Open Lung Approach Versus Standard Protective Strategies

• Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia (Other)
• Overall Status: Completed
• CT.gov ID: NCT02798133
• Collaborator: (none)
• Enrollment: 36
• Arms: 2
• Duration (Months): 4

Study Details

Study Description

Brief Summary

The aim of this study was to compare the effects of adding a recruitment maneuver (RM) to low tidal volume (VT) ventilation, with or without an individualized post-RM positive end-expiratory pressure (PEEP) setting in lung-healthy patients during anesthesia.

Condition or Disease	Intervention/Treatment	Phase
Lung Collapse	Procedure: OLA; Procedure: RM-5	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Open Lung Approach Versus Standard Protective Strategies: Effects on Driving Pressure and Ventilatory Efficiency During Anesthesia
• Study Start Date: Jul 1, 2014
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OLA recruitment maneuver + individualized PEEP	Procedure: OLA; PEEP titration trial for best Cdyn after the alveolar recruitment maneuver
Active Comparator: RM-5 recruitment maneuver + fixed standard PEEP	Procedure: RM-5; Fixed standard PEEP after the alveolar recruitment maneuver

Outcome Measures

Primary Outcome Measures

1. driving pressure [intraoperative]

   The driving pressure is a physiological ventilatory parameter measured as platteau pressure minus PEEP. This parameter may be associated with postoperative pulmonary complications

Secondary Outcome Measures

1. ventilatory efficiency [intraoperative]

   Ventilatory efficiency measured with volumetric capnography which includes dead space and tidal elimination of carbon dioxide.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• ASA physical status I-III undergoing elective major abdominal surgery including pancreatic-duodenectomy, gastrectomy and liver resection

Exclusion Criteria:

• 1. laparoscopic surgery, ii) patients with previous respiratory disease.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Fundación para la Investigación del Hospital Clínico de Valencia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Ferrando C, Mugarra A, Gutierrez A, Carbonell JA, García M, Soro M, Tusman G, Belda FJ. Setting individualized positive end-expiratory pressure level with a positive end-expiratory pressure decrement trial after a recruitment maneuver improves oxygenation and lung mechanics during one-lung ventilation. Anesth Analg. 2014 Mar;118(3):657-65. doi: 10.1213/ANE.0000000000000105.
• Kacmarek RM, Villar J, Sulemanji D, Montiel R, Ferrando C, Blanco J, Koh Y, Soler JA, Martínez D, Hernández M, Tucci M, Borges JB, Lubillo S, Santos A, Araujo JB, Amato MB, Suárez-Sipmann F; Open Lung Approach Network. Open Lung Approach for the Acute Respiratory Distress Syndrome: A Pilot, Randomized Controlled Trial. Crit Care Med. 2016 Jan;44(1):32-42. doi: 10.1097/CCM.0000000000001383.
• Neto AS, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Gajic O, El-Tahan MR, Ghamdi AA, Günay E, Jaber S, Kokulu S, Kozian A, Licker M, Lin WQ, Maslow AD, Memtsoudis SG, Reis Miranda D, Moine P, Ng T, Paparella D, Ranieri VM, Scavonetto F, Schilling T, Selmo G, Severgnini P, Sprung J, Sundar S, Talmor D, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Amato MB, Costa EL, de Abreu MG, Pelosi P, Schultz MJ; PROVE Network Investigators. Association between driving pressure and development of postoperative pulmonary complications in patients undergoing mechanical ventilation for general anaesthesia: a meta-analysis of individual patient data. Lancet Respir Med. 2016 Apr;4(4):272-80. doi: 10.1016/S2213-2600(16)00057-6. Epub 2016 Mar 4. Review. Erratum in: Lancet Respir Med. 2016 Jun;4(6):e34.

• Responsible Party: Carlos Ferrando, MD, PhD, Fundación para la Investigación del Hospital Clínico de Valencia
• ClinicalTrials.gov Identifier: NCT02798133
• Other Study ID Numbers: OLA
• First Posted: Jun 14, 2016
• Last Update Posted: Apr 26, 2017
• Last Verified: Apr 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Pulmonary Atelectasis

Study Results

No Results Posted as of Apr 26, 2017