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OpenTrials
Completed

NCT Number: NCT02114567

Is it Necessary to Set External PEEP in AECOPD Patients

Acute exacerbation of chronic obstructive pulmonary disease patients with intrinsic positive end-expiratory pressure (PEEPi), Neurally adjusted ventilatory assist (NAVA) reduce work of breathing and trigger delay at any external positive end-expiratory pressure (PEEPe) level compared with pressure-support ventilation (PSV)

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing Zhong-Da Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

About this study

All patients randomly underwent a 30 mins PSV and NAVA crossover ventilation (15 mins each) at progressive PEEPe levels. Progressive levels of PEEPe were applied stepwise in increments of 40% of baseline static PEEPi, every 30 mins, from zero to 160% of baseline static PEEPi during the protocol (0, 40%, 80%, 120% and 160% of static PEEPi, respectively). During PSV, pressure support level was set to meet a Vt 6ml/kg, I/E cycling was 30% of the maximum inspiratory peak flow, flow trigger was 1L/min, and inspired fraction of oxygen (FiO2) was set to the similar level before the study protocol. During NAVA, NAVA Level was set at 15 cmH2O / µV and a peak airway pressure limit was set in order to apply the same inspiratory pressure support at each PEEPe level during PSV. The new setting of NAVA was defined as NAVA15. Moreover the trigger was set at 0.5 µV and the I/E cycling fixed at 70% of the peak of EAdi. During the entire protocol, FiO2 and peak air way pressure were maintained the same levels at each PEEPe level between PSV and NAVA. Arterial blood gases were measured at the end of PSV or NAVA15 ventilation at each PEEPe level.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • mechanical ventilation AECOPD patients with Static PEEPi measured by End-expiratory airway occlusion method ≥ of 5 cm H2O
  • Hemodynamics stability (heart rate < 140 beats/min, no vasopressors required, or <5 μg/kg/min dopamine) without any evidence
  • no sedation or on minimal sedation with low dose of morphine (<3mg/h, by continuous intravenous infusion
  • Breathing spontaneously
  • Awake and with positive cooperate

Exclusion criteria

  • tracheostomy
  • treatment abandonment
  • history of esophageal varices
  • gastro-esophageal surgery in the previous 12 months or gastro-esophageal bleeding in the previous 30 days
  • coagulation disorders (INR ratio>1.5 and Activated partial thromboplastin time > 44 s)
  • history of acute central or peripheral nervous system disorder or severe neuromuscular disease

Treatment and study plan

PEEP titration

Other

In both groups, PEEP was titrated and set to 0, 40%PEEPi, 80%PEEPi, and 120%PEEPi

Primary outcomes

  1. trigger work of breathing

    Time frame: 1 day

Secondary outcomes

  1. patient-ventilator synchrony

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Official study title

Neural Triggering and Cycling-off of Pressure Support Ventilation Improves Synchrony and Reduces Inspiratory Effort in Chronic Obstructive Pulmonary Disease.

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 15, 2014
Registry last updated
Jul 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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