Recruitment Manoeuvres in Critically Ill Patients

NCT05508724 | Completed

• 2 other identifiers: PID16097IRAS 306692
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Diseases of the lungs can be life-threatening. When these organs fail to adequately work, treatments to support their function are offered, often in Intensive Care Units (ICU). Respiratory failure patients may need sedation and placement of a tube in their windpipe so that a mechanical ventilator can take over their breathing until they have recovered enough to breathe again on their own. One problem that occurs in patients under mechanical ventilation is that parts of the lung tissue tend to collapse (atelectasis), reducing the amount of the lung that is able to transfer oxygen and carbon dioxide effectively and even progressing to pneumonia. To address this problem, ICU doctors often perform a procedure named 'recruitment manoeuvre', which involves briefly inflating the patient's lungs with enough pressure to try to open up the collapsed areas of lung. However, fundamental aspects of the change in the functioning of the heart and lungs that occur during and after such manoeuvre are not fully understood. In this study, funded by the University of Oxford, the investigators wish to study patients with respiratory failure who are receiving mechanical ventilation. Participants will be recruited at the ICU of the Royal Berkshire Hospital having their cardiopulmonary data collected over the course of a day. During this period, some patients will be assessed to determine whether they may benefit from a recruitment manoeuvre using a pressure-volume curve. As this assessment is not perfect, the investigators wish to study which features of this curve predict a successful recruitment. The investigators will do this by evaluating the volume of the lung before and after the recruitment manoeuvre is performed using a device named Optical Gas Analyser. A better understanding of the effects of the recruitment manoeuvre will help the investigators to determine how and when such manoeuvres should be performed in critically ill patients.

Conditions

Respiratory Distress Syndrome; Respiratory Insufficiency; Respiratory Failure; Shock Lung

Outcome Measures

Primary Outcomes (1)

• Functional residual capacity

  To determine whether parameters derived from the airway pressure-volume curve predict changes in static measures of lung volume in response to recruitment manoeuvres

  Changes from FRC baseline value measured immediately after PV curve determination and lung recruitment manoeuvre

Secondary Outcomes (2)

• Anatomic dead space

  Changes from anatomic dead space baseline value measured immediately after PV curve determination and lung recruitment manoeuvre

• Ventilation inhomogeneity

  Changes from ventilation inhomogeneity baseline value measured immediately after PV curve determination and lung recruitment manoeuvre

Study Arms (1)

Critically-ill mechanically ventilated patients

Intensive Care patients receiving mechanical ventilation due to respiratory failure

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from Intensive Care Units at the Royal Berkshire Hospital in Reading, England. The study population is constituted of patients receiving mechanical ventilation on ICU due to respiratory failure.

You may qualify if:

• Male and female, aged 18 years or above
• Receiving mechanical ventilation for respiratory failure via an endotracheal tube on ICU

You may not qualify if:

• Consultee indicates patient would be likely to decline enrolment
• Patient is receiving palliative care
• Language barriers prevent sufficiently good communication with patient or consultee for full consent to be obtained

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Royal Berkshire Hospital, Royal Berkshire Foundation Trust

Reading, RG1 5AN, United Kingdom

Location

Related Publications (19)

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MeSH Terms

Conditions

Respiratory Distress Syndrome; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Peter A Robbins, MBBS MA PhD

  University of Oxford

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow in Clinical Pulmonary Physiology

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: August 19, 2022
• Study Start: October 1, 2022
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)