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Low Tidal Volume and EVLWI During OLV

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ClinicalTrials.gov Identifier: NCT01762709
Recruitment Status : Completed
First Posted : January 8, 2013
Last Update Posted : July 25, 2013
Sponsor:
Information provided by (Responsible Party):
Dammam University

Brief Summary:
The use of low tidal volume (TV) during one lung ventilation (OLV) for thoracic surgery decreases the incidence of postoperative acute lung injury (ALI). We postulated that the use of low TV during OLV for video-assisted thoracoscopic surgery (VATS) would decrease the extravascular lung water content index (EVLWI). After local ethics committee approval and informed consent, we will randomly allocate 60 patients scheduled for elective VATS to ventilate the dependent lung with VT of 4, 6, or 8 mL/kg (n= 20 for each), I: E ratio 1: 2.5, PEEP of 5 cm H2O, recruitment maneuvers and respiratory rate will be adjusted to maintain normocapnia. Perioperative changes in EVLWI, hemodynamics, oxygenation index will be recorded. Also, the incidence of postoperative ALI, morbidity, hospitalization and mortality will be recorded

Condition or disease Intervention/treatment Phase
Lung Diseases Procedure: The VT 4 ml/kg group Procedure: The VT 6 ml/kg group Procedure: The VT 8 ml/kg group Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Different Tidal Volumes on Extravascular Lung Water Content During One-lung Ventilation for Video-assisted Thoracoscopic Surgery: Dammam University Experience
Study Start Date : April 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : February 2013

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Arm Intervention/treatment
Active Comparator: The VT 4 ml/kg group
Use of tidal volume of 4 ml/kg during one lung ventilation
Procedure: The VT 4 ml/kg group
the dependent lung will be ventilated with a TV of 4 mL/kg (predicted body weight), respectively, whereas FiO2, I: E ratio, PEEP, frequency, Ppk, and a FGF will be maintained as during two-lung ventilation (TLV) and the lumen of the nondependent lung will be left open to air. Dependent lung recruitment maneuvers will be repeated at 30-minute intervals by raising the inspiratory pressure up to 35 cmH2O for 10 seconds.
Active Comparator: The VT 6 ml/kg group
Use of tidal volume of 6 ml/kg during one lung ventilation
Procedure: The VT 6 ml/kg group
the dependent lung will be ventilated with a TV of 6 mL/kg (predicted body weight), respectively, whereas FiO2, I: E ratio, PEEP, frequency, Ppk, and a FGF will be maintained as during two-lung ventilation (TLV) and the lumen of the nondependent lung will be left open to air. Dependent lung recruitment maneuvers will be repeated at 30-minute intervals by raising the inspiratory pressure up to 35 cmH2O for 10 seconds.
Experimental: The VT 8 ml/kg group
Use of tidal volume of 8 ml/kg during one lung ventilation
Procedure: The VT 8 ml/kg group
the dependent lung will be ventilated with a TV of 8 mL/kg (predicted body weight), respectively, whereas FiO2, I: E ratio, PEEP, frequency, Ppk, and a FGF will be maintained as during two-lung ventilation (TLV) and the lumen of the nondependent lung will be left open to air. Dependent lung recruitment maneuvers will be repeated at 30-minute intervals by raising the inspiratory pressure up to 35 cmH2O for 10 seconds.



Primary Outcome Measures :
  1. Extra vascular lung water (EVLW) [ Time Frame: Change from baseline up to 3 hours after surgery. ]
    extra vascular lung water (EVLW)


Secondary Outcome Measures :
  1. Arterial tension to inspired fraction of oxygen (PaO2/FiO2) ratio [ Time Frame: Change from baseline up to 3 hours after surgery. ]
    Arterial tension to inspired fraction of oxygen (PaO2/FiO2) ratio

  2. Arterial carbon dioxide tension (PaCO2) [ Time Frame: Change from baseline up to 3 hours after surgery. ]
    Arterial carbon dioxide tension (PaCO2)

  3. Postoperative complications [ Time Frame: Change from baseline up to 3 hours after surgery. ]
    pulmonary complications



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists physical classes from II to III

Exclusion Criteria:

  • decompensated cardiac diseases
  • pulmonary diseases
  • hepatic diseases
  • renal diseases
  • pulmonary hypertension
  • obesity with a body mass index >35 kg/m2
  • preoperative mechanically ventilated
  • urgent procedures
  • previous history of pneumonectomy, bilobectomy, or lobectomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01762709


Locations
Saudi Arabia
Anesthesiology Department
Al Khubar, Eastern, Saudi Arabia, 31592
Sponsors and Collaborators
Dammam University
Investigators
Principal Investigator: Hatem Qutub, MD Associate Professor
Study Director: Mohamed R El Tahan, MD Assistant Professor

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dammam University
ClinicalTrials.gov Identifier: NCT01762709     History of Changes
Other Study ID Numbers: 2012080
2012082 ( Other Grant/Funding Number: University of Dammam )
First Posted: January 8, 2013    Key Record Dates
Last Update Posted: July 25, 2013
Last Verified: July 2013

Keywords provided by Dammam University:
Video-assisted thoracoscopic surgery
one lung ventilation
low tidal volume
acute lung injury
lung water content

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases