Physiological Dead Space Measured by Volumetric Capnography in BiPAP and APRV .

NCT03218943 | Unknown DMC

• 1 other identifier: N-44-2017
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Background and Rationale : Mechanical ventilation is an essential component of the care of patients with respiratory failure.Biphasic positive Airway Pressure (BiPAP) and Airway Pressure release ventilation (APRV) are relatively new modes of mechanical ventilation which can be used in treatment of patients with impaired oxygenation.The effect of using BiPAP and APRV modes on reducing the physiological dead space had not been previously investigated. The investigators hypothesize that using APRV mode will decrease physiological dead space more than BiPAP mode in the mechanically ventilated critically ill patients. Objectives : To assess the physiological dead space with each mode. To assess lung mechanics during the use of the two modes. To assess the effectiveness of ventilation during the use of the two modes. Study population \& Sample size : Sixty adult patients more than 18 years old who are mechanically ventilated patients with P/F ratio less than 300. This sample size was calculated based on the assumption that APRV will decrease dead space by 20% with alpha error 0.05 and power 80%. The mean and Standard deviation of the volume of the dead space assessed in a previous study using BIPAP was 40 Study Design : A randomized controlled non-blinded study with cross-over design. In the Trauma and surgical ICU at 185-Hospital (Kasr Alainy Hospitals). Methods : All mechanically ventilated patients in Trauma and surgical ICU at 185-Hospital (Kasr Alainy Hospitals) will start on pressure controlled ventilation mode (PCV) with inspiratory pressure achieving tidal volume 6-8 ml/kg for 2 hours then they will be randomized into one of the two study groups the BIPAP group or the APRV group . Possible Risk (s) to study population : By adjusting the ventilator parameters properly and continuous monitoring of the patients in the study, there will be no risk facing the patients. Outcome parameter (s): Primary outcome: Physiological dead space will be measured in the two groups after 30 minutes. Secondary outcomes

• Physiological dead space after 3 hours.
• PO2/FiO2 ratio.
• Peak airway and Mean airway pressures.
• PCO2 and PH.
• Dynamic compliance.

Conditions

Ventilation Therapy; Complications

Keywords

BiPAP; APRV; Physiological dead space; volumetric capnography; ARDS; impaired oxygenation; ICU; Mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Physiological dead space

  percentage of vd/vt ( dead space volume/ Tidal volume ) which is measured by volumetric capnography included in the metabolic module on General Electric ventilator (Engstrom Carestation, GE Health care, USA).

  after 30 min. on each mode ( APRV and BiPAP )

Secondary Outcomes (7)

• Physiological dead space.

  after 3 hours on each mode ( APRV and BiPAP ).

• PO2/FiO2 ratio

  after 30 min. and 3 hours on each mode ( APRV and BiPAP ).

• Peak airway pressure

  after 30 min. and 3 hours on each mode ( APRV and BiPAP ).

• Mean airway pressure

  after 30 min. and 3 hours on each mode ( APRV and BiPAP ).

• Dynamic compliance

  after 30 min. and 3 hours on each mode ( APRV and BiPAP ).

Study Arms (2)

APRV ventilation

ACTIVE COMPARATOR

They will start on APRV mode with high pressure (Phi) 20 cmH2O , low pressure(Plo) 5 cmH2O with I:E ratio ( Phi phase: Plo phase ratio ) 4:1 for 3 hours Then, they will return to the initial settings ( PCV ) for 2 hours . then, they will be switched into BiPAP mode with high pressure (Phi) 20 cmH2O , low pressure(Plo) 5 cmH2O with I:E ratio ( Phi phase: Plo phase ratio ) 1:1 for 3 hours. Then left for ventilation according to the preference of the physician in charge.

Device: APRV ventilation mode

BiPAP ventilation

ACTIVE COMPARATOR

They will start on BiPAP mode with high pressure (Phi) 20 cmH2O , low pressure(Plo) 5 cmH2O with I:E ratio ( Phi phase: Plo phase ratio ) 1:1 for 3 hours. Then, they will return to the initial settings ( PCV ) for 2 hours . then, they will be switched into APRV mode with high pressure (Phi) 20 cmH2O , low pressure(Plo) 5 cmH2O with I:E ratio ( Phi phase: Plo phase ratio ) 4:1 for 3 hours. Then left for ventilation according to the preference of the physician in charge.

Device: BIPAP ventilation moood

Interventions

APRV ventilation mode DEVICE

They will start on APRV mode with high pressure (Phi) 20 cmH2O , low pressure(Plo) 5 cmH2O with I:E ratio ( Phi phase: Plo phase ratio ) 4:1 for 3 hours

APRV ventilation

BIPAP ventilation moood DEVICE

start on BiPAP mode with high pressure (Phi) 20 cmH2O , low pressure(Plo) 5 cmH2O with I:E ratio ( Phi phase: Plo phase ratio ) 1:1 for 3 hours

BiPAP ventilation

Eligibility Criteria

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

You may qualify if:

• Adults above 18 years old.
• Patients who are recently mechanically ventilated ( within 48 hours ).
• Patients with P/F ratio less than 300.

You may not qualify if:

• patients with COPD or pneumothorax.
• Patients with acute lung injury.
• patients with Emphysema and Emphysematous bullae .
• patients with broncho-pleural fistula.
• patients with severe hemodynamic instability (on IV Noradrenaline \> 0.8 mic/kg/min).
• patients with cardiomyopathy , and those with stenotic valvular diseases.
• Patients with increased intracerebral pressure.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Department of Anesthesia , intensive care and pain management -faculty of medicine Cairo Uni.- kasr Alainy Hospitals.

Cairo, Egypt

RECRUITING

Related Publications (5)

• Haitsma JJ, Lachmann RA, Lachmann B. Lung protective ventilation in ARDS: role of mediators, PEEP and surfactant. Monaldi Arch Chest Dis. 2003 Apr-Jun;59(2):108-18.

  PMID: 14635498 BACKGROUND

• Hormann C, Baum M, Putensen C, Mutz NJ, Benzer H. Biphasic positive airway pressure (BIPAP)--a new mode of ventilatory support. Eur J Anaesthesiol. 1994 Jan;11(1):37-42.

  PMID: 8143712 BACKGROUND

• Baum M, Benzer H, Putensen C, Koller W, Putz G. [Biphasic positive airway pressure (BIPAP)--a new form of augmented ventilation]. Anaesthesist. 1989 Sep;38(9):452-8. German.

  PMID: 2686487 BACKGROUND

• Verscheure S, Massion PB, Verschuren F, Damas P, Magder S. Volumetric capnography: lessons from the past and current clinical applications. Crit Care. 2016 Jun 23;20(1):184. doi: 10.1186/s13054-016-1377-3.

  PMID: 27334879 BACKGROUND

• Anderson CT, Breen PH. Carbon dioxide kinetics and capnography during critical care. Crit Care. 2000;4(4):207-15. doi: 10.1186/cc696. Epub 2000 Jul 12.

  PMID: 11094503 BACKGROUND

Related Links

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MeSH Terms

Interventions

Continuous Positive Airway Pressure

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Ahmed Elkahwagy

  Department of Anesthesia , intensive care and pain management at kasr Alainy hospitals -faculty of medicine - Cairo Uni. - Egypt

  STUDY DIRECTOR

Central Study Contacts

Ahmed Elkahwagy

CONTACT

00201008390999; dr.qahwagy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator ,Dr. Ahmed Samir Elkahwagy

Model Details: A randomized controlled study with cross-over design.

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: July 17, 2017
• Study Start: August 25, 2017
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: August 22, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)