Low Tidal Volume and EVLWI During OLV

NCT01762709 | Completed Phase 1 DMC

• 2 other identifiers: 20120802012082
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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

Conditions

Lung Diseases

Keywords

Video-assisted thoracoscopic surgery; one lung ventilation; low tidal volume; acute lung injury; lung water content

Outcome Measures

Primary Outcomes (1)

• Extra vascular lung water (EVLW)

  extra vascular lung water (EVLW)

  Change from baseline up to 3 hours after surgery.

Secondary Outcomes (3)

• Arterial tension to inspired fraction of oxygen (PaO2/FiO2) ratio

  Change from baseline up to 3 hours after surgery.

• Arterial carbon dioxide tension (PaCO2)

  Change from baseline up to 3 hours after surgery.

• Postoperative complications

  Change from baseline up to 3 hours after surgery.

Study Arms (3)

The VT 4 ml/kg group

ACTIVE COMPARATOR

Use of tidal volume of 4 ml/kg during one lung ventilation

Procedure: The VT 4 ml/kg group

The VT 6 ml/kg group

ACTIVE COMPARATOR

Use of tidal volume of 6 ml/kg during one lung ventilation

Procedure: The VT 6 ml/kg group

The VT 8 ml/kg group

EXPERIMENTAL

Use of tidal volume of 8 ml/kg during one lung ventilation

Procedure: The VT 8 ml/kg group

Interventions

The VT 4 ml/kg group PROCEDURE

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.

The VT 4 ml/kg group

The VT 6 ml/kg group PROCEDURE

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.

The VT 6 ml/kg group

The VT 8 ml/kg group PROCEDURE

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.

The VT 8 ml/kg group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists physical classes from II to III

You may not qualify if:

• 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

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead

Study Sites (1)

Anesthesiology Department

Khobar, Eastern Province, 31592, Saudi Arabia

Location

Related Publications (1)

• Qutub H, El-Tahan MR, Mowafi HA, El Ghoneimy YF, Regal MA, Al Saflan AA. Effect of tidal volume on extravascular lung water content during one-lung ventilation for video-assisted thoracoscopic surgery: a randomised, controlled trial. Eur J Anaesthesiol. 2014 Sep;31(9):466-73. doi: 10.1097/EJA.0000000000000072.

  PMID: 24690891 DERIVED

MeSH Terms

Conditions

Lung Diseases; Acute Lung Injury

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Lung Injury

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Hatem Qutub, MD

  Associate Professor

  PRINCIPAL INVESTIGATOR

• Mohamed R El Tahan, MD

  Assistant Professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2012
• First Posted: January 8, 2013
• Study Start: April 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: February 1, 2013
• Last Updated: July 25, 2013

Record last verified: 2013-07

Locations

SA (1)