Oxygen Supplementation and Ventilator Hyperinflation in the Endotracheal Suction (OSVHES)

NCT02440919 | Active Not Recruiting DMC

• 1 other identifier: 11354813.1.0000.5504
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

This is a double crossover study where all patients are randomly allocated to one of two treatment sequences associated with endotracheal aspiration.The first treatment (A) uses two suctioning methods for each patient: one involving hyperoxygenation with administration of 100% oxygen 1 minute before and after suction (intervention I), and the other hyperoxygenation with oxygen supply to 20% above basal offer (Intervention II) in the same way.The second treatment (B) uses a technique of hyperinflation with the mechanical ventilator (PEEP-ZEEP) associated with hyperoxygenation. The intervention I, uses PEEP-ZEEP offering 20% above basal oxygenation and intervention II uses the PEEP-ZEEP with basal oxygen supply in the same way. All subjects were randomly allocated using sealed envelopes to a treatment sequence A or B on Day 1. Patients received two treatments, at least four hours apart. The first treatment is in the morning and the alternate treatment is performed in the afternoon. On Day 2 the order of the treatments was reversed using the same patient position sequence.The interventions I and II are performed at least 4 hours apart to minimize any carryover effect.

Conditions

Hypoventilation; Hypoxemia

Keywords

Respiratory mechanics; Oxygenation; Suction; Mechanical ventilation; Respiratory therapy; Capnography; Pulmonary Ventilation

Outcome Measures

Primary Outcomes (1)

• Oxygen (SpO2) and Ventilation (ETCO2) measures

  Oxygenation is evaluated by peripheral oxygen saturation (SpO2), measured by a respiratory monitor (DX-2021™ or DX-2023™- Dixtal™. The Impact on oxygenation was detecting hypoxemia with SpO2 values below 90%. Ventilation is evaluated by end-tidal carbon dioxide measured by carbon dioxide sensor (CAPNOSTAT CO2 Sensor, Novametrix Medical Systems Inc.) inserted into the mechanical ventilator circuit Dixtal 3012™ - Dixtal™. The impact on ventilation was detecting hypoventilation with values exceeding 50 mmHg.

  Endotracheal suctioning is carried out according each protocol. Oxygen (SpO2) and ventilation (ETCO2) measures are performed before and after supply oxygen given for 1 minute, 60 seconds after each suctioning, immediately after and 30 minutes the end.

Secondary Outcomes (2)

• Respiratory mechanic measures

  Endotracheal suctioning is carried out according each protocol. Baseline Respiratory mechanic measures are performed before suctioning, immediately after and 30 minutes the end.

• Volumetric capnography measures

  Endotracheal suctioning is carried out according each protocol. Baseline Volumetric capnography measures are performed before suctioning, immediately after and 30 minutes the end.

Study Arms (4)

Hyperoxygenation - 100% FiO2

OTHER

Hyperoxygenation involved supplying 100% fraction of inspired oxygen (FIO2).

Other: Hyperoxygenation 20% FiO2

Hyperoxygenation - 20% FiO2

OTHER

Hyperoxygenation involved supplying 20% oxygen above FiO2 basal.

Other: Hyperoxygenation 100% FiO2

Hyperinflation - Basal FiO2

OTHER

Ventilator hyperinflation, with keeping the oxygen already offered to the patient.

Other: Hyperinflation (PEEP- ZEEP) 20% FiO2

Hyperinflation - 20% FiO2

OTHER

Ventilator hyperinflation and hyperoxygenation involved supplying 20% oxygen.

Other: Hyperoxygenation 20% FiO2; Other: Hyperinflation (PEEP- ZEEP) Basal FiO2

Interventions

Hyperoxygenation 100% FiO2 OTHER

Endotracheal suction associated with Hyperoxygenation involved supplying 100% oxygen.

Hyperoxygenation - 20% FiO2

Hyperoxygenation 20% FiO2 OTHER

Endotracheal suction associated with Hyperoxygenation involved supplying 20% oxygen above FiO2 basal.

Hyperinflation - 20% FiO2; Hyperoxygenation - 100% FiO2

Hyperinflation (PEEP- ZEEP) Basal FiO2 OTHER

Endotracheal suction associated ventilator hyperinflation (PEEP-ZEEP maneuver) and involved no hyperoxygenation, keeping the oxygen already offered to the patient.

Hyperinflation - 20% FiO2

Hyperinflation (PEEP- ZEEP) 20% FiO2 OTHER

Endotracheal suction associated ventilator hyperinflation (PEEP-ZEEP maneuver) and hyperoxygenation involved supplying 20% oxygen.

Hyperinflation - Basal FiO2

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mechanical ventilation for more than 12h
• Hemodynamic stability
• Presence of indication criteria of endotracheal aspiration procedure

You may not qualify if:

• High doses of vasopressor amines amines and/or severe arrhythmias
• Hemoglobin \< 7 g/dL
• FiO2 ≥ 0.6
• PEEP ≥ 10 cmH2O
• Conditions: rib fractures, chest drain, severe bronchospasm, pneumothorax not drained and tracheostomy
• Contraindications of ventilator hyperinflation(PEEP-ZEEP): intracranial pressure \> 10 mmHg, bleeding disorders, accented degrees of gastroesophageal reflux and bullous lung disease.

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead

Study Sites (1)

The ICU of Hospital Santa Casa de Misericordia of Batatais

Batatais, São Paulo, 14300-000, Brazil

Location

Related Publications (5)

• Rogge JA, Bunde L, Baun MM. Effectiveness of oxygen concentrations of less than 100% before and after endotracheal suction in patients with chronic obstructive pulmonary disease. Heart Lung. 1989 Jan;18(1):64-71.

  PMID: 2912927 BACKGROUND

• Berney S, Denehy L. A comparison of the effects of manual and ventilator hyperinflation on static lung compliance and sputum production in intubated and ventilated intensive care patients. Physiother Res Int. 2002;7(2):100-8. doi: 10.1002/pri.246.

  PMID: 12109234 BACKGROUND

• Herbst-Rodrigues MV, Carvalho VO, Auler JO Jr, Feltrim MI. PEEP-ZEEP technique: cardiorespiratory repercussions in mechanically ventilated patients submitted to a coronary artery bypass graft surgery. J Cardiothorac Surg. 2011 Sep 13;6:108. doi: 10.1186/1749-8090-6-108.

  PMID: 21914178 BACKGROUND

• de Freitas Vianna JR, Pires Di Lorenzo VA, Lourenco da S Simoes MM, Guerra JL, Jamami M. Effects of Zero PEEP and < 1.0 FIO2 on SpO2 and PETCO2 During Open Endotracheal Suctioning. Respir Care. 2020 Dec;65(12):1805-1814. doi: 10.4187/respcare.07435. Epub 2020 Jul 7.

  PMID: 32636279 DERIVED

• Vianna JR, Pires Di Lorenzo VA, Simoes MM, Jamami M. Comparing the Effects of Two Different Levels of Hyperoxygenation on Gas Exchange During Open Endotracheal Suctioning: A Randomized Crossover Study. Respir Care. 2017 Jan;62(1):92-101. doi: 10.4187/respcare.04665. Epub 2016 Nov 15.

  PMID: 28003557 DERIVED

MeSH Terms

Conditions

Hypoventilation; Hypoxia

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jacqueline RF Vianna, Master

  UFSCar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's degree

Study Record Dates

• First Submitted: March 3, 2015
• First Posted: May 12, 2015
• Study Start: June 1, 2013
• Primary Completion: January 1, 2015
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 15, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)