Clinical trial NCT04118244: A Functional Test to Assess Fluid Status During Lung Protective Ventilation Strategies
Official title: Development of a Functional Test to Assess Fluid Status During Lung Protective Ventilation Strategies in the Operating Room.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients Receiving Protective Lung Ventilation
Patients in Grey Zone (3 < Pulse Pressure Variation (PPV) < 17
Lead sponsor: Hallym University Kangnam Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: tertiary care center

Brief summary: Dynamic preload indices, such as pulse pressure variation (PPV) and stroke volume variation (SVV) are generally accepted as accurate indicator of fluid responsiveness in mechanically ventilated patients. Because SVV and PPV are generated by the pressure transmitted from the airways to the pleural and pericardial spaces, their reliability is limited in patients receiving low tidal volume (VT) ventilation and in those with a driving pressure lower than 20 cm H2O.

Lung-protective ventilation using low VT with positive end expiratory pressure (PEEP) has recently been demonstrated to significantly improve postoperative outcome, and its application is gradually increasing in surgical patients. However, protective ventilation alters the predictability of dynamic preload indices and thus limits their use in the operating theatre.

Lung recruitment maneuvers (LRMs), used to reopen collapsed lung, and PEEP have been proposed as the key components of lung-protective ventilation strategy. LRM increases intrathoracic pressure, which in turn causes a transient decrease in stroke volume (SV) and arterial pressure; this may depend on preload status. Interestingly, recent study reported that the augmented PPV during LRM using vital capacity maneuver (VCM, continuous positive airway pressure of 30 cm H2O for 10 s) could predict preload responsiveness under open chest condition.

Investigators hypothesized that the augmented PPV and SVV by a stepwise LRM with incremental PEEP could represent a functional test to suggest preload responsiveness and, therefore, predict fluid responsiveness. The aims of the current study were (1) to assess the ability of augmented PPV and SVV during stepwise LRM-induced to predict fluid responsiveness in mechanically ventilated patients in the operating room, (2) to assess the ability of stepwise LRM-induced decrease in SV (ΔSV-LRM) to predict fluid responsiveness.


Eligibility criteria: Inclusion Criteria:

* Adult patients receiving laparotomy and lung protective ventilation

Exclusion Criteria:

* preoperative arrhythmia
* Severe bradycardia
* Moderate to severe valvular disease
* left ventricular ejection fraction \< 50%
* Poorly controlled hypertension (systolic BP \> 160 mmHg)
* Patients with renal insufficiency (creatinine \> 1.5 mg/dL)
* Moderate to severe liver disease
* BMI \>.30 or \< 15 kg/ m2
* preexisting pulmonary disease
* FEV1 \< 60% of predicted value

Primary outcomes:
measure: PPV_augmented
timeFrame: During the last 5 second of lung recruitment maneuver
measure: SVV_augmented
timeFrame: During the last 5 second of lung recruitment maneuver
Secondary outcomes:
measure: ΔSV_LRM
timeFrame: During the last 5 second of lung recruitment maneuver
measure: ΔETCO2_LRM
timeFrame: During the last 5 second of lung recruitment maneuver
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangnam Sacred Heart Hospital, Hallym University College of Medicine
Study officials:
References: