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Upper airway passage and throat symptoms due to artificial ventilation in seriously ill patients-a multicentre study

LaryngOTracheal and Upper airway symptoms due to mechanical ventilation after orotracheal intubation in Critically ill PatientS – a Prospective Multicentre Cohort Study - LOTUS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/12/048626
Enrollment
280
Registered
2022-12-30
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J399- Disease of upper respiratory tract, unspecified Health Condition 2: J384- Edema of larynx Health Condition 3: J387- Other diseases of larynx Health Condition 4: J392- Other diseases of pharynx Health Condition 5: K918- Other intraoperative and postprocedural complications and disorders of digestive system Health Condition 6: J958- Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified

Interventions

Intervention1: nil: nil Control Intervention1: nil: nil

Sponsors

Natesh Prabu R
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adults admitted to the intensive care unit Need for invasive mechanical ventilation for >48 hours with an orotracheal tube

Exclusion criteria

Exclusion criteria: Patients on comfort care Recent airway, neck, or oesophageal surgery either before or during ICU stay Pregnant or lactating women Known/ Pre-existing history of dysphagia, airway injury, cranial nerve, or vocal cord/bulbar palsy Tracheostomised patients Neuromuscular diseases

Design outcomes

Primary

MeasureTime frame
To estimate the prevalence of Laryngotracheal and Upper airway symptoms after mechanical ventilation at 6 hours post-extubation.Timepoint: 6 hours—

Secondary

MeasureTime frame
To estimate the burden of laryngotracheal and upper airway symptoms on quality of lifeTimepoint: day 7 day 28;To estimate the prevalence of laryngotracheal and Upper airway symptoms after mechanical ventilation at 24hrs, 72hrs, day 7, and day 28.Timepoint: 24hrs, 72hrs, day 7, and day 28.;To estimate the prevalence of laryngotracheal and Upper airway symptoms after mechanical ventilation in prespecified populations such as stroke, respiratory failure, non-respiratory failureTimepoint: baseline;To evaluate the practice pattern of withholding and advancing feeding peri extubationTimepoint: baseline,24hrs,72hrs,day7;To identify the risk factors associated with Laryngotracheal and Upper airway symptomsTimepoint: baseline—

Countries

India

Contacts

Public ContactNatesh Prabu R

St Johns Medical College Hospital

drnateshrprabu@gmail.com9969523803

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026