NCT07854730

Brief Summary

This study aims to evaluate the effect of ventilator hyperinflation combined with body positioning on arterial blood gases in patients with ventilator-associated pneumonia. Forty-two mechanically ventilated patients will be randomly assigned into two groups receiving the intervention in either supine or lateral decubitus positions. Arterial blood gases will be assessed over a 6-day intervention period. The findings are expected to provide evidence regarding the optimal positioning strategy to enhance the effectiveness of ventilator hyperinflation in improving gas exchange in critically ill patients.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Oct 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 2, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

October 5, 2026

Expected
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2026

Last Updated

October 2, 2026

Status Verified

September 1, 2026

Enrollment Period

1 month

First QC Date

September 27, 2026

Last Update Submit

September 27, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • PaCO2

    partial pressure of carbon dioxide in arterial blood, measuring how effectively the lungs eliminate carbon dioxide

    Will be assessed at baseline (day 1) pre the intervention of the 1st session and (day 6) post the intervention of the 12th session.

  • PaO2

    partial pressure of oxygen dissolved in arterial blood plasma, measured through an Arterial Blood Gas (ABG) test.

    Will be assessed at baseline (day 1) pre the intervention of the 1st session and (day 6) post the intervention of the 12th session.

  • SaO2

    the percentage of oxygen-saturated hemoglobin relative to total hemoglobin in arterial blood, typically measured via an invasive arterial blood gas (ABG) analysis with normal values ranging from 95% to 99%

    Will be assessed at baseline (day 1) pre the intervention of the 1st session and (day 6) post the intervention of the 12th session.

  • PaO2/FiO2 (P/F)

    a clinical metric used to evaluate oxygenation efficiency and diagnose the severity of acute hypoxemic respiratory failure or Acute Respiratory Distress Syndrome (ARDS).

    Will be assessed at baseline (day 1) pre the intervention of the 1st session and (day 6) post the intervention of the 12th session.

Secondary Outcomes (1)

  • Pulmonary compliance

    Will be assessed at baseline (day 1) pre the intervention of the 1st session and (day 6) post the intervention of the 12th session.

Study Arms (2)

ventilator hyperinflation from lateral decubitus position

EXPERIMENTAL

This group will receive Ventilator hyperinflation in lateral decubitus position (affected lung uppermost) and Conventional respiratory physiotherapy

Device: Ventilator hyperinflation

Manual hyperinflation for Lateral decubitus position

EXPERIMENTAL

This group will receive manual hyperinflation in Lateral decubitus position and Conventional respiratory physiotherapy

Device: Manual hyperinflation

Interventions

a therapeutic technique used by clinicians (Manual or Ventilator Hyperinflation) to clear secretions and recruit collapsed lung tissue, or an inadvertent complic

ventilator hyperinflation from lateral decubitus position

a respiratory therapy technique that uses a manual resuscitation bag to deliver larger-than-normal, controlled breaths to clear airway secretions and reopen collapsed lung areas

Manual hyperinflation for Lateral decubitus position

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Mechanically ventilated patients ≥ 48 hours
  • Diagnosed with VAP (clinical + chest X-ray)
  • Age: 40-60 years
  • Hemodynamically stable
  • Unilateral lung involvement

You may not qualify if:

  • Bilateral lung disease
  • Unstable cardiovascular conditions
  • Contraindications to positioning
  • Re-intubation cases
  • Presence of pneumothorax or air leak

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor doctor

Study Record Dates

First Submitted

September 27, 2026

First Posted

October 2, 2026

Study Start (Estimated)

October 5, 2026

Primary Completion (Estimated)

November 15, 2026

Study Completion (Estimated)

November 15, 2026

Last Updated

October 2, 2026

Record last verified: 2026-09