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

NCT ID: NCT02780765

Last Updated: 2018-09-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cancer of Head and Neck

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Heated humidifier group

30 postoperative patients with overnight endotracheal intubation will be supplied humidified oxygen using Heated Humidifier (HH). Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. The suctioning of ETT will be done once every 2 hourly by nurse/ doctor/trained personnel.

Group Type EXPERIMENTAL

heated humidifier

Intervention Type DEVICE

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

Mist humidifier group

30 postoperative patients with overnight endotracheal intubation will be supplied humidified oxygen using mist nebuliser. Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. The suctioning of ETT will be done once every 2 hourly by nurse/ doctor/trained personnel.

Group Type ACTIVE_COMPARATOR

mist humidifier

Intervention Type DEVICE

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

Interventions

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heated humidifier

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

Intervention Type DEVICE

mist humidifier

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tata Memorial Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Vijaya P Patil

professor and Anaesthetist

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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1665

Identifier Type: -

Identifier Source: org_study_id

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