Clinical trial NCT02440919: Oxygen Supplementation and Ventilator Hyperinflation in the Endotracheal Suction (OSVHES)
Official title: Effects of Low Oxygen Supplementation and Ventilator Hyperinflation in the Endotracheal Suction of Mechanically Ventilated Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypoventilation
Hypoxemia
Keywords: Respiratory mechanics
Oxygenation
Suction
Mechanical ventilation
Respiratory therapy
Capnography
Pulmonary Ventilation
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
First posted: 2015-05-12
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed description: Endotracheal suction must be carried out only through precise indication, because it is associated with undesirable effects on the hemodynamic parameters, ventilation, oxygenation and respiratory mechanics.

The hyperoxygenation is one of the methods of prevention of hypoxemia induced by tracheal suction procedure and have been proposed for its efficiency. Another method is the hyperinflation with the mechanical ventilator. Ventilator hyperinflation improves oxygenation, mobilizes the bronchial secretion excess and re-expand the lung collapsed areas.

The PEEP-ZEEP is a ventilator hyperinflation technique, described as a lung inflation through a positive pressure enhancement at the end of expiration (PEEP), followed by rapid lung deflation with an abrupt reduction in the PEEP to ZEEP (0 centimeters of water (cmH2O)).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Oxygen (SpO2) and Ventilation (ETCO2) measures
timeFrame: 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:
measure: Respiratory mechanic measures
timeFrame: Endotracheal suctioning is carried out according each protocol. Baseline Respiratory mechanic measures are performed before suctioning, immediately after and 30 minutes the end.
measure: Volumetric capnography measures
timeFrame: Endotracheal suctioning is carried out according each protocol. Baseline Volumetric capnography measures are performed before suctioning, immediately after and 30 minutes the end.
Other outcomes:
Locations:
city: Batatais
country: Brazil
facility: The ICU of Hospital Santa Casa de Misericordia of Batatais
state: São Paulo
Study officials:
affiliation: UFSCar
name: Jacqueline RF Vianna, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.