Open Lung Approach Versus Standard Protective Strategies

NCT ID: NCT02798133

Last Updated: 2017-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Collapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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OLA

recruitment maneuver + individualized PEEP

Group Type EXPERIMENTAL

OLA

Intervention Type PROCEDURE

PEEP titration trial for best Cdyn after the alveolar recruitment maneuver

RM-5

recruitment maneuver + fixed standard PEEP

Group Type ACTIVE_COMPARATOR

RM-5

Intervention Type PROCEDURE

Fixed standard PEEP after the alveolar recruitment maneuver

Interventions

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OLA

PEEP titration trial for best Cdyn after the alveolar recruitment maneuver

Intervention Type PROCEDURE

RM-5

Fixed standard PEEP after the alveolar recruitment maneuver

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* i) laparoscopic surgery, ii) patients with previous respiratory disease.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación para la Investigación del Hospital Clínico de Valencia

OTHER

Sponsor Role lead

Responsible Party

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Carlos Ferrando

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Neto AS, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Gajic O, El-Tahan MR, Ghamdi AA, Gunay 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.

Reference Type BACKGROUND
PMID: 26947624 (View on PubMed)

Kacmarek RM, Villar J, Sulemanji D, Montiel R, Ferrando C, Blanco J, Koh Y, Soler JA, Martinez D, Hernandez M, Tucci M, Borges JB, Lubillo S, Santos A, Araujo JB, Amato MB, Suarez-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.

Reference Type BACKGROUND
PMID: 26672923 (View on PubMed)

Ferrando C, Mugarra A, Gutierrez A, Carbonell JA, Garcia 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.

Reference Type BACKGROUND
PMID: 24557111 (View on PubMed)

Ferrando C, Suarez-Sipmann F, Tusman G, Leon I, Romero E, Gracia E, Mugarra A, Arocas B, Pozo N, Soro M, Belda FJ. Open lung approach versus standard protective strategies: Effects on driving pressure and ventilatory efficiency during anesthesia - A pilot, randomized controlled trial. PLoS One. 2017 May 11;12(5):e0177399. doi: 10.1371/journal.pone.0177399. eCollection 2017.

Reference Type DERIVED
PMID: 28493943 (View on PubMed)

Other Identifiers

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OLA

Identifier Type: -

Identifier Source: org_study_id

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