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Completed

NCT Number: NCT03237351

Goal Directed Fluid Therapy Guided Fluid Management in Pneumoresection

Perioperative fluid management is a key component of anesthetic management during thoracic surgery. On one hand, fluid restriction could compromise perfusion of vital organs and surgical anastomosis. On the other hand, fluid overload could lead to cardiopulmonary complications, notably pulmonary edema, which carries a high mortality rate. Perioperative fluid management to avoid postpneumonectomy pulmonary edema has been previously reviewed. Therefore, to achieve the balance between preventing fluid overload and optimising organ perfusion, the practical index to guide fluid management, which can predict whether fluid loading will improve haemodynamic conditions in an individual patient, would be very valuable during lung surgery. Perioperative goal-directed fluid therapy (GDFT) is a cornerstone of tissue perfusion and oxygenation, and it can improve surgical outcomes. Respiratory variations of arterial pressure [i.e. pulse pressure variation (PPV) and systolic pressure variation] can predict fluid responsiveness in mechanically ventilated patients under various conditions. Therefore, pressure variations are increasingly being advocated for fluid management.This study will discuss the effects of pulse pressure variation(PPV) in different level during anesthesia on patients with oxygenation index and short-term prognosis undergoing video-assisted thoracoscopic surgery for pneumoresection.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shenzhen Second People's Hospital

Shenzhen, Guangdong, 518035, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiologists physical status I-III; aged 18-60 years old; BMI 18.5 ~ 28 kg/m2

Exclusion criteria

  • Refused to participate in the experiment, hepatic/renal/cardiac dysfunction, severe valvular disease, frequent arrhythmia, moderate anemia and severe electrolyte disturbance before operation.

Treatment and study plan

Fluid therapy

Device

Conventional therapy group: conventional arterial blood pressure monitoring. Low value of PPV group and high value of PPV group:pulse pressure variation monitoring with arterial blood pressure monitoring.

Primary outcomes

  1. Change from Baseline Oxygenation Index in 48 hours

    Time frame: Before induction, 5 minutes before the end of one-lung ventilation, 48 hours after the operation

Secondary outcomes

  1. The duration of surgery

    Time frame: During surgery period

  2. The duration of mechanical ventilation

    Time frame: During surgery period

  3. Crystalloid administered

    Time frame: During surgery period

  4. Colloid administered

    Time frame: During surgery period

  5. Blood loss

    Time frame: During surgery period

  6. Urine output

    Time frame: During surgery period

  7. Number of patients received vasopressor

    Time frame: During surgery period

  8. Blood pressure

    Time frame: Before the surgery and 48 hours after surgery

  9. Leukocyte

    Time frame: Before the surgery and 48 hours after surgery

  10. Hematocrit

    Time frame: Before the surgery and 48 hours after surgery

  11. Complication until hospital discharge

    Time frame: 1 month after surgery

  12. Hospital stay postoperatively

    Time frame: 1 month after surgery

Sponsors and collaborators

Lead sponsor

ZhiHeng Liu

Other

Registry information

Official study title

Goal Directed Fluid Therapy Guided Fluid Management in Pneumoresection: a Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 2, 2017
Registry last updated
Apr 22, 2020

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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