Study to Compare the Effect of Two Different Types of Humidifier on the Endotracheal Tube Patency

60 post operative patients who are kept intubated overnight & are spontaneously breathing will be either supplied humidified oxygen Heated Humidifier(HH) or conventional mist nebulizer.

Temperature of inspired gas at the Y piece will be measured.

Sterile water will be used for HH & Mist nebuliser.

The suctioning of endotracheal tube (ETT) will be done once every 2 hourly by nurse/ doctor/trained personnel and additional suctioning if required.

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Key information

Conditions

Cancer of Head and Neck Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

60 post operative patients who are kept intubated overnight & are spontaneously breathing will be selected in Tata Memorial Hospital (TMH), Mumbai. 30 patients will be supplied through humidified oxygen using FISHER & PAYKEL MR 370 Heated Humidifier(HH) & 30 patients through conventional mist nebulizer.

Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. Continuous monitoring of temperature will be done using standard monitor.

The reusable HH will be subjected to disinfection between patients. Sterile water will be used for HH & Mist nebuliser.

The suctioning of endotracheal tube (ETT) will be done once every 2 hourly by nurse/ doctor/trained personnel.

Based on patient's clinical condition , additional suctioning will be done. Frequency of additional suctioning , reason for suctioning will be noted.

Information regarding the age, sex, type of surgery of the patient, co-morbidity if any size of ETT, the time of commencement of humidification , duration of use of humidifier, time of extubation, any complication leading to discontinuation of humidifier, frequency of refilling of nebulizer chamber, volume of ETT before intubation etc. will be noted.

The amount of Endotracheal tube blockade caused by secretion will be measured immediately following extubation.

The volume of Endotracheal tube secretion / amount of blockade will be assessed by the following process-

The bevel end & Murphy's eye of the Endotracheal tube will be sealed using sterile insulating tape so that it become water tight. The tube will be gradually filled with measured amount of sterile fluid using small volume syringe to increase the accuracy of measurement. The amount of fluid it can hold will be measured & noted.
The volume of extubated tube will be measured in the similar way.
The measured volume of the Extubated Endotracheal tube will be subtracted from the actual volume of the particular Sized ETT ( measured before intubation).
The result obtained after this subtraction will be the volume of secretion or the volume of ETT that has been blocked.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

American Society of Anaesthesiologists (ASA) 1 and 2 adult Patients
Undergoing surgery for head and neck cancer
Requiring overnight endotracheal tube & breathing spontaneously

Exclusion criteria

Patients with major cardiac diseases( coronary artery disease, Valvular diseases)
Patients having gross chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, cystic fibrosis.
Smokers(abstinence period less than 3 months)
Patient in drugs having sialogogue properties.
Patient on drugs having anti-sialogogue properties

Treatment and study plan

heated humidifier

Device

30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using Heated Humidifier(HH)

mist humidifier

Device

30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using mist humidifier

Primary outcomes

Extent of Blockade of Endotracheal Tube Assessed by Change in the Endotracheal Tube Volume

Time frame: At baseline just before intubation and 24 hours from time of ICU admission

The bevel end & Murphy's eye of the Endotracheal tube was sealed using sterile insulating tape so that it becomes water tight. The tube was gradually filled with measured amount of sterile fluid using small volume syringe to increase the accuracy of measurement. The amount of fluid it can hold was measured & noted
Assess the Increase in Nurses Work Load

Time frame: At baseline just before intubation and 24 hours from time of ICU admission

Investigators will assess nursing workload by frequency of filling of humidifier chamber.

Sponsors and collaborators

Lead sponsor

Tata Memorial Hospital

Other Gov

Registry information

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2017
First posted: May 23, 2016
Registry last updated: Sep 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed