramsay 3(Light sedated)by Midazolam IV continuously

Treatment:

Drug: Light sedated