Low Tidal Volume and EVLWI During OLV

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dammam University
ClinicalTrials.gov Identifier:
NCT01762709
First received: December 30, 2012
Last updated: July 24, 2013
Last verified: July 2013
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Dammam University:

Primary Outcome Measures:
  • Extra vascular lung water (EVLW) [ Time Frame: Change from baseline up to 3 hours after surgery. ] [ Designated as safety issue: Yes ]
    extra vascular lung water (EVLW)


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

  • Arterial carbon dioxide tension (PaCO2) [ Time Frame: Change from baseline up to 3 hours after surgery. ] [ Designated as safety issue: Yes ]
    Arterial carbon dioxide tension (PaCO2)

  • Postoperative complications [ Time Frame: Change from baseline up to 3 hours after surgery. ] [ Designated as safety issue: Yes ]
    pulmonary complications


Enrollment: 39
Study Start Date: April 2012
Study Completion Date: February 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Dammam University
ClinicalTrials.gov Identifier: NCT01762709     History of Changes
Other Study ID Numbers: 2012080, 2012082
Study First Received: December 30, 2012
Last Updated: July 24, 2013
Health Authority: Saudi Arabia: University of Dammam

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

ClinicalTrials.gov processed this record on July 20, 2014